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Gobarani, Rukshar K., Nicholas A. Zwar, Grant Russell, Michael J. Abramson, Billie Bonevski, Anne E. Holland, Eldho Paul, Narelle S. Cox, Sally Wilson, and Johnson George. "Smoking cessation intervention in Australian general practice: a secondary analysis of a cluster randomised controlled trial." British Journal of General Practice 71, no. 707 (January 20, 2021): e458-e464. http://dx.doi.org/10.3399/bjgp.2020.0906.
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BackgroundGPs have limited capacity to routinely provide smoking cessation support. New strategies are needed to reach all smokers within this setting.AimTo evaluate the effect of a pharmacist-coordinated interdisciplinary smoking cessation intervention delivered in Australian general practice.Design and settingSecondary analysis of a cluster randomised controlled trial (RCT) conducted in 41 Australian general practices.MethodIn all, 690 current smokers were included in this study: 373 from intervention clinics (n = 21) and 317 from control clinics (n = 18). A total of 166 current smokers had spirometry-confirmed chronic obstructive pulmonary disease (COPD). In the intervention clinics, trained pharmacists provided smoking cessation support plus Quitline referral. Control clinics provided usual care plus Quitline referral. Those with COPD in the intervention group (n = 84) were referred for home medicines review (HMR) and home-based pulmonary rehabilitation (HomeBase), which included further smoking cessation support. Outcomes included carbon monoxide (CO)-validated smoking abstinence, self-reported use of smoking cessation aids, and differences between groups in readiness-to-quit score at 6 months.ResultsIntention-to-treat analysis showed similar CO-validated abstinence rates at 6 months in the intervention (4.0%) and control clinics (3.5%). No differences were observed in readiness-to-quit scores between groups at 6 months. CO-validated abstinence rates were similar in those who completed HMR and at least six sessions of HomeBase to those with COPD in usual care.ConclusionA pharmacist-coordinated interdisciplinary smoking cessation intervention when integrated in a general practice setting had no advantages over usual care. Further research is needed to evaluate the effect of HMR and home-based pulmonary rehabilitation on smoking abstinence in smokers with COPD.
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Henrikson, Nora B., Melissa L. Anderson, John F. Dickerson, John J. Ewing, Robin Garcia, Erin Keast, Deborah A. King, et al. "Financial concerns of people enrolled in the CAFÉ cancer financial navigation trial." Journal of Clinical Oncology 40, no. 28_suppl (October 1, 2022): 172. http://dx.doi.org/10.1200/jco.2022.40.28_suppl.172.
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172 Background: CAFÉ is a three-arm randomized controlled trial testing whether financial navigation for people with cancer improves quality of life and financial distress compared to enhanced usual care at two integrated health systems (Kaiser Permanente Washington, KPWA; and Kaiser Permanente Northwest, KPNW). Our current objective was to describe financial concerns reported by a subset of participants enrolled and receiving financial navigation in the trial. Methods: We descriptively summarized the financial concerns in participants randomized to receive financial navigation between August 2021 and May 2022 (Total n = 135; KPWA = 75 and KPNW = 60). Participants received either one or three proactive outreach with financial concerns assessment plus any participant-initiated assessment. Navigators followed up with personalized liaison and warm handoff to resources and coordinated with oncology care team and organizational partners about participant cost concerns. We used the study’s bespoke REDCap database, including participant sociodemographic and clinical characteristics and discrete notes entered by CAFE financial navigators. During financial concerns assessments, CAFE navigators recorded the type of each concern: planning and budgeting; care decision-making; or acute financial needs; resource referrals provided; and time to concern resolution. Results: The sample was 36% male; mean age 61 years; and 62% married or living with a partner. Self-reported race/ethnicity was 9% Black, 15% other, and 76% White; 6% reported Hispanic/Latino ethnicity. 43% reported less than four-year college education. Cancer types were 38% breast; 16% prostate; 6% colorectal; 4% lung; and 36% other types. 5% had Medicaid and 44% Medicare. 58% reported < $75,000 total family income in 2021. 16% were enrolled in the KP medical financial assistance (MFA) program. Navigators documented 179 assessments. Number of concerns/participant ranged from zero to 5 (mean = 1.3 concerns/participant). Participants reported a financial concern at 61% of assessments. The most common concern was planning/budgeting (68%), followed by acute financial needs (28%) and care decision-making (3%). Mean time-to-resolution was 22 days (planning/budgeting); 27 days (acute needs) and 33 days (clinical decision-making). The most common resource referrals included the KP MFA (77 times); coordination with KP member services (73 times) (e.g., for cost estimates), community resource navigators (35 times) and nurse navigators (25), and patient financial services (i.e. billing, 10). Conclusions: Proactive assessment by oncology financial navigators identifies financial concerns related to planning for cancer care expenses and acute financial needs. Concerns related to financial hardship as a factor in clinical decision-making were rare. Resource referrals varied by concern type, with time-to-resolution ranging from 22-33 days. Clinical trial information: NCT05018000.
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Seery, Tara Elisabeth, Chaitali Singh Nangia, Leonard S. Sender, Sandeep K. Reddy, and Patrick Soon-Shiong. "Trial in progress: Open-label, randomized, comparative phase 2/3 study of combination immunotherapy plus standard-of-care chemotherapy and SBRT versus standard-of-care chemotherapy for the treatment of locally advanced or metastatic pancreatic cancer." Journal of Clinical Oncology 39, no. 15_suppl (May 20, 2021): TPS4174. http://dx.doi.org/10.1200/jco.2021.39.15_suppl.tps4174.
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TPS4174 Background: Pancreatic cancer will claim an estimated 47,050 lives in the USA in 2020, with an expected 5 year survival of 10%. Thus there is an urgent need for novel treatment options in this disease. We hypothesize that effective response against pancreatic cancer requires a coordinated approach that orchestrates both the innate and adaptive immune system. We further hypothesize that by orchestrating the activation of the entire immune system, we could accomplish immunogenic cell death with durable responses in this disease. We describe a novel combination immunotherapy protocol of low-dose chemoradiation, cytokine-induced NK and T cell activation via N-803 (an IL-15 cytokine fusion protein), and off-the-shelf PDL1-targeted high-affinity NK cell (PDL1 t-haNK) infusion. Methods: The ongoing QUILT 88 phase II/III, multi-center, three-cohort, open-label, US study (NCT04390399) to evaluate the comparative efficacy and overall safety of standard-of-care chemotherapy versus standard-of-care chemotherapy in combination with aldoxorubicin HCl, N-803, and PD-L1 t-haNK in subjects with locally advanced or metastatic pancreatic cancer. Each treatment setting (ie, first line maintenance, second line, or third line or greater) will be evaluated independently as a separate cohort. Subjects with locally advanced or metastatic pancreatic cancer who have received at least 16 weeks of treatment with gemcitabine plus nab-paclitaxel, and have had either a partial response (PR), CR, or stable disease (SD), will be enrolled into Cohort A to receive first-line maintenance therapy. Subjects who have disease progression on or after receiving first-line treatment with gemcitabine plus nab-paclitaxel or another first-line chemotherapy regimen (eg, FOLFIRINOX), or who have discontinued first-line treatment (eg, due to toxicity or intolerance) will be enrolled into Cohort B to receive second-line therapy randomized to irinotecan-liposome/5FU/LV versus experimental arm. Subjects who have disease progression after receiving at least 2 lines of therapy for pancreatic cancer, will be enrolled into Cohort C to receive third-line or greater treatment. Primary endpoints by cohort are: A) PFS per RECIST V1., B & C) OS. The secondary endpoints include overall response rate, DoR, DCR, OS(cohort A) and QoL by patient-reported outcomes. Clinical trial information: NCT04390399.
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Golla, Heidrun, Kim Dillen, Martin Hellmich, Thomas Dojan, Solveig Ungeheuer, Petra Schmalz, Angelika Staß, et al. "Communication, Coordination, and Security for People with Multiple Sclerosis (COCOS-MS): a randomised phase II clinical trial protocol." BMJ Open 12, no. 1 (January 2022): e049300. http://dx.doi.org/10.1136/bmjopen-2021-049300.
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IntroductionPatients with multiple sclerosis (MS) have complex needs that range from organising one’s everyday life to measures of disease-specific therapy monitoring to palliative care. Patients with MS are likely to depend on multiple healthcare providers and various authorities, which are often difficult to coordinate. Thus, they will probably benefit from comprehensive cross-sectoral coordination of services provided by care and case management (CCM). Though studies have shown that case management improves quality of life (QoL), functional status and reduces service use, such benefits have not yet been investigated in severely affected patients with MS. In this explorative phase ll clinical trial, we evaluated a CCM with long-term, cross-sectoral and outreaching services and, in addition, considered the unit of care (patients and caregivers).Methods and analysisEighty patients with MS and their caregivers will be randomly assigned to either the control (standard care) or the intervention group (standard care plus CCM (for 12 months)). Regular data assessments will be done at baseline and then at 3-month intervals. As primary outcome, we will evaluate patients’ QoL. Secondary outcomes are patients’ treatment-related risk perception, palliative care needs, anxiety/depression, use of healthcare services, caregivers’ burden and QoL, meeting patients’ and caregivers’ needs, and evaluating the CCM intervention. We will also evaluate CCM through individual interviews and focus groups. The sample size calculation is based on a standardised effect of 0.5, and one baseline and four follow-up assessments (with correlation 0.5). Linear mixed models for repeated measures will be applied to analyse changes in quantitative outcomes over time. Multiple imputation approaches are taken to assess the robustness of the results. The explorative approach (phase ll clinical trial) with embedded qualitative research will allow for the development of a final design for a confirmative phase lll trial.Ethics and disseminationThe trial will be conducted under the Declaration of Helsinki and has been approved by the Ethics Commission of Cologne University’s Faculty of Medicine. Trial results will be published in an open-access scientific journal and presented at conferences.Trial registration numberGerman Register for Clinical Studies (DRKS) (DRKS00022771).
