Point-of-care Health Literacy and Activation Information to Improve Diabetes Care

Project Background: Diabetes mellitus is a highly prevalent chronic condition, affecting one
in four Veterans who use the Veterans Affairs (VA) health care system. Self-management skills
are critical for controlling diabetes and reducing its cardiovascular sequela. Providing
diabetic patients with effective self-management training and support can be challenging due
to time constraints at primary care encounters and limited clinician training with behavior
change. The investigators have previously demonstrated that a group-based, VA primary care
intervention to help patients set highly effective, evidence-based diabetes goals had a
positive impact on both diabetes self-efficacy and hemoglobin (Hb) A1c levels. This study
aims to evaluate the process