Caring Others Increasing EngageMent in PACT (CO-IMPACT)

Engaging Veterans and Family Supporters in PACT to Improve Diabetes Management

This trial will compare two methods of increasing engagement in care and success in diabetes management, among patients with diabetes with high-risk features, who also have family members involved in their care.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Other: CO-IMPACT; Other: PACT

Detailed Description

Background:

Veterans with diabetes must control cardiovascular risk factors in order to prevent disabling and life-threatening complications. However, despite system wide advances in diabetes quality of care, over 30% of VHA patients with diabetes continue to have uncontrolled blood pressure, hyperglycemia, or hyperlipidemia. The nationwide VA PACT (Patient-Aligned Care Teams) initiative seeks to provide patients comprehensive, team-based support for following diabetes care regimens. PACT's success, however, hinges on its ability to effectively engage patients in care. One relatively untapped resource for supporting engagement in PACT is patients' family and friends. Three out of four adults with diabetes reach out to an unpaid family member or friend (a 'Care Partner') for ongoing help with diabetes management. These supporters help patients with medication adherence, tracking home glucose measurements, maintaining a healthy eating plan, and often accompany patients to their medical visits. However, while PACT emphasizes the importance of family members as part of the care team, PACT does not have formal mechanisms to involve health supporters in PACT care. Health supporters report that, in order to be more effective, they need more information on patient's medical care plans, clear channels for communicating with PACT team members, and information on navigating PACT resources.

Objectives:

The overall objective of this randomized trial is to test a strategy to strengthen the capacity of supporters to help patients with high-risk diabetes engage in PACT care and successfully enact care plans.

The central hypothesis is that providing health care engagement tools to both Care Partners and patients will increase patient activation and improve management of diabetes complication risks.

Methods:

This is a randomized controlled trial evaluating an intervention (Caring Others Increasing EngageMent in PACT, or CO-IMPACT) designed to structure and facilitate health supporter involvement in PACT so that patients can become more actively engaged in PACT care. 240 patients with diabetes receiving PACT primary care who: 1) are at high risk for diabetes complications due to hyperglycemia OR high blood pressure and 2) have a health supporter involved in their care will be recruited along with their health supporter. Patient-supporter dyads are randomized to the CO-IMPACT intervention or usual PACT care for high-risk diabetes, for 12 months.

The intervention provides patient-supporter dyads: one coaching session on action planning, communicating with providers, navigation skills and support skills; preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns. CO-IMPACT builds on medical record-integrated patient activation tools in the PACT toolkit and is designed to be implementable within existing PACT nurse encounters.

Primary outcomes for this study include a validated measure of patient activation (Patient Activation Measure-13) and a cardiac event 5-year risk score designed for patients with diabetes (UKPDS Risk Engine). Secondary outcomes include patients' self-efficacy for diabetes self-care; diabetes self-management behaviors including medication adherence; diabetes distress; and glycemic and blood pressure control. Measures among supporters include supporter activation, use of effective support techniques, distress about patient's diabetes care, and caregiver burden. We are also measuring patient-supporter and patient-provider relationship quality, patient safety (e.g. hypoglycemia), utilization, potential moderators of intervention effect such as patient health literacy level, and facilitators and barriers to wider implementation.

• Study Type: Interventional
• Enrollment (Actual): 478
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • VA Ann Arbor Healthcare System, Ann Arbor, MI
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15240
      • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Patient Inclusion Criteria:

• Provide signed and dated informed consent form
• Plan to be be available for the duration of the study
• Male or female, age 30-70 years old
• Plan to get most diabetes care at recruiting VA primary care clinic over the subsequent 12 months
• Able to use telephone to respond to bi-weekly automated Interactive Voice Response (IVR) calls
• Be able to identify an adult family member or friend who is regularly involved in their health management or health care (involved with medications, managing sugars, coming to appointments, etc)
• Have a diagnosis of diabetes and be at high-risk for diabetes complications, defined as: (1) a diagnosis of diabetes based on encounter diagnoses from 1 inpatient or 2 outpatient encounters (OR a diabetes medication (at least one >3 month prescription from VA drug classes HS501 (insulin) or HS502, other than metformin), (2) have an assigned VAprimary care provider and at least 2 visits to VA primary care in the previous 12 months, (3) poor glycemic control (last HbA1C within 9 months >8%) OR poor blood pressure control (last BP 160/100 or mean 6 month BP >150/90)

Care Partner Inclusion Criteria:

• 21 years old or older
• Fluent in English
• Live in the United States

Exclusion Criteria:

Patient Exclusion Criteria:

• Expect to have >1 month gap in VA care in the 12 months following enrollment (e.g. snowbird travel).
• Plan to receive the majority of their care for diabetes mainly from a non-Primary Care provider in the 12 months following enrollment
• Have a VA resident/trainee as their main primary care provider
• Live in a nursing home OR assisted living
• Have significant cognitive impairment as measured by an Electronic Medical Record (EMR) diagnosis of Alzheimer's disease or dementia, or a score of <4 on the Callahan screener to identify cognitive impairment
• Need help with more than two basic activities of daily living (ADLs) as measured by the Katz Basic Activities of Daily Living Scale
• Do not speak English
• Have a life-limiting severe illness (such as stage renal disease [ESRD] requiring dialysis, chronic obstructive pulmonary disease (COPD) requiring oxygen, cancer undergoing active treatment, receiving palliative/hospice care)
• Are concurrently enrolled in another research study or clinical program, at time of enrollment, that could conflict with the current study's protocol (e.g. another diabetes management research intervention, or VA tele-buddy program involving frequent phone calls)
• Do not have a working phone or are not able to use a telephone to respond to automated IVR calls
• Currently Pregnant or planning to become pregnant at time of enrollment
• Have a serious mental illness or active substance abuse issue

Care Partner Exclusion Criteria:

• Receive pay for caring for the patient
• talks with patient about health less than two times per month
• Have significant cognitive impairment as measured by a score of 4 or less <4 on the Callahan screener to identify cognitive impairment
• Need help with more than two basic ADL as measured by the Katz Basic Activities of Daily Living Scale
• Have a life-limiting severe illness (such as end-stage renal disease requiring dialysis, chronic lung disease requiring oxygen, cancer undergoing active treatment, receiving palliative/hospice care)
• Ever told by a doctor they have dementia, schizophrenia, or manic depression

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CO-IMPACT; patient and supporter (dyad) receive one coaching session on action planning, communicating with providers, navigation skills and support skills; preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns	Other: CO-IMPACT; Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter
Active Comparator: PACT; patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which includes (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits	Other: PACT; participants will receive PACT care for high-risk diabetes, which includes (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Patient Activation, as Measured by Patient Activation Measure - 13	Patient Activation Measure-13. Range of potential values (0,100), higher scores mean a better outcome, Outcome is the participant's difference in the measure between baseline and 12 months, among patient participants	Baseline to 12 months
Change in Cardiac Event 5-year Risk Score, as Measured by UKPDS Risk Engine	UKPDS Risk Engine, among patient participants only, range is 0 to 100% risk of cardiac event over the next 5 years. Lower score equals a better outcome. Outcome is the participant's difference in the measure between baseline and 12 months.	Baseline to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Diabetes Self-Management Behavior - Healthy Eating	Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values for healthy eating subscale (0 - 7 days per week), higher scores mean better outcomes, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.	Baseline to 12 months
Change in Glycemic Control	Hemoglobin A1c, among patient participants. Common range is 4% to 14%, lower values indicate better outcomes. Outcome is the participant's difference in the measure between baseline and 12 months.	Baseline to 12 months
Change in Systolic Blood Pressure	mmHg, Average of two readings done at each time point. Common physiologic range is 80mmHg - 220mmHg. Lower values indicate better outcomes, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.	Baseline to 12 months
Change in Diabetes Distress	Problem Areas in Diabetes Scale (PAID) - range of potential values (0,20), higher scores indicate worse outcomes (greater diabetes-related emotional distress), among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.	Baseline to 12 months
Change in Activation in Health Encounters	Perceived Efficacy in Patient-Physician Interactions (PEPPI-5) - range of potential values (5, 25), higher scores indicate better outcomes (higher perceived self-efficacy in patient-physician interactions), among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.	Baseline to 12 months
Change in Non-Fasting Lipid Levels	Total cholesterol mg/DL to HDL mg/DL Ratio, common range is 1-10, lower values indicate better outcomes, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.	Baseline to 12 months
Change in Patient Satisfaction With Healthcare System Support for Family Supporter	Measured as percent of patient participants answering they were 'very satisfied' or 'satisfied' with healthcare system support for their Care Partner (family supporter)'s participation in their healthcare. Response options were 'very unsatisfied', 'unsatisfied', 'neither', 'satisfied', or 'very satisfied'. Increase in proportion of 'very satisfied' or 'satisfied' indicates better outcomes (higher satisfaction), among patient participants.	Baseline to 12 months
Change in Supporter Use of Autonomy-Supportive Communication	Important Other Climate Questionnaire (IOCQ) - patient rating of supporter communication. Range of potential values (1,7), higher scores indicate better outcomes (higher patient perception of supporter use of autonomy supportive communication), among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.	Baseline to 12 months
Change in Smoking Status	Global Adult Tobacco Survey, values include 'current smoker', 'former smoker', or 'never smoker'. Change from current to former smoker over 12 months indicates a better outcome. Measured among patient participants.	Baseline to 12 months
Change in Diabetes Self-Management Behavior - Physical Activity	Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values for physical activity subscale (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.	Baseline to 12 months
Change in Diabetes Self-Management Behavior - Blood Sugar Home Testing	Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.	Baseline to 12 months
Change in Diabetes Self-Management Behavior - Blood Pressure Home Testing	Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.	Baseline to 12 months
Change in Diabetes Self-Management Behavior - Take Oral Meds as Prescribed	Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.	Baseline to 12 months
Change in Diabetes Self-Management Behavior - Take Insulin as Prescribed	Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.	Baseline to 12 months
Change in Diabetes Self-Management Behavior - Check Feet	Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.	Baseline to 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Diabetes Self-Efficacy	Adapted Stanford Chronic Disease self-efficacy scale, among patient participants. Range of potential values (1,10), higher score indicates higher self-efficacy. Outcome is the participant's difference in the measure between baseline and 12 months.	Baseline to 12 months
Change in Supporter Self-Efficacy for Helping With Diabetes Care	Adapted Stanford Chronic Disease self-efficacy scale, among family supporter participants. Range of potential values (1,10), higher score indicates higher self-efficacy. Outcome is the participant's difference in the measure between baseline and 12 months.	Baseline to 12 months
Change in Caregiver Burden	Caregiver Strain Index - range of potential values (0,13), higher scores (7 or more) mean worse outcomes, among family supporter participants. Outcome is the participant's difference in the measure between baseline and 12 months.	Baseline to 12 months
Change in Supporter Distress About Patient Participant's Diabetes	Adapted Problem Areas In Diabetes Scale (PAID) - range of potential values (0,20), higher scores indicate worse outcomes (greater diabetes-related emotional distress), among family supporter participants. Outcome is the participant's difference in the measure between baseline and 12 months.	Baseline to 12 months

