A shared-care model of obesity treatment for 3–10 year old children: Protocol for the HopSCOTCH randomised controlled trial

Abstract Background Due to advances in early detection and cancer treatment, 5-year relative survival rates for early breast cancer surpass 90% in developed nations. There is increasing focus on promotion of wellness in survivorship and active approaches to reducing morbidity related to treatment; however, current models of follow-up care are heavily reliant on hospital-based specialist-led care. This study aims to test the feasibility of the EMINENT intervention for implementing an integrated, shared-care model involving both cancer centre specialists and community-based general practitioners for early breast cancer post-treatment follow-up. Methods We describe a protocol for a phase II, randomised controlled trial with two parallel arms and 1:1 allocation. A total of 60 patients with early-stage breast cancer will be randomised to usual, specialist-led, follow-up care (as determined by the treating surgeons, medical oncologists, and radiation oncologists) or shared follow-up care intervention (i.e. EMINENT). EMINENT is a nurse-enabled, pre-specified shared-care pathway with follow-up responsibilities divided between cancer centre specialists (i.e. surgeons and oncologists) and general practitioners. The primary outcome is health-related quality of life as measured by the Functional Assessment of Cancer Therapy—Breast Cancer. Secondary outcomes include patient experience, acceptance, and satisfaction of care; dietary, physical activity, and sedentary behaviours; financial toxicity; adherence; health resource utilisation; and adverse events. Discussion The trial is designed to identify the barriers to implementing a shared-care model for breast cancer survivors following treatment. Results of this study will inform a definitive trial testing the effects of shared-care model on health-related quality of life of breast cancer survivors, as well as its ability to alleviate the growing demands on the healthcare system. Trial registration Australia and New Zealand Clinical Trials Registry ACTRN12619001594112. Registered on 19 November 2019

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Faculty Opinions recommendation of Effects of a transitional palliative care model on patients with end-stage heart failure: a randomised controlled trial.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.726213930.793517382 ◽

2016 ◽

Author(s):

Janet Abrahm

Keyword(s):

Heart Failure ◽

Palliative Care ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Care Model ◽

End Stage Heart Failure ◽

Randomised Controlled ◽

End Stage

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Effectiveness and cost-effectiveness of a people-centred care model for community-living older people versus usual care ─ A randomised controlled trial

Research in Social and Administrative Pharmacy ◽

10.1016/j.sapharm.2021.07.025 ◽

2021 ◽

Author(s):

Heini Kari ◽

Nelli Äijö-Jensen ◽

Hanna Kortejärvi ◽

Jukka Ronkainen ◽

Marjo Yliperttula ◽

...

Keyword(s):

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Older People ◽

Usual Care ◽

Controlled Trial ◽

Community Living ◽

Care Model ◽

Randomised Controlled

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Swāsthya, an integrated chronic condition management programme for families of patients with hypertension and diabetes mellitus: a study protocol for a randomised controlled trial

BMC Family Practice ◽

10.1186/s12875-020-01357-w ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

M D Saju ◽

Bindiya M Varghese ◽

Lorane Scaria ◽

Anuja Maria Benny ◽

Shilpa V Yohannan ◽

...

Keyword(s):

Diabetes Mellitus ◽

Risk Factors ◽

Randomised Controlled Trial ◽

Social Cohesion ◽

Chronic Conditions ◽

Chronic Condition ◽

Controlled Trial ◽

Risk Groups ◽

Care Model ◽

Randomised Controlled

Abstract Background Kerala is known as the diabetes mellitus (DM) and hypertension (HTN) capital of the world, thus compelling health professionals to model strategies, addressing their social, behavioural, and cognitive risk factors and eliminating various barriers to management. This paper describes the protocol of our study that aims to examine the effectiveness and sustainability of an integrated care model for the management of chronic conditions and their risk factors through a family-based intervention. The proposed care model targets to modify systems and processes that predispose to chronic conditions by enhancing social cohesion and social networks, preventing lifestyle risks, developing iterative cognitive interventions, and engaging the family into customised treatment adherence strategies navigated by community health social workers (CHSWs). Methods A cluster randomised controlled trial (RCT) in selected participants will be conducted involving additional assessments prior to the baseline assessment. The assessment will identify and categorise patients into four risk groups, namely behavioural, social, cognitive, and multiple, based on dominant risks identified. Eligible participants will be randomly allocated (at a ratio of 1:1) into the intervention or control arm. The intervention arm will receive social, behavioural, and cognitive or multiple interventions corresponding to the identified risk groups, whereas the control arm will receive general intervention. Both the groups will be followed up at 6 months and 12 months post baseline to measure outcomes. The primary outcome will be the control of HTN and DM, and secondary outcomes include decreased depression and anxiety and improved functioning, social cohesion, and social network linkages. The sustainability and scalability of this intervention will be assessed through cost effectiveness, acceptability, and user friendliness of the integrated approach by performing a qualitative evaluation. Discussion This RCT will inform the potential paradigm shift from a medical model of chronic condition management to a multidimensional, multisystem, and multidisciplinary convergence model navigated by CHSWs. Such a model is not currently considered in the management of chronic conditions in Kerala. Trial registration Trial has been prospectively registered on Clinical Trial Registry of India- CTRI/2020/12/029474 on 1st December 2020.

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