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Jones, Robert J., Simon J. Crabb, John D. Chester, Tony Elliott, Robert Anthony Huddart, Alison J. Birtle, Linda Evans, et al. "TOUCAN: A randomised phase II trial of carboplatin and gemcitabine +/- vandetanib in first line treatment of advanced urothelial cell cancer in patients who are not suitable to receive cisplatin." Journal of Clinical Oncology 34, no. 2_suppl (January 10, 2016): 448. http://dx.doi.org/10.1200/jco.2016.34.2_suppl.448.
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448 Background: Whilst cisplatin combination therapy remains the standard of care for patients with advanced urothelial cancers, many patients are unsuitable for cisplatin and go on to receive carboplatin combination therapy. Although responses are frequent, overall outcomes remain poor, and there is a high unmet need for more effective first line treatment. Vandetanib is a well-tolerated, oral inhibitor of vascular and epidermal growth factor receptor tyrosine kinases, both of which are implicated in the pathogenesis of urothelial cancers. Methods: Patients with metastatic or inoperable urothelial cancer who had no prior chemotherapy and were unsuitable for cisplatin were randomly allocated to receive carboplatin (AUC 4.5, day 1) plus gemcitabine (1000mg/m2, days 1 and 8) plus either vandetanib (100mg od, days 1-21) (GCV) or matching placebo (GCP) in 21-day cycles up to a total of 6 cycles. Treatment allocation was double-blind. There was a planned safety review after the first 40 patients had received at least one cycle. The primary endpoint was progression free survival (PFS). Sample size (n=82) was calculated using a one-sided alpha of 0.2 and power 80% to detect a HR of 0.65 for PFS. We present the final efficacy results. The trial was coordinated by the Wales Cancer Trials Unit at Cardiff University and funded by Cancer Research UK (CRUK/09/024) and AstraZeneca. Results: Of 82 patients, 40 received GCV. 62 (76%) had a bladder primary, and 56 (68%) had poor renal function. The arms were well balanced except for age > 75 (13 (16%) GCV, 23 (28%) GCP). Median PFS was 8.5 months (m) (95% CI 6.0, 9.7) and 8.8 m (5.8, 9.0) for GCV and GCP respectively (adjusted hazard ratio (HR) 0.93 (0.50, 1.71), P=0.89). Overall survival was 10.8 m (8.0, 13.0) and 13.8 m (11.1, 16.6) for GCV and GCP respectively (adjusted HR 1.38 (0.77, 2.46), P=0.24). Response rates were 50% (n=20) and 55% (n=23) for GCV and GCP. All-grade adverse events were similar but there were significantly more grade 3+ events in the GCV arm. Conclusion: Vandetanib did not improve efficacy of chemotherapy but increased toxicity in advanced urothelial cancer not suitable for cisplatin. Clinical trial information: 68146831.
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Kho, Michelle E., Mark Duffett, France J. Clarke, Melissa Shears, Alexander J. Molloy, and Deborah J. Cook. "Video-augmented vs standard consent in an early ICU cycling feasibility trial: a randomized embedded recruitment trial." F1000Research 9 (January 24, 2020): 45. http://dx.doi.org/10.12688/f1000research.21750.1.
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Background: In a trial of early in-bed cycling in critically ill patients, a video demonstrating use of the cycle in addition to verbal description may improve satisfaction with the informed consent process for all persons involved. Methods: A convenience sample of in-person consent encounters for enrolment in TryCYCLE (NCT01885442), a 33-patient pilot study of in-bed cycling with mechanically ventilated patients in an intensive care unit, were recruited. In this study within a trial, using concealed allocation, we randomized consent encounters to a Video or Standard consent approach. Those in the Video group viewed a 2-minute video of a model using in-bed cycling plus the routine verbal description of the study. The Standard group received the routine verbal description only. Patients and/or substitute decision makers (SDMs) were blinded to the study purpose. After each encounter, patients and/or SDMs and the research coordinator submitted written satisfaction and comfort ratings using 7-point scales (higher scores better). We documented consent outcomes and analyzed between group differences with independent group t-tests. Results: We randomized 14 encounters (6 Video, 8 Standard). Ten completed questionnaires (5 in each group) demonstrated no difference in patient and/or SDM satisfaction or comfort between Video or Standard (mean [standard deviation] Satisfaction: 6.8[0.45] vs. 7.0[0] vs. p=0.37; Comfort: 7.0[0] vs. 7.0[0], p>0.99). The research coordinator evaluated all randomized encounters, with no differences between Video or Standard (Satisfaction: 7.0[0] vs. 6.9[0.35], p=0.41; Comfort: 6.7[0.52] vs. 6.9[0.35], p=0.39). All 14 consent encounters enrolled in TryCYCLE. Conclusions: Patient and/or SDM satisfaction and comfort with consent was very high for both the Video and Standard approaches. Further research, including use of videos to portray different study interventions, is needed, including analysis of patient and/or SDM satisfaction, comfort, comprehension, and consent rates. Registration for host trial: ClinicalTrials.gov, NCT01885442, registered on June 25, 2013
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W Harvey, Peter, and Peter J McDonald. "The science of the COAG coordinated care trials." Australian Journal of Primary Health 9, no. 3 (2003): 109. http://dx.doi.org/10.1071/py03033.
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Objectives: To explicate the organisational change agenda of the COAG coordinated care trials within the Australian health system and to illuminate the role of science in this process. Methods and Results: This article briefly outlines the COAG coordinated care trial aims and the effect of the trial as a change initiative in rural South Australia. It is proposed that although the formal trial outcomes are still not clear, the trial had significant impact upon health service delivery in some sites. The trial involved standard research methods with control and intervention groups and with key hypotheses being tested to compare the costs and service utilization profile of intervention and control groups. Formal results indicate that costs were not significantly different between intervention and control groups across all sites, but that the trial, nonetheless, had a powerful impact on the attitude and behaviours of service providers in the rural trial on Eyre Peninsula in particular. Some of the key structural changes now in place are outlined. Conclusions: The COAG trial has had many and varied impacts upon those organisations and individual providers involved with it. It is argued here that since successive initiatives had been implemented before final evaluation results were published, other agendas were served by the trial apart from those of standard scientific research and hypothesis testing. That is, the main impact of the coordinated care trial in Eyre Region at least has been change by stealth, and not through scientific research and demonstration. Implications: The COAG trials have set in train a series of structural and procedural changes in the methods of delivery and management of primary health care systems; changes that are embodied in the Enhanced Primary Care packages (EPC) and other initiatives recently introduced by the Commonwealth Government. These changes have occurred and are occurring across the system without formal evidence as to their efficacy, suggesting that other financial motives are driving these new approaches apart from the goal of improving health outcomes for consumers. Also, if science is to be used in this way to drive policy and procedural change ahead of actual outcome evidence, it is important that we examine the more subtle agendas of such research projects in future if the integrity of the scientific method is to be maintained. The occurrence of such phenomena questions the very foundation of scientific endeavour and weakens the application of scientific principles in the arena of social and political science.
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Gordon, Leo I., Fanxing Hong, Richard I. Fisher, Nancy L. Bartlett, Joseph M. Connors, Randy D. Gascoyne, Henry Wagner, et al. "A Randomized Phase III Trial of ABVD Vs. Stanford V +/− Radiation Therapy In Locally Extensive and Advanced Stage Hodgkin's Lymphoma: An Intergroup Study Coordinated by the Eastern Cooperatve Oncology Group (E2496)." Blood 116, no. 21 (November 19, 2010): 415. http://dx.doi.org/10.1182/blood.v116.21.415.415.
