Caring Others Increasing EngageMent in PACT

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.

Status:

Recruitment was scheduled to begin in early 2016 but was delayed while the study team secured
a cloud-based server that meets VA security requirements. Recruitment began in November 2016,
and we are meeting our monthly recruitment goals.

As of early May 2018, 233 dyads have been enrolled, so we are well on our way to our goal of
recruiting a total of 240 dyads by June 2018. Approximately half have been randomized to the
intervention and half to usual care. All will receive 12 month follow-up. 141 of the expected
151 patients have completed 6 month data assessments, with a completion rate of 93%. 24 of
the expected 25 patients have completed 12 month data assessments, with a completion rate of
96%. 137 of the expected 148 Care Partners have completed 6 month data assessments, with a
completion rate of 93%. 22 of the expected 25 Care Partners have completed 12 month data
assessments, with a completion rate of 88%. The power calculation allowed for a retention
rate as low as 80%.

98% (115/117) of patients in the intervention arm have completed their initial coaching
session, and 97% (113/117) of Care Partners have completed the same initial coaching session.
Following the initial coaching session, intervention patients receive an automated call every
two weeks for one year. 75% of the scheduled automated calls are completed. A total of four
patients have withdrawn or been withdrawn from the study, and none of the withdrawals were
related to dissatisfaction with the study.

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