Clinical trial NCT02328326: Caring Others Increasing EngageMent in PACT
Official title: Engaging Veterans and Family Supporters in PACT to Improve Diabetes Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Diabetes
diabetes self-management
patient activation
social support
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2014-12-31
Enrollment: 478
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Patient Activation, as Measured by Patient Activation Measure - 13
timeFrame: Baseline to 12 months
measure: Change in Cardiac Event 5-year Risk Score, as Measured by UKPDS Risk Engine
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Change in Diabetes Self-Management Behavior - Healthy Eating
timeFrame: Baseline to 12 months
measure: Change in Glycemic Control
timeFrame: Baseline to 12 months
measure: Change in Systolic Blood Pressure
timeFrame: Baseline to 12 months
measure: Change in Diabetes Distress
timeFrame: Baseline to 12 months
measure: Change in Activation in Health Encounters
timeFrame: Baseline to 12 months
measure: Change in Non-Fasting Lipid Levels
timeFrame: Baseline to 12 months
measure: Change in Patient Satisfaction With Healthcare System Support for Family Supporter
timeFrame: Baseline to 12 months
measure: Change in Supporter Use of Autonomy-Supportive Communication
timeFrame: Baseline to 12 months
measure: Change in Smoking Status
timeFrame: Baseline to 12 months
measure: Change in Diabetes Self-Management Behavior - Physical Activity
timeFrame: Baseline to 12 months
measure: Change in Diabetes Self-Management Behavior - Blood Sugar Home Testing
timeFrame: Baseline to 12 months
measure: Change in Diabetes Self-Management Behavior - Blood Pressure Home Testing
timeFrame: Baseline to 12 months
measure: Change in Diabetes Self-Management Behavior - Take Oral Meds as Prescribed
timeFrame: Baseline to 12 months
measure: Change in Diabetes Self-Management Behavior - Take Insulin as Prescribed
timeFrame: Baseline to 12 months
measure: Change in Diabetes Self-Management Behavior - Check Feet
timeFrame: Baseline to 12 months
Other outcomes:
measure: Change in Diabetes Self-Efficacy
timeFrame: Baseline to 12 months
measure: Change in Supporter Self-Efficacy for Helping With Diabetes Care
timeFrame: Baseline to 12 months
measure: Change in Caregiver Burden
timeFrame: Baseline to 12 months
measure: Change in Supporter Distress About Patient Participant's Diabetes
timeFrame: Baseline to 12 months
Locations:
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System, Ann Arbor, MI
state: Michigan
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
state: Pennsylvania
Study officials:
affiliation: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
name: Ann-Marie Rosland, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.