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Abstract Abstract 415 Background: The ability to cure patients (pts) with advanced Hodgkin's Lymphoma (HL) with combination chemotherapy (CC) (MOPP and variants, ABVD and variants) represented a major milestone in oncology research, and CC became a paradigm for other malignancies. Further, the rationale for combined modality therapy (CMT) (radiation (RT) and CC) in HL evolved based on the high frequency of relapse in initially involved sites. As response rates and survival improved, newer treatments such as the combined modality Stanford V regimen were developed to shorten the duration of chemotherapy, add RT to sites of disease and reduce toxicity while maintaining or improving the cure rate. Indeed, the Stanford V regimen was tested and validated in a Phase II co-operative group trial (E1492) (J Clin Oncol 2000; 18:972). In order to investigate this approach against “standard” therapy, we conducted a randomized Phase III Intergroup trial of ABVD vs. the Stanford V regimen for patients with locally extensive or advanced HL. Objectives: The trial was designed to detect a 33% reduction in the failure free survival (FFS) hazard rate with Stanford V compared with ABVD, which corresponds to a difference in five-year FFS of 64% vs. 74%. Method: Patients with locally extensive (defined as clinical Ann Arbor Stage I-IIA/B and bulky mediastinal disease (BMD) (mass > 1/3 maximum intrathoracic diameter on standing postero-anterior chest x-ray or >/−10 cm on computerized tomography) or advanced (Ann Arbor Stage III or IV) HL were randomized to receive either ABVD × 6–8 cycles (C) (51% had 6 C, 35% had 8 C, 14% had <6 C) + 36 Gy (only in pts with BMD) or Stanford V × 12 weeks (95% had 12 weeks) + 36 Gy (for sites >5cm or for macroscopic splenic disease). The log-rank test was used to compare FFS for all eligible patients stratified on extent of disease (locally extensive vs. advanced), and number of International Prognostic Factor Project (IPFP) risk factors (0–2 vs. 3–7). An extended Cox model was also used to address non-proportional hazard between the two arms. Results: 854 pts enrolled from April, 1999 to June, 2006 and 812 were eligible for analysis. 404 pts were randomized to ABVD and 408 to Stanford V. Median age was 33 yrs in both arms (range 16–83). 53% were men and 47% women; 4% had Stage I, 31% had Stage II, 39% had Stage III and 25% had Stage IV disease by Ann Arbor criteria. 35% of pts on ABVD and 35% on Stanford V had BMD. Three % of pts had nodular lymphocyte predominant HL, 77% of pts had nodular sclerosis HL, 14% had mixed cell HL. Age, stage, pathology and risk factors (0–2 vs. 3–7) were similar in both arms. In total, 65% were IPFP score 0–2 and 33% were 3–6. Response rate. There was no difference in response rates (RR) between the two arms (ABVD=72% CR+ CCR, 7.7% PR, 7.9% SD; Stanford V= 69 % CR +CCR, 7% PR and 10 % SD. 8% were not evaluable for response on ABVD and 9% on Stanford V. Toxicity was similar in both groups. The most frequent Grade 3 + 4 toxicity was neutropenia, and was similar between the 2 groups (76% Grade 3 + 4 in ABVD and 70% Grade 3+ 4 in Stanford V). Grade 5 toxicity was <1% in both groups. There was, however, more Grade 3 lymphopenia in Stanford V (78% vs. 42%, p< 0.0001) and more Grade 3 +4 sensory neuropathy in Stanford V (10%) than in ABVD (3%) (p< 0.0001). A total of 26 second primary cancers developed, 12 after ABVD and 14 after Stanford V (p=NS). FFS and OS. For 812 eligible patients, with a median follow up of 5.25 years, 5-year FFS was 73% for ABVD and 71% for Stanford V (p=0.29 by log rank) (Figure left); 5-year OS was 88% for ABVD and 87% for Stanford V (p=0.87 by log-rank, HR=0.97, 95% CI: 0.65 to 1.44) (Figure right) indicating no significant difference in either FFS or OS between the 2 arms. Conclusion: In the largest Phase III intergroup trial of HL in North America, there was no significant difference in RR, FFS, OS, and 5-year toxicity when ABVD (+ RT for BMD) is compared with Stanford V (+RT for nodal sites >5 cm and macroscopic splenic disease). There was more Grade 3 lymphopenia (p< 0.0001) and more Grade 3 + 4 sensory neuropathy (p< 0.0001) on Stanford V. Thus ABVD (plus RT for BMD) remains the standard of care because Stanford V did not meet the objective of 33% improvement in FFS. For some patients, Stanford V, when given as described with RT, remains an acceptable alternative. Disclosures: Friedberg: Genentech: Honoraria. Blum:Seattle Genetics: Research Funding; Novartis: Research Funding; Celgene: Research Funding. Horning:Genentech: Employment.
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McDonald, Paula K., C. Ann Winkle, and Deborah Askew. "Evaluation of Academic Detailing Within a Coordinated Care Trial." Journal of Pharmacy Practice and Research 33, no. 2 (June 2003): 114–16. http://dx.doi.org/10.1002/jppr2003332114.
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Perkins, David, Alan Owen, David Cromwell, Linda Adamson, Kathy Eagar, Karen Quinset, and Janette Green. "The Illawarra Coordinated Care Trial: better outcomes with existing resources?" Australian Health Review 24, no. 2 (2001): 172. http://dx.doi.org/10.1071/ah010172.
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The Illawarra Coordinated Care Trial was one of nine Australian trials undertaken to see whether different modelsof coordinated care could improve the health of people with multiple service needs within existing resources. This papersummarises the findings of an extensive local evaluation and discusses the impact of the trial on clients and serviceproviders. It examines the main findings related to the principal trial hypothesis and points to lessons that mightinform the next round of trials.
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Wiktorzak, Katarzyna, Anna Kozieł, Sylwia I. Szafraniec-Buryło, and Andrzej Śliwczyński. "How to design and implement integrated care programmes: Coordinated care models and Primary Health Care PLUS project in Poland." International Journal of Integrated Care 18, s2 (October 23, 2018): 397. http://dx.doi.org/10.5334/ijic.s2397.
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Wiktorzak, Katarzyna, Anna Kozieł, Sylwia I. Szafraniec-Buryło, and Andrzej Śliwczyński. "How to design and implement integrated care programmes: Coordinated care models and Primary Health Care PLUS project in Poland." International Journal of Integrated Care 18, s2 (October 23, 2018): 397. http://dx.doi.org/10.5334/ijic.s2937.
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Rowntree, Clare J., Amy A. Kirkwood, Laura Clifton-Hadley, Nadine Farah, Marc R. Mansour, Jiaull Hussain, David I. Marks, et al. "First Analysis of the UKALL14 Randomized Trial to Determine Whether the Addition of Nelarabine to Standard Chemotherapy Improves Event Free Survival in Adults with T-Cell Acute Lymphoblastic Leukaemia (CRUK/09/006)." Blood 138, Supplement 1 (November 5, 2021): 366. http://dx.doi.org/10.1182/blood-2021-152355.
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Abstract Background: Between April 2012 and July 2018, adult patients aged 25-65 years with newly diagnosed T-cell acute lymphoblastic leukaemia (T-ALL) in 48 UK centres were randomised at trial entry to receive standard of care (SOC) ALL induction phases I and II chemotherapy with or without the addition of single-agent nelarabine. Nelarabine 1.5 g/m 2 was given on days 1, 3 and 5 following the second phase of induction. The trial had 86% power to detect a 25% improvement (50-75%) in 3-year event free survival (hazard ratio [HR]=0.42, events: relapse and death) and a two-sided alpha 0.05. Early T-cell progenitors express high levels of SAMHD1, a gene recently shown to mediate resistance to nelarabine(Rothenburger et al, Commun Biol, 2020). We retrospectively assessed diagnostic samples for their level of differentiation arrest through analysis of the TCRg locus. Here, the most immature cases are detected through absence of biallelic TCRg deletion (ABD)(Farah et al, Haematologica, 2018). Results were correlated with survival outcomes. Results: 144 eligible patients were recruited, of whom 75 were randomised to SOC and 69 to SOC plus nelarabine (SOC+N). Baseline characteristics were balanced for factors including age (median age 38 years), presenting white cell count and performance status with a slightly greater proportion with cytogenetic high-risk factors in the SOC arm (8.5% vs 20%).The complete remission (CR) rate following induction phase I and II was 90.7% in the SOC arm and 87.0% in the SOC+N arm. The rate of severe adverse events and non-relapse mortality did not differ between the arms. There was no increase in grade 3-4 neurotoxicity reported in patients who received nelarabine with 6 events (9.0%) reported in the SOC arm during phase II induction and 7 events (11.9%) in the SOC+N arm. There were no deaths reported from neurotoxicity in either arm. Of those randomised at diagnosis to receive SOC+N, 48 (71.0%) actually received the agent, as those with persistent therapy-related toxicities were excluded. Forty-three patients (62.3%) received all 3 planned doses. Analysis is by intention-to-treat. At a median follow up of 51.9 months, 3-year EFS was 57.0% (95% confidence interval [CI] 44.7%-67.5%) in the SOC arm vs. 61.7% (48.7-72.4) in the SOC+N arm; HR 0.88 (0.52-1.46; p=0.61) (fig 1A). Overall survival (OS) at 3 years was 61.5% (49-71.8) SOC vs 65.7% (52.6-76) SOC+N; HR 0.91 (0.53-1.56; p=0.73). 133 patients achieved CR and were assessable for relapse; relapse rates (RR) at 3 years were similar, 29.1% (19.7-41.9) in the SOC arm vs 28.0% (18.4-41.3) in the SOC+N arm; HR 0.97 (0.48-1.92; p=0.91). An "as-treated" analysis did not change conclusions. Outcomes were improved compared to our prior trial, UKALL 12 despite a higher median age in UKALL 14; 5-year OS and RR 58.0% (48.3 - 66.5) and 28.7% (21.6 - 37.6) vs 48.0% (42- 53%) and 42.0% (36-47%). ABD status at diagnosis was examined in 108 patients. Of these, 48 were non-ABD, 46 ABD and 14 indeterminate. Patients with ABD were less likely to be MRD negative post-induction (26.0 vs 58.0%, p=0.001) and had a significantly higher relapse rate at 3 years compared to patients without ABD (fig 1B), 42.5% (29.0 - 59.2 ) vs 17.4% (9.1 - 31.8 ); HR 2.59 (1.12 - 5.96, p=0.02). This result held when adjusted for other baseline risk factors. The proportion of patients receiving allogeneic transplantation was similar (58.8% non-ABD/56.9% ABD, p = 0.84). The interaction with treatment arm was not significant (p=0.46). Clinical implications: Three doses of nelarabine added to standard chemotherapy in the treatment of adult T-cell ALL patients was well tolerated. However, there was no demonstrable EFS or OS benefit seen with the addition of nelarabine. Survival outcomes for patients with T-cell ALL in the UKALL 14 trial were improved compared to UKALL12 despite the older age of patients in UKALL14 suggesting that other protocol factors had a positive effect on outcomes. The paediatric COG AALL0434 study showed a DFS benefit for nelarabine given as six 5-day courses. It is possible that too few doses were given in UKALL14 to show benefit. We identified ABD as an independent negative prognostic factor within this cohort of adult patients. Patients with T ALL and ABD had over twice the risk of relapse, suggesting that they should be considered high-risk in future studies. We were not able to demonstrate a benefit of nelarabine according to ABD status. Figure 1 Figure 1. Disclosures Clifton-Hadley: Millennium pharmaceutics inc.: Other: The haematology team at the CTC has received funding (which in part pays staff salary) to Sponsor and coordinate clinical trials.; Pfizer: Other: The haematology team at the CTC has received funding (which in part pays staff salary) to Sponsor and coordinate clinical trials.; Janssen-Cilag: Other: The haematology team at the CTC has received funding (which in part pays staff salary) to Sponsor and coordinate clinical trials.; Merck Sharp and Dohme: Other: The haematology team at the CTC has received funding (which in part pays staff salary) to Sponsor and coordinate clinical trials.; Amgen: Other: The haematology team at the CTC has received funding (which in part pays staff salary) to Sponsor and coordinate clinical trials.; Celgene: Other: The haematology team at the CTC has received funding (which in part pays staff salary) to Sponsor and coordinate clinical trials.; Bristol-Myers Squibb Pharmaceuticals Ltd..: Other: The haematology team at the CTC has received funding (which in part pays staff salary) to Sponsor and coordinate clinical trials.. Mansour: Janssen: Consultancy; Astellas: Consultancy, Honoraria. Fielding: servier: Research Funding; Novartis: Consultancy; Amgen: Consultancy. OffLabel Disclosure: Nelarabine for denovo ALL
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Gardner, Karen, and Beverly Sibthorpe. "Impediments to change in an Australian trial of coordinated care." Journal of Health Services Research & Policy 7, no. 1_suppl (July 2002): 2–7. http://dx.doi.org/10.1258/135581902320176403.
