The Aging, Community and Health Research Unit Community Partnership Program (ACHRU-CPP) for\xa0older adults with diabetes and multiple chronic conditions: study protocol for a randomized\xa0controlled trial

Jenny Ploeg ,Gary F Lewis ,Johanne Blais ,France Légaré ,Janet M Pritchard ,Ross Upshur ,Kathryn Fisher ,Robyn Connors ,William Montelpare ,Janet Macintyre ,Ruta Valaitis ,Marie‐Lee Yous ,Maureen Markle‐Reid ,Cheryl A Sadowski ,Melissa Northwood ,Ali Ben Charif ,Amiram Gafni ,Lynne Mansell ,Tyler K Williamson ,Rebecca Ganann ,Jean‐Sébastien Paquette ,Angela Riveroll ,Andrea Gruneir ,Diana Sherifali ,Marie-Ève Poitras ,Tracey Chambers ,Lehana Thabane ,Dean T Eurich ,Frank Tang

doi:10.1186/s12877-021-02651-7

Abstract

BackgroundOlder adults (≥65 years) with diabetes and multiple chronic conditions (MCC) (> 2 chronic conditions) experience reduced function and quality of life, increased health service use, and high mortality. Many community-based self-management interventions have been developed for this group, however the evidence for their effectiveness is limited. This paper presents the protocol for a randomized controlled trial (RCT) comparing the effectiveness and implementation of the Aging, Community and Health Research Unit-Community Partnership Program (ACHRU-CPP) to usual care in older adults with diabetes and MCC and their caregivers.MethodsWe will conduct a cross-jurisdictional, multi-site implementation-effectiveness type II hybrid RCT. Eligibility criteria are: ≥65 years, diabetes diagnosis (Type 1 or 2) and at least one other chronic condition, and enrolled in a primary care or diabetes education program. Participants will be randomly assigned to the intervention (ACHRU-CPP) or control arm (1:1 ratio). The intervention arm consists of home/telephone visits, monthly group wellness sessions, multidisciplinary case conferences, and system navigation support. It will be delivered by registered nurses and registered dietitians/nutritionists from participating primary care or diabetes education programs and program coordinators from community-based organizations. The control arm consists of usual care provided by the primary care setting or diabetes education program. The primary outcome is the change from baseline to 6 months in mental functioning. Secondary outcomes will include, for example, the change from baseline to 6 months in physical functioning, diabetes self-management, depressive symptoms, and cost of use of healthcare services. Analysis of covariance (ANCOVA) models will be used to analyze all outcomes, with intention-to-treat analysis using multiple imputation to address missing data. Descriptive and qualitative data from older adults, caregivers and intervention teams will be used to examine intervention implementation, site-specific adaptations, and scalability potential.DiscussionAn interprofessional intervention supporting self-management may be effective in improving health outcomes and client/caregiver experience and reducing service use and costs in this complex population. This pragmatic trial includes a scalability assessment which considers a range of effectiveness and implementation criteria to inform the future scale-up of the ACHRU-CPP.Trial registrationClinical Trials.gov Identifier NCT03664583. Registration date: September 10, 2018.

Highlights

Older adults (≥65 years) with diabetes and multiple chronic conditions (MCC) (> 2 chronic conditions) experience reduced function and quality of life, increased health service use, and high mortality
This study focuses on evaluating and scaling up the Aging, Community and Health Research Unit Community Partnership Program (ACHRU-CPP), an intervention that was co-designed by clients, caregivers, primary care providers and researchers [30]
Some of the methodological components for this trial were published in the study protocol for the previous randomized controlled trial (RCT) testing the same intervention, we briefly summarize these methods in this paper and refer to the prior protocol paper for the details [46]

Summary

Introduction

Older adults (≥65 years) with diabetes and multiple chronic conditions (MCC) (> 2 chronic conditions) experience reduced function and quality of life, increased health service use, and high mortality. Persons with diabetes who have higher comorbidity burden face additional care challenges that result in higher levels of functional impairment, reduced quality of life, increased health service use, and higher mortality [2, 4]. Caregivers experience negative impacts of caregiving including poorer mental and physical health and financial costs [7]. Caregivers report that their needs are not addressed [8], potentially resulting in increased use of acute care services (e.g., hospitalization, emergency department (ED) visits) [9]

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