Engaging family supporters of adult patients with diabetes to improve clinical and patient-centered outcomes: study protocol for a randomized controlled trial

Ann-Marie Rosland, John D Piette, Ranak Trivedi, Eve A Kerr, Shelley Stoll, Adam Tremblay, Michele Heisler, Ann-Marie Rosland, John D Piette, Ranak Trivedi, Eve A Kerr, Shelley Stoll, Adam Tremblay, Michele Heisler

Abstract

Background: Most adults with diabetes who are at high risk for complications have family or friends who are involved in their medical and self-care ("family supporters"). These family supporters are an important resource who could be leveraged to improve patients' engagement in their care and patient health outcomes. However, healthcare teams lack structured and feasible approaches to effectively engage family supporters in patient self-management support. This trial tests a strategy to strengthen the capacity of family supporters to help adults with high-risk diabetes engage in healthcare, successfully enact care plans, and lower risk of diabetes complications.

Methods/design: We will conduct a randomized trial evaluating the CO-IMPACT (Caring Others Increasing EnageMent in Patient Aligned Care Teams) intervention. Two hunded forty adults with diabetes who are at high risk for diabetes complications due to poor glycemic control or high blood pressure will be randomized, along with a family supporter (living either with the patient or remotely), to CO-IMPACT or enhanced usual primary care for 12 months. CO-IMPACT provides patient-supporter dyads: it provides one coaching session addressing supporter techniques for helping patients with behavior change motivation, action planning, and proactive communication with healthcare providers; biweekly automated phone calls to prompt dyad action on new patient health concerns; phone calls to prompt preparation for patients' primary care visits; and primary care visit summaries sent to both patient and supporter. Primary outcomes are changes in patient activation, as measured by the Patient Activation Measure-13, and change in 5-year cardiac event risk, as measured by the United Kingdom Prospective Diabetes Study cardiac risk score for people with diabetes. Secondary outcomes include patients' diabetes self-management behaviors, diabetes distress, and glycemic and blood pressure control. Measures among supporters will include use of effective support techniques, burden, and distress about patient's diabetes care.

Discussion: If effective in improving patient activation and diabetes management, CO-IMPACT will provide healthcare teams with evidence-based tools and techniques to engage patients' available family or friends in supporting patient self-management, even if they live remotely. The core skills addressed by CO-IMPACT can be used by patients and their supporters over time to respond to changing patient health needs and priorities.

Trial registration: ClinicalTrials.gov, NCT02328326 . Registered on 31 December 2014.

Keywords: Action planning; Automated calls; Caregiver; Diabetes mellitus; Health coaching; Interactive voice response; Patient activation; Patient-centered medical home (PCMH); Self-management (SM); Social support.

Conflict of interest statement

Ethics approval and consent to participate

This study was approved by the VA Ann Arbor Human Subjects IRB #2014–247. Trained research assistants will obtain written informed consent and signed Health Insurance Portability and Accountability Act (HIPAA) authorizations for all patients participating in the study. Research assistants will obtain verbal informed consent for all participating Care Partners.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests. AR, JP, RT, EK, AT, and MH are employees of the Veterans Health Administration. The views expressed in this paper are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Theoretical model
Fig. 2
Fig. 2
Schedule of standard protocol items
Fig. 3
Fig. 3
Flow of intervention components

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