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Objectives To identify impediments to change at the local level in an Australian trial of coordinated care. Methods Qualitative data were collected from in-depth interviews with key stakeholders, analysis of policy and other documents and the observation of trial processes. We developed an analytical framework that included four domains: agreeing trial goals and objectives; overcoming the financial barriers to producing effective care; reducing costs; and improving continuity of care. In each of these domains, we examined the strategies and processes adopted by the trial as well as the perceptions, actions and reactions of the various stakeholders to the evolving model. Results The trial had mixed success in implementing its key strategies in each of the four domains. Stakeholders did not fully endorse the trial&s key goals and strategies, general practitioners were unable to become effective purchasers, increased gatekeeping was never fully realised, cost-saving strategies were not taken up and improvements in continuity of care were impeded by limited provider networks and general practitioner reluctance to collaborate with other providers. Thus the system had some key features of a coordinated care model but none of the qualities that were needed to operationalise them. Conclusions The trial&s approach to coordinating care and its use of market mechanisms to remove the financial barriers to effective care were insufficient for motivating behaviour change in the context of a system that is structured by powerful social processes and relationships.
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Matchar, David B., Linda Harpole, Gregory P. Samsa, Annette Jurgelski, Richard B. Lipton, Stephen D. Silberstein, William Young, Shashidhar Kori, and Andrew Blumenfeld. "The Headache Management Trial: A Randomized Study of Coordinated Care." Headache: The Journal of Head and Face Pain 48, no. 9 (October 2008): 1294–310. http://dx.doi.org/10.1111/j.1526-4610.2007.01148.x.
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Groenvold, Mogens, Morten Aagaard Petersen, Anette Damkier, Mette Asbjoern Neergaard, Jan Bjoern Nielsen, Lise Pedersen, Per Sjøgren, et al. "Randomised clinical trial of early specialist palliative care plus standard care versus standard care alone in patients with advanced cancer: The Danish Palliative Care Trial." Palliative Medicine 31, no. 9 (May 12, 2017): 814–24. http://dx.doi.org/10.1177/0269216317705100.
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Background: Beneficial effects of early palliative care have been found in advanced cancer, but the evidence is not unequivocal. Aim: To investigate the effect of early specialist palliative care among advanced cancer patients identified in oncology departments. Setting/participants: The Danish Palliative Care Trial (DanPaCT) (ClinicalTrials.gov NCT01348048) is a multicentre randomised clinical trial comparing early referral to a specialist palliative care team plus standard care versus standard care alone. The planned sample size was 300. At five oncology departments, consecutive patients with advanced cancer were screened for palliative needs. Patients with scores exceeding a predefined threshold for problems with physical, emotional or role function, or nausea/vomiting, pain, dyspnoea or lack of appetite according to the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) were eligible. The primary outcome was the change in each patient’s primary need (the most severe of the seven QLQ-C30 scales) at 3- and 8-week follow-up (0–100 scale). Five sensitivity analyses were conducted. Secondary outcomes were change in the seven QLQ-C30 scales and survival. Results: Totally 145 patients were randomised to early specialist palliative care versus 152 to standard care. Early specialist palliative care showed no effect on the primary outcome of change in primary need (−4.9 points (95% confidence interval −11.3 to +1.5 points); p = 0.14). The sensitivity analyses showed similar results. Analyses of the secondary outcomes, including survival, also showed no differences, maybe with the exception of nausea/vomiting where early specialist palliative care might have had a beneficial effect. Conclusion: We did not observe beneficial or harmful effects of early specialist palliative care, but important beneficial effects cannot be excluded.
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Kumar, D. S. "Coordinated care consisting of cognitive behavioural therapy plus medication improves panic disorder." Evidence-Based Mental Health 8, no. 4 (November 1, 2005): 110. http://dx.doi.org/10.1136/ebmh.8.4.110.
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Mills, Peter D., and Peter W. Harvey. "BEYOND COMMUNITY-BASED DIABETES MANAGEMENT AND THE COAG COORDINATED CARE TRIAL." Australian Journal of Rural Health 11, no. 3 (June 2003): 131–37. http://dx.doi.org/10.1111/j.1440-1584.2003.tb00523.x.
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Mills, Peter D., and Peter W. Harvey. "Beyond community-based diabetes management and the COAG coordinated care trial." Australian Journal of Rural Health 11, no. 3 (June 2003): 131–37. http://dx.doi.org/10.1046/j.1440-1584.2003.00508.x.
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Brubaker, Linda, J. Eric Jelovsek, Emily S. Lukacz, Sunil Balgobin, Alicia Ballard, Alison C. Weidner, Marie G. Gantz, Ryan Whitworth, and Donna Mazloomdoost. "Recruitment and retention: A randomized controlled trial of video-enhanced versus standard consent processes within the E-OPTIMAL study." Clinical Trials 16, no. 5 (July 26, 2019): 481–89. http://dx.doi.org/10.1177/1740774519865541.
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Background/aims: In this study, we compared two research consent techniques: a standardized video plus usual consent and usual consent alone. Methods: Individuals who completed 24-month outcomes (completers) in the Operations and Pelvic Muscle Training in the Management of Apical Support Loss study were invited to participate in an extended, longitudinal follow-up study (extended Operations and Pelvic Muscle Training in the Management of Apical Support Loss). Potential participants who were (1) able to provide consent and (2) not in long-term care facilities were randomized 1:1 to a standardized video detailing the importance of long-term follow-up studies of pelvic floor disorders followed by the usual institutional consent process versus the usual consent process alone. Randomization, stratified by site, used randomly permuted blocks. The primary outcome was the proportion of participants who enrolled in the extended study and completed data collection events 5 years after surgery. Secondary outcomes included the proportion enrolled in the extended study, completion of follow-up at each study year, completion of data collection points, completion of in-person visits, and completion of quality of life calls. Motivation and barriers to enrollment (study-level and personal-level) and satisfaction with the study consent process were measured by questionnaire prior to recruitment into extended Operations and Pelvic Muscle Training in the Management of Apical Support Loss. Groups were compared using an intention-to-treat principle, using unadjusted Student’s t-test (continuous) and chi-square or Fisher’s exact (categorical) test. A sample size of 340 (170/group) was estimated to detect a 15% difference in enrollment and study completion between groups with p < 0.05. Results: Of the 327 Operations and Pelvic Muscle Training in the Management of Apical Support Loss completers, 305 were randomized to the consent process study (153 video vs 152 no video). Groups were similar in demographics, surgical treatment, and outcomes. The overall rate of extended study enrollment was high, without significant differences between groups (video 92.8% vs no video 94.1%, p = 0.65). There were no significant differences in the primary outcome (video 79.1% vs no video 75.7%, p = 0.47) or in any secondary outcomes. Being “very satisfied” overall with study information (97.7% vs 88.5%, p = 0.01); “strong agreement” for feeling informed about the study (81.3% vs 70.8%, p = 0.06), understanding the study purpose (83.6% vs 71.0%, p = 0.02), nature and extent (82.8% vs 70.2%, p = 0.02), and potential societal benefits (82.8% vs 67.9%, p = 0.01); and research coordinator/study nurse relationship being “very important” (72.7% vs 63.4%, p = 0.03) were better in the video compared to the no video consent group. Conclusion: The extended study had high enrollment; most participants completed most study tasks during the 3-year observational extension, regardless of the use of video to augment research consent. The video was associated with a higher proportion of participants reporting improved study understanding and relationship with study personnel.
