Data management and security, safety monitoring, and adverse events. (DOCX 18 kb

Adam Tremblay (4051633)

Ann-Marie Rosland (5556155)

Eve Kerr (554762)

John Piette (4836219)

Michele Heisler (173560)

Ranak Trivedi (5556158)

Shelley Stoll (5556152)

Trials

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.https://deepblue.lib.umich.edu/bitstream/2027.42/145179/1/13063_2018_Article_2785.pd

Rosland, Ann-Marie

Piette, John D

Trivedi, Ranak

Kerr, Eve A

Stoll, Shelley

Tremblay, Adam

Heisler, Michele

Deep Blue Documents at the University of Michigan

English

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

Sample from handbook on teamwork with HCP. (PDF 676 kb

FigShare

Additional file 3: of Engaging family supporters of adult patients with diabetes to improve clinical and patient-centered outcomes: study protocol for a randomized controlled trial

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

Ann-Marie Rosland

John D. Piette

Ranak Trivedi

Eve A. Kerr

Shelley Stoll

Adam Tremblay

Michele Heisler

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