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Ann-Marie Rosland, MD MS, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Publications and helpful links

General Publications

• Rosland AM, Piette JD, Trivedi R, Kerr EA, Stoll S, Tremblay A, Heisler M. Engaging family supporters of adult patients with diabetes to improve clinical and patient-centered outcomes: study protocol for a randomized controlled trial. Trials. 2018 Jul 24;19(1):394. doi: 10.1186/s13063-018-2785-2.
• Zupa MF, Lee A, Piette JD, Trivedi R, Youk A, Heisler M, Rosland AM. Impact of a Dyadic Intervention on Family Supporter Involvement in Helping Adults Manage Type 2 Diabetes. J Gen Intern Med. 2022 Mar;37(4):761-768. doi: 10.1007/s11606-021-06946-8. Epub 2021 Jul 8.
• Rosland AM, Piette JD, Trivedi R, Lee A, Stoll S, Youk AO, Obrosky DS, Deverts D, Kerr EA, Heisler M. Effectiveness of a Health Coaching Intervention for Patient-Family Dyads to Improve Outcomes Among Adults With Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2022 Nov 1;5(11):e2237960. doi: 10.1001/jamanetworkopen.2022.37960.

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2016
• Primary Completion (Actual): June 6, 2019
• Study Completion (Actual): June 6, 2020

Study Registration Dates

• First Submitted: December 10, 2014
• First Submitted That Met QC Criteria: December 29, 2014
• First Posted (Estimate): December 31, 2014

Study Record Updates

• Last Update Posted (Actual): October 6, 2021
• Last Update Submitted That Met QC Criteria: September 9, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Diabetes; patient activation; social support; diabetes self-management
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: IIR 14-074

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Final dataset underlying publication resulting from this research will be shared upon request. Members of the scientific community can request a de-identified copy of the final dataset (i.e., dataset underlying any publication).
• IPD Sharing Access Criteria: Members of the scientific community should contact the PI. De-identified data may only be provided after requestors and data providers sign a standard federal agency Data Use Agreement.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No