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Richards, D. A., K. Lovell, S. Gilbody, L. Gask, D. Torgerson, M. Barkham, M. Bland, et al. "Collaborative care for depression in UK primary care: a randomized controlled trial." Psychological Medicine 38, no. 2 (September 6, 2007): 279–87. http://dx.doi.org/10.1017/s0033291707001365.
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BackgroundCollaborative care is an effective intervention for depression which includes both organizational and patient-level intervention components. The effect in the UK is unknown, as is whether cluster- or patient-randomization would be the most appropriate design for a Phase III clinical trial.MethodWe undertook a Phase II patient-level randomized controlled trial in primary care, nested within a cluster-randomized trial. Depressed participants were randomized to ‘collaborative care’ – case manager-coordinated medication support and brief psychological treatment, enhanced specialist and GP communication – or a usual care control. The primary outcome was symptoms of depression (PHQ-9).ResultsWe recruited 114 participants, 41 to the intervention group, 38 to the patient randomized control group and 35 to the cluster-randomized control group. For the intervention compared to the cluster control the PHQ-9 effect size was 0.63 (95% CI 0.18–1.07). There was evidence of substantial contamination between intervention and patient-randomized control participants with less difference between the intervention group and patient-randomized control group (−2.99, 95% CI −7.56 to 1.58, p=0.186) than between the intervention and cluster-randomized control group (−4.64, 95% CI −7.93 to −1.35, p=0.008). The intra-class correlation coefficient for our primary outcome was 0.06 (95% CI 0.00–0.32).ConclusionsCollaborative care is a potentially powerful organizational intervention for improving depression treatment in UK primary care, the effect of which is probably partly mediated through the organizational aspects of the intervention. A large Phase III cluster-randomized trial is required to provide the most methodologically accurate test of these initial encouraging findings.
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Johnsen, Anna Thit, Morten Aagaard Petersen, Per Sjøgren, Lise Pedersen, Mette Asbjoern Neergaard, Anette Damkier, Christian Gluud, et al. "Exploratory analyses of the Danish Palliative Care Trial (DanPaCT): a randomized trial of early specialized palliative care plus standard care versus standard care in advanced cancer patients." Supportive Care in Cancer 28, no. 5 (August 13, 2019): 2145–55. http://dx.doi.org/10.1007/s00520-019-05021-7.
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Plant, Natalie A., Patrick J. Kelly, Stephen R. Leeder, Mario D'Souza, Kylie‐Ann Mallitt, Tim Usherwood, Stephen Jan, et al. "Coordinated care versus standard care in hospital admissions of people with chronic illness: a randomised controlled trial." Medical Journal of Australia 203, no. 1 (July 2015): 33–38. http://dx.doi.org/10.5694/mja14.01049.
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Battersby, Malcolm, Peter McDonald, Rodney Pearce, Barry Tolchard, and Ken Allen. "The changing attitudes of health professionals and consumers towards a coordinated care trial - SA HealthPlus." Australian Health Review 24, no. 2 (2001): 172. http://dx.doi.org/10.1071/ah010172a.
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The national coordinated care trials have been a vehicle for health reform in Australia, driven by escalating healthcare costs and projections of an ageing population. The first round of trials conducted between 1997 and 1999 set thetrials a challenge to reduce financial and system barriers to enable health professionals in all sectors and consumers todevelop service delivery models which would give better outcomes for patients within existing resources. As part of achange management strategy, the developers of the SA HealthPlus trial assessed the attitudes of health professionalsand consumers involved in designing the projects which made up the larger trial, prior to trial development and twelvemonths later. This paper reports on the results of the survey and how initial enthusiasm gave way to appropriateanxiety as the complexities of creating a new system of care from reactive to prospective patient centred care planning,became a reality. The survey enabled trial developers to show evidence of acceptability for the new model of care andidentify areas of concern and appropriate strategies for the project teams. This type of survey and the issues identifiedmay be of benefit to the second round coordinated care trials and health regions aiming to initiate coordinated careprograms.
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Patterson, Elizabeth, Heidi Muenchberger, and Elizabeth Kendall. "The role of practice nurses in coordinated care of people with chronic and complex conditions." Australian Health Review 31, no. 2 (2007): 231. http://dx.doi.org/10.1071/ah070231.
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General practice in Australia must cope with growing numbers of individuals with chronic and complex needs. The Australian Government has recognised the need to reform the primary health care sector to address this issue, with recent initiatives, such as coordinated care. The overall goal of coordinated care at a national level is to facilitate integrated care for people with chronic and complex conditions, by enhancing collaborative partnerships among general practitioners, primary health care providers, community service providers and clients. Interestingly, practice nurses (PNs) have not been identified as key stakeholders in the coordinated care service delivery model in Australia. In contrast, an expanded role for PNs has been in place in the United Kingdom and New Zealand for some time. This paper is based on focus group discussions with Australian PNs who have had a range of experiences in coordinated care models. The study identifies an important role for PNs, suggesting trial of a variety of models of coordinated care that include PNs in chronic disease management process.
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d, A. Hear, E. Kaluc y, D. Richardso n, M. W. Battersby, P. Frit h, and C. McGowa n. "An Evaluation of the Care Planning Process in Coordinated Care Trials: What Difference Do Care Plans Make to Service Provision?" Australian Journal of Primary Health 8, no. 1 (2002): 52. http://dx.doi.org/10.1071/py02008.
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Care planning was an integral part of the SA HealthPlus Coordinated Care trial. This paper reports on the usefulness of care planning as a reminder system to GPs and patients in ensuring that chronically ill patients received planned services. Two thousand and seventy one (2071) intervention patients and 1317 control patients were eligible for the study. Data were collected from all sources recording the delivery of medical services, and the percentage of intervention and control patients receiving the service was compared. Two planned services - lipids tests and bowel cancer screening - were used in the analyses. A higher percentage of intervention patients than control patients received the lipid test and the bowel cancer screening test. Care planning has proved a useful means of increasing the delivery of at least two best practice services to a needy group of people with chronic illnesses.
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Wootton, Richard, Helen Gramotnev, and David Hailey. "Telephone-supported care coordination in an Australian veterans population: a randomized controlled trial." Journal of Telemedicine and Telecare 16, no. 2 (December 11, 2009): 57–62. http://dx.doi.org/10.1258/jtt.2009.090408.
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An evaluation was undertaken on the effectiveness and efficiency of care coordination in delivering health services to Australian veterans with chronic or complex medical conditions requiring multidisciplinary care and who had moderate to high care needs. The veterans participated in a randomized controlled trial (RCT) supported by the Department of Veterans' Affairs. For evaluation of the RCT, information on cost of care and quality of life (QOL) was collected before the commencement of coordinated care and at follow-up after 12 months. Of 525 veterans who were recruited, 481 were surveyed at baseline (243 in the intervention group and 238 controls). At follow-up, 421 were surveyed (213 intervention and 208 controls). There were no significant differences between the coordinated care and control groups of veterans in costs of care or in QOL measurements using the SF-12 Health Survey and the EuroQol Group EQ-5D. These findings are consistent with those reported in earlier studies which suggest that benefits from care coordination programmes may take some time to emerge.
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Erkkilä, Jaakko, Marko Punkanen, Jörg Fachner, Esa Ala-Ruona, Inga Pöntiö, Mari Tervaniemi, Mauno Vanhala, and Christian Gold. "Individual music therapy for depression: randomised controlled trial." British Journal of Psychiatry 199, no. 2 (August 2011): 132–39. http://dx.doi.org/10.1192/bjp.bp.110.085431.
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BackgroundMusic therapy has previously been found to be effective in the treatment of depression but the studies have been methodologically insufficient and lacking in clarity about the clinical model employed.AimsTo determine the efficacy of music therapy added to standard care compared with standard care only in the treatment of depression among working-age people.MethodParticipants (n= 79) with an ICD–10 diagnosis of depression were randomised to receive individual music therapy plus standard care (20 bi-weekly sessions) or standard care only, and followed up at baseline, at 3 months (after intervention) and at 6 months. Clinical measures included depression, anxiety, general functioning, quality of life and alexithymia. Trial registration: ISRCTN84185937.ResultsParticipants receiving music therapy plus standard care showed greater improvement than those receiving standard care only in depression symptoms (mean difference 4.65, 95% CI 0.59 to 8.70), anxiety symptoms (1.82, 95% CI 0.09 to 3.55) and general functioning (–4.58, 95% CI −8.93 to −0.24) at 3-month follow-up. The response rate was significantly higher for the music therapy plus standard care group than for the standard care only group (odds ratio 2.96, 95% CI 1.01 to 9.02).ConclusionsIndividual music therapy combined with standard care is effective for depression among working-age people with depression. The results of this study along with the previous research indicate that music therapy with its specific qualities is a valuable enhancement to established treatment practices.
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Nikseresht, Tahere, Mansour Rezaei, and Alireza Khatony. "The Effect of Three Eye Care Methods on the Severity of Lagophthalmos in Intensive Care Patients: A Randomized Controlled Clinical Trial." Journal of Ophthalmology 2021 (September 15, 2021): 1–7. http://dx.doi.org/10.1155/2021/6348987.
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Background. Patients admitted to intensive care units are exposed to a variety of eye injuries such as lagophthalmos, which can lead to blindness. There is conflicting evidence regarding the effectiveness of different eye protection methods, and evaluations are ongoing. Therefore, this study was performed to compare the effect of “polyethylene cover,” “polyethylene cover plus artificial tear drops,” and “polyethylene cover plus Lubratex eye ointment” on the severity of lagophthalmos. Methods. A total of 156 patients connected to ventilators were included in this clinical trial using the convenience sampling method. They were randomly divided into three groups: “polyethylene cover,” polyethylene cover plus artificial tear drops,” and “polyethylene cover plus Lubratex eye ointment.” In each group, one eye was regarded as control and the other eye as intervention. The control eye received routine interventions, including washing with normal saline. The eyes were examined daily by an ophthalmologist for 5 days for the occurrence of lagophthalmos. Results. There was no statistically significant difference in the severity of lagophthalmos among the three groups “polyethylene cover,” “polyethylene cover plus artificial tear drop,” and “polyethylene cover plus Lubratex eye ointment.” However, clinically the severity of lagophthalmos was lower in the “polyethylene cover plus artificial tear drops” group than in the other two groups. Conclusion. The results showed that the combination of polyethylene cover and artificial tears drops can be clinically effective in reducing the severity of lagophthalmos. Therefore, the use of this method is recommended for patients admitted to the intensive care unit. Similar studies are recommended.
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Kerr, Megan, Janine Cramond, and Maggie Scott. "Service Coordinators in the NECC Trial: An RDNS perspective." Australian Journal of Primary Health 6, no. 4 (2000): 104. http://dx.doi.org/10.1071/py00042.
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The Royal District Nursing Service (RDNS) became involved in the North-Eastern Coordinated Care Trial in October 1997. The purpose of this was to assist the trial in exploring the hypothesis, that for people with chronic or complex care needs, care coordination will provide improved outcomes at the same or a reduced cost. There are a number of areas, which help to clarify the process involved in the trial and the benefits for clients: how the coordinators were chosen; the role of the Care and Service Coordinators: benefits experienced by the professionals; benefits experienced by clients: and discussion points.
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Kitto, Simon. "Negotiating Medical Dominance: The Social Construction of the Care Coordinator within the Tasmanian Coordinated Care Trials." Australian Journal of Primary Health 7, no. 2 (2001): 62. http://dx.doi.org/10.1071/py01036.
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State and corporate induced changes to health care systems are occurring globally. These changes are altering the environment, which previously supported the medical profession's dominance over all health matters. Health care occupations, in conjunction with systemic health care changes, also threaten the autonomy of general practitioners through new opportunistic attempts to expand their occupational territory. Using a symbolic interactionist approach in tandem with Bucher's natural history framework to trace the emergence of an occupation, this paper analyses the social processes involved in the construction of the care coordinator occupation within the context of the Coordinated Care Trial in Tasmania. An analysis of both the occupational encroachment and defensive strategies employed by government health agencies, general practitioners, nurses, and pharmacists during the construction of the position description of the care coordinator is undertaken. Specifically, the focus of this paper is on how the general practitioners acted to retain their preeminent position within the health care system when facing a dual challenge from above (the state) and below (nursing, pharmacy).
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Butler, Christopher C., Alike W. van der Velden, Emily Bongard, Benjamin R. Saville, Jane Holmes, Samuel Coenen, Johanna Cook, et al. "Oseltamivir plus usual care versus usual care for influenza-like illness in primary care: an open-label, pragmatic, randomised controlled trial." Lancet 395, no. 10217 (January 2020): 42–52. http://dx.doi.org/10.1016/s0140-6736(19)32982-4.
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Ruddy, Kathryn J., Hao Guo, Emily L. Baker, Matthew J. Goldstein, Erin E. Mullaney, Lawrence N. Shulman, and Ann H. Partridge. "Randomized phase 2 trial of a coordinated breast cancer follow-up care program." Cancer 122, no. 22 (July 26, 2016): 3546–54. http://dx.doi.org/10.1002/cncr.30206.
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Gitlin, Laura, Kenneth Hepburn, and Sara Czaja. "Transforming Dementia Care: Implementation Challenges Moving Evidence-Based Programs to Health Care." Innovation in Aging 5, Supplement_1 (December 1, 2021): 173. http://dx.doi.org/10.1093/geroni/igab046.661.
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Abstract Although evidence for dementia care programs continues to grow, families and health providers do not have ready access to programs, nor have they been widely disseminated and routinized in healthcare. Understanding implementation considerations when embedding evidence-based programs in healthcare systems can inform ways to effectively transform dementia care. This symposium will examine similarities and differences in implementation challenges encountered and strategies used when implementing four evidence-based programs being tested in different healthcare environments using distinct study designs. Dr. Gaugler et al., will discuss implementation challenges encountered with a staff-delivered intervention (ADS Plus) to support caregivers in adult day services that is being tested using a mixed methods hybrid trial design in >50 sites nationally. Dr. Hodgson et al., will discuss adaptions and their measurement to COPE, a home-based dyadic support program being embedded in 10 PACEs of a large healthcare system using a noninferiority trial testing staff training strategies. Dr. Forester et al., will examine implementation of the Care Ecosystem for dementia patients in a high-risk, integrated care management program using a pilot embedded pragmatic trial. Dr. Hepburn et al., will explore tactical challenges of implementing Tele-Savvy, an online caregiver psychoeducation program, within the context of a pilot pragmatic clinical trial. Drawing upon implementation science, themes discussed include balancing adaptations and fidelity, measurement of implementation outcomes and organizational readiness, and staff training implications. Also highlighted are research design considerations. Dr. Czaja, an expert in the design and implementation of dementia care interventions from in-person to technology-based will be the discussant.
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Gomella, Leonard G., Jianqing Lin, Jean Hoffman-Censits, Patricia Dugan, Fran Guiles, Costas D. Lallas, Jaspreet Singh, et al. "Enhancing Prostate Cancer Care Through the Multidisciplinary Clinic Approach: A 15-Year Experience." Journal of Oncology Practice 6, no. 6 (November 2010): e5-e10. http://dx.doi.org/10.1200/jop.2010.000071.
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The multidisciplinary clinic approach to prostate cancer may enhance outcomes and reduce “treatment regret” through a coordinated presentation of all therapeutic options. This model serves as an interdisciplinary educational tool for patients and their families, and supports clinical trial participation.
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Howe, Kimberly P., John M. Clochesy, Lawrence S. Goldstein, and Hugh Owen. "Mechanical Ventilation Antioxidant Trial." American Journal of Critical Care 24, no. 5 (September 1, 2015): 440–45. http://dx.doi.org/10.4037/ajcc2015335.
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Background Many patients each year require prolonged mechanical ventilation. Inflammatory processes may prevent successful weaning, and evidence indicates that mechanical ventilation induces oxidative stress in the diaphragm, resulting in atrophy and contractile dysfunction of diaphragmatic myofibers. Antioxidant supplementation might mitigate the harmful effects of the oxidative stress induced by mechanical ventilation. Objective To test the clinical effectiveness of antioxidant supplementation in reducing the duration of mechanical ventilation. Methods A randomized, prospective, placebo-controlled double-blind design was used to test whether enterally administered antioxidant supplementation would decrease the duration of mechanical ventilation, all-cause mortality, and length of stay in the intensive care unit and hospital. Patients received vitamin C 1000 mg plus vitamin E 1000 IU, vitamin C 1000 mg plus vitamin E 1000 IU plus N-acetylcysteine 400 mg, or placebo solution as a bolus injection via their enteral feeding tube every 8 hours. Results Clinical and statistically significant differences in duration of mechanical ventilation were seen among the 3 groups (Mantel-Cox log rank statistic = 5.69, df = 1, P = .017). The 3 groups did not differ significantly in all-cause mortality during hospitalization or in the length of stay in the intensive care unit or hospital. Conclusions Enteral administration of antioxidants is a simple, safe, inexpensive, and effective intervention that decreases the duration of mechanical ventilation in critically ill adults.
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Nickels, Marc R., Leanne M. Aitken, James Walsham, Adrian G. Barnett, and Steven M. McPhail. "Critical Care Cycling Study (CYCLIST) trial protocol: a randomised controlled trial of usual care plus additional in-bed cycling sessions versus usual care in the critically ill." BMJ Open 7, no. 10 (October 2017): e017393. http://dx.doi.org/10.1136/bmjopen-2017-017393.
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IntroductionIn-bed cycling with patients with critical illness has been shown to be safe and feasible, and improves physical function outcomes at hospital discharge. The effects of early in-bed cycling on reducing the rate of skeletal muscle atrophy, and associations with physical and cognitive function are unknown.Methods and analysisA single-centre randomised controlled trial in a mixed medical-surgical intensive care unit (ICU) will be conducted. Adult patients (n=68) who are expected to be mechanically ventilated for more than 48 hours and remain in ICU for a further 48 hours from recruitment will be randomly allocated into either (1) a usual care group or (2) a group that receives usual care and additional in-bed cycling sessions. The primary outcome is change in rectus femoris cross-sectional area at day 10 in comparison to baseline measured by blinded assessors. Secondary outcome measures include muscle strength, incidence of ICU-acquired weakness, handgrip strength, time to achieve functional milestones (sitting out of bed, walking), Functional Status Score in ICU, ICU Mobility Scale, 6 min walk test 1 week post-ICU discharge, incidence of delirium and quality of life (EuroQol Five Dimensions questionnaire Five Levels scale). Quality of life assessments will be conducted post-ICU admission at day 10, 3 and 6 months after acute hospital discharge. Participants in the intervention group will complete an acceptability of intervention questionnaire.Ethics and disseminationAppropriate ethical approval from Metro South Health Human Research Ethics Committee has been attained. Results will be published in peer-reviewed publications and presented at scientific conferences to assist planning of future multicentre randomised controlled trials (if indicated) that will test in-bed cycling as an intervention to improve the physical, cognitive and health-related quality of life outcomes of patients with critical illness.Trial registration numberThis trial has been prospectively registered on the Australian and New Zealand Clinical Trial Registry (ACTRN12616000948493); Pre-results.
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Orkin, Julia, Carol Y. Chan, Nora Fayed, Jia Lu Lilian Lin, Nathalie Major, Audrey Lim, Erin R. Peebles, et al. "Complex care for kids Ontario: protocol for a mixed-methods randomised controlled trial of a population-level care coordination initiative for children with medical complexity." BMJ Open 9, no. 8 (August 2019): e028121. http://dx.doi.org/10.1136/bmjopen-2018-028121.
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IntroductionTechnological and medical advances have led to a growing population of children with medical complexity (CMC) defined by substantial medical needs, healthcare utilisation and morbidity. These children are at a high risk of missed, fragmented and/or inappropriate care, and families bear extraordinary financial burden and stress. While small in number (<1% of children), this group uses ~1/3 of all child healthcare resources, and need coordinated care to optimise their health. Complex care for kids Ontario (CCKO) brings researchers, families and healthcare providers together to develop, implement and evaluate a population-level roll-out of care for CMC in Ontario, Canada through a randomised controlled trial (RCT) design. The intervention includes dedicated key workers and the utilisation of coordinated shared care plans.Methods and analysisOur primary objective is to evaluate the CCKO intervention using a randomised waitlist control design. The waitlist approach involves rolling out an intervention over time, whereby all participants are randomised into two groups (A and B) to receive the intervention at different time points determined at random. Baseline measurements are collected at month 0, and groups A and B are compared at months 6 and 12. The primary outcome is the family-prioritized Family Experiences with Coordination of Care (FECC) survey at 12 months. The FECC will be compared between groups using an analysis of covariance with the corresponding baseline score as the covariate. Secondary outcomes include reports of child and parent health outcomes, health system utilisation and process outcomes.Ethics and disseminationResearch ethics approval has been obtained for this multicentre RCT. This trial will assess the effect of a large population-level complex care intervention to determine whether dedicated key workers and coordinated care plans have an impact on improving service delivery and quality of life for CMC and their families.Trial registration numberNCT02928757.
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Vickrey, Barbara. "S2-05-02: A randomized trial of a coordinated care management intervention to improve quality and outcomes of dementia care." Alzheimer's & Dementia 4 (July 2008): T129. http://dx.doi.org/10.1016/j.jalz.2008.05.298.
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de Wolff, Mie G., Julie Midtgaard, Marianne Johansen, Ane L. Rom, Susanne Rosthøj, Ann Tabor, and Hanne K. Hegaard. "Effects of a Midwife-Coordinated Maternity Care Intervention (ChroPreg) vs. Standard Care in Pregnant Women with Chronic Medical Conditions: Results from a Randomized Controlled Trial." International Journal of Environmental Research and Public Health 18, no. 15 (July 25, 2021): 7875. http://dx.doi.org/10.3390/ijerph18157875.
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The proportion of childbearing women with pre-existing chronic medical conditions (CMC) is rising. In a randomized controlled trial, we aimed to evaluate the effects of a midwife-coordinated maternity care intervention (ChroPreg) in pregnant women with CMC. The intervention consisted of three main components: (1) Midwife-coordinated and individualized care, (2) Additional ante-and postpartum consultations, and (3) Specialized known midwives. The primary outcome was the total length of hospital stay (LOS). Secondary outcomes were patient-reported outcomes measuring psychological well-being and satisfaction with maternity care, health utilization, and maternal and infant outcomes. A total of 362 women were randomized to the ChroPreg intervention (n = 131) or Standard Care (n = 131). No differences in LOS were found between groups (median 3.0 days, ChroPreg group 0.1% lower LOS, 95% CI −7.8 to 7%, p = 0.97). Women in the ChroPreg group reported being more satisfied with maternity care measured by the Pregnancy and Childbirth Questionnaire (PCQ) compared with the Standard Care group (mean PCQ 104.5 vs. 98.2, mean difference 6.3, 95% CI 3.0–10.0, p < 0.0001). In conclusion, the ChroPreg intervention did not reduce LOS. However, women in the ChroPreg group were more satisfied with maternity care.
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McLachlan, Sue-Anne, Ann Allenby, Jane Matthews, Andrew Wirth, David Kissane, Michelle Bishop, Jennifer Beresford, and John Zalcberg. "Randomized Trial of Coordinated Psychosocial Interventions Based on Patient Self-Assessments Versus Standard Care to Improve the Psychosocial Functioning of Patients With Cancer." Journal of Clinical Oncology 19, no. 21 (November 1, 2001): 4117–25. http://dx.doi.org/10.1200/jco.2001.19.21.4117.
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PURPOSE: To determine whether making patient-reported cancer needs, quality-of-life (QOL), and psychosocial information available to the health care team, allowing coordinated specifically targeted psychosocial interventions, resulted in reduced cancer needs, improved QOL, and increased satisfaction with care received. METHODS: Self-reported cancer needs, QOL, and psychosocial information was collected from 450 people with cancer, using standardized questionnaires via a touch-screen computer. For a randomly chosen two thirds, this information was made available to the health care team who coordinated targeted psychosocial interventions. Information from the remaining one third was not seen. Patients were assessed 2 and 6 months after randomization for changes in their cancer needs, QOL, and psychosocial functioning and satisfaction with overall care received. RESULTS: There were no significant differences between the two arms with respect to changes in cancer needs, QOL, or psychosocial functioning between the baseline and follow-up assessments, nor with respect to satisfaction with care. However, for the subgroup of patients who were moderately or severely depressed at baseline, there was a significant reduction in depression for the intervention arm relative to the control arm at the 6-month assessment (P = .001). CONCLUSION: Making patient-reported cancer needs, QOL, and psychosocial data available to the health care team at a single consultation together with coordinated psychosocial interventions does not seem to reduce cancer needs nor improve QOL, psychosocial functioning, or satisfaction with the care received. However, identification of patients with moderate or severe levels of depression may be valuable in reducing subsequent levels of depression.
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Thomas, Kim S., Lucy E. Bradshaw, Tracey H. Sach, Jonathan M. Batchelor, Sandra Lawton, Eleanor F. Harrison, Rachel H. Haines, et al. "Silk garments plus standard care compared with standard care for treating eczema in children: A randomised, controlled, observer-blind, pragmatic trial (CLOTHES Trial)." PLOS Medicine 14, no. 4 (April 11, 2017): e1002280. http://dx.doi.org/10.1371/journal.pmed.1002280.
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Harvey, Peter. "Managing health care in Australia: Steps on the health care roundabout?" Australian Journal of Primary Health 9, no. 3 (2003): 105. http://dx.doi.org/10.1071/py03032.
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This paper explores some of the lessons of the coordinated care trials in Australia in the context of managed care in America and asks how do we best manage our finite health care dollars for the most equitable and effective outcomes for whole populations? The COAG trial in Australia tested a more structured process for managing the care of patients with chronic illness and postulated that currently fragmented health system funding could be pooled around individual patient need, and managed for improved economic outcomes and patient wellbeing. There is little doubt, following this initiative and much work in other countries, that as health care costs rise, for a range of reasons, improvements are needed in the management of our resources if we are to control rising health care costs. We also know that chronic illness, much of which is preventable and avoidable, is the major component in the rising health care cost equation and a factor likely to consume around 75% of our health dollars in the future. Much chronic illness can be prevented through social and population health strategies and we know that even if chronic illness can?t be prevented, it can be managed better through community-based chronic illness management programs. These programs rely on information, education, patient lifestyle and behaviour change, and on patients developing improved self-management skills. But, what is the best way to manage population health in Australia and ensure equity and fairness in the health care market as we evolve new approaches, especially to the management of chronic illness?
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Kerure, Amit Shivaji, Satish Udare, and Chetan Vispute. "Role of Lactium™ in Psychodermatology: The CERTAIN Trial# on Patients with Acne Vulgaris." Dermatology Research and Practice 2022 (May 4, 2022): 1–10. http://dx.doi.org/10.1155/2022/2916317.
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Stress plays an important role in the causation and aggravation of psychodermatological conditions such as acne vulgaris. Alpha casein hydrolysate (αs1-casein hydrolysate; Lactium) has been shown to decrease serum cortisol levels, reduce stress-related symptoms, and promote relaxation. “This study aimed to compare the efficacy and safety of Lactium™ plus standard care to those of standard of care alone in reducing stress levels and acne severity in patients with acne vulgaris.” The C.E.R.T.A.I.N trial (Name registered with Clinical Trials Registry-India-No. CTRI/2019/01/017172) is a randomized, controlled, multicenter, open-label, two-arm, investigator-initiated clinical trial. A total of 100 patients with moderate-to-severe acne vulgaris were enrolled and randomly assigned to one of the two groups: Lactium™ plus standard care or standard care alone. Stress levels were assessed using serum cortisol levels, Investigator’s Global Assessment (IGA) acne severity scale scores, Perceived Stress Scale (PSS) scores, and the Hamilton Anxiety Rating Scale (HAM-A) scores. The Dermatology Life Quality Index (DLQI) was also used to assess the impact of the skin disease on patients’ quality of life. At 12 weeks, stress levels were significantly lower in group A (Nixiyax plus standard of care) than that in group B(only standard care), as measured by the change in serum cortisol levels (4.75 ± 4.46 vs. −0.24 ± 5.22). Furthermore, the mean change in PSS scores (3.09 ± 2.04 vs. 0.90 ± 2.76) and HAM-A scores (5.11 ± 1.94 vs. 1.25 ± 3.13) was significant. Patients in both arms had a significant decrease in total, inflammatory, and noninflammatory acne lesions, as well as a significant improvement in DLQI and IGA scores. In patients with moderate-to-severe acne vulgaris, Lactium™ was found to be both safe and well-tolerated. Lactium™ plus standard care is more effective than standard care alone in reducing acne severity through stress reduction.
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Battersby, M., P. McDonald, P. Frith, R. Pearce, C. McGowan, R. Pols, M. Melino, et al. "The sa healthplus coordinated care trial: Developing an outcomes based system of care. Psychiatric outcomes and implications for mental health services." Australian and New Zealand Journal of Psychiatry 34, s1 (January 2000): A5—A6. http://dx.doi.org/10.1080/000486700544.
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Wardley, Andrew M., David Ryder, Vivek Misra, Peter S. Hall, Peter Mackereth, and Jacqui Stringer. "ACUFOCIN: Randomized clinical trial of ACUpuncture plus standard care versus standard care alone FOr Chemotherapy Induced peripheral Neuropathy (CIPN)." Journal of Clinical Oncology 38, no. 15_suppl (May 20, 2020): 12003. http://dx.doi.org/10.1200/jco.2020.38.15_suppl.12003.
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12003 Background: CIPN is a dose limiting toxicity, and a major clinical challenge. This study aims to explore the use of acupuncture with standard care (Acu +SC) against SC alone, to reduce symptoms of CIPN. Methods: A phase II, randomised, parallel group design was used to investigate the effectiveness of a 10 week course of acupuncture to manage CIPN. Patients experiencing CIPN ≥ Grade II (CTCAE v4.03), recording a ‘Most Troublesome’ CIPN symptom score of ≥ 3 using the "Measure Yourself Medical Outcome Profile" (MYMOP 2), were randomised (1:1) to either Acu+SC or SC alone. The primary end-point was a ≥ 2 point improvement in MYMOP2 score at week 10 (logistic regression adjusted for stratification factors and baseline MYMOP2 score). The necessary sample size was 100 patients;120 were randomised to allow for attrition (90% power; 10% one-sided alpha), for a hypothesised improvement in success proportions from 30% to 55%. Results: 120 patients were randomised to ACUFOCIN; diagnosis: breast 61 (51%), multiple myeloma 9 (8%), GI 48 (40%), gynaecological 2 (2%). MYMOP2 score for most troubling CIPN symptom at baseline: 3-4 33 (28%), 5-6 87 (73%). CTCAE CIPN at baseline; grade II 103 (86%), grade III 17 (14%). Baseline characteristics were balanced between arms. Primary outcome data were available for 108 participants with 36/54 (67%) successes in the Acu+SC arm compared to 18/55 (33%) in the SC arm. Adjusted success odds ratio was 4.3 (95% CI 1.9-9.6; p < 0.001; Acu+SC vs SC). Additionally, 27/53 (51%) participants achieved a CIPN success (grade ≤ I) in the Acu+SC arm compared to 4/56 (7%) in the SC arm with adjusted odds ratio 13.1 (95% CI 4.1-41.7; p < 0.001; Acu+SC vs SC). Significant reduction in week 10 pain score; mean difference (SC+Acu – SC alone) -1.45 with 95% CI (-2.25, -0.65) after adjustment for week 1 pain, breast cancer diagnosis and treatment complete status. (note pain on a 0-10 scale). Significant increase in the EORTC QLQ-C30 summary score; mean difference (SC+Acu – SC alone) 9.51 with 95% CI (5.01, 14.02) after adjustment for the baseline score, breast cancer diagnosis and treatment complete status. (note summary score on a 0-100 scale). Significant effects seen at week 10 are also present at week 6. The week 6 effect estimates are consistently less than the week 10 effects (but not usually statistically significantly so). Conclusions: In this patient cohort, a 10 week course of acupuncture significantly improved symptoms of CIPN. These results support further investigation within a phase III trial. Clinical trial information: NCT02275403 .
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Ranson, M. "Randomized Trial of Paclitaxel Plus Supportive Care Versus Supportive Care for Patients With Advanced Non-Small-Cell Lung Cancer." Journal of the National Cancer Institute 92, no. 13 (July 5, 2000): 1074–80. http://dx.doi.org/10.1093/jnci/92.13.1074.
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George, Steven Z., Cynthia J. Coffman, Kelli D. Allen, Trevor A. Lentz, Ashley Choate, Adam P. Goode, Corey B. Simon, et al. "Improving Veteran Access to Integrated Management of Back Pain (AIM-Back): Protocol for an Embedded Pragmatic Cluster-Randomized Trial." Pain Medicine 21, Supplement_2 (December 2020): S62—S72. http://dx.doi.org/10.1093/pm/pnaa348.
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Abstract Background Coordinated efforts between the National Institutes of Health, the Department of Defense, and the Department of Veterans Affairs have built the capacity for large-scale clinical research investigating the effectiveness of nonpharmacologic pain treatments. This is an encouraging development; however, what constitutes best practice for nonpharmacologic management of low back pain (LBP) is largely unknown. Design The Improving Veteran Access to Integrated Management of Back Pain (AIM-Back) trial is an embedded pragmatic cluster-randomized trial that will examine the effectiveness of two different care pathways for LBP. Sixteen primary care clinics will be randomized 1:1 to receive training in delivery of 1) an integrated sequenced-care pathway or 2) a coordinated pain navigator pathway. Primary outcomes are pain interference and physical function (Patient-Reported Outcomes Measurement Information System Short Form [PROMIS-SF]) collected in the electronic health record at 3 months (n=1,680). A subset of veteran participants (n=848) have consented to complete additional surveys at baseline and at 3, 6, and 12 months for supplementary pain and other measures. Summary AIM-Back care pathways will be tested for effectiveness, and treatment heterogeneity will be investigated to identify which veterans may respond best to a given pathway. Health care utilization patterns (including opioid use) will also be compared between care pathways. Therefore, the AIM-Back trial will provide important information that can inform the future delivery of nonpharmacologic treatment of LBP.
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Lewis, Shôn, Nicholas Tarrier, Gillian Haddock, Richard Bentall, Peter Kinderman, David Kingdon, Ronald Siddle, et al. "Randomised controlled trial of cognitive-behavioural therapy in early schizophrenia: Acute-phase outcomes." British Journal of Psychiatry 181, S43 (September 2002): s91—s97. http://dx.doi.org/10.1192/bjp.181.43.s91.
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BackgroundCognitive–behavioural therapy (CBT) improves persistent psychotic symptoms.AimsTo test the effectiveness of added CBT in accelerating remission from acute psychotic symptoms in early schizophrenia.MethodA 5-week CBT programme plus routine care was compared with supportive counselling plus routine care and routine care alone in a multi-centre trial randomising 315 people with DSM–IV schizophrenia and related disorders in their first (83%) or second acute admission. Outcome assessments were blinded.ResultsLinear regression over 70 days showed predicted trends towards faster improvement in the CBT group. Uncorrected univariate comparisons showed significant benefits at 4 but not 6 weeks for CBTv. routine care alone on Positive and Negative Syndrome Scale total and positive sub-scale scores and delusion score and benefits v. supportive counselling for auditory hallucinations score.ConclusionsCBT shows transient advantages over routine care alone or supportive counselling in speeding remission from acute symptoms in early schizophrenia.
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Bourke, Lisa. "Health Consumer Participation in Coordinated Care: A Case Study in the Goulburn Valley." Australian Journal of Primary Health 8, no. 1 (2002): 37. http://dx.doi.org/10.1071/py02006.
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Consumer involvement is at the heart of improving health care, but involving consumers is difficult. This paper documents a process of developing a consumer reference group in northern Victoria to assist in developing a proposal for a coordinated care trial. The Goulburn Valley Consumer Reference Group was developed, maintained and able to meet its objective of developing a model of coordinated care. The group developed good relationships, which fostered commitment, open discussion and debate, and input from all group members. The group identified key issues in rural and regional health care, including access, information, staff shortages, cost, communication and coordination. Although the group is not 'representative', it includes the perspectives of some who do not typically have high rates of participation in health. The success of and problems raised by this process can be used to inform models of consumer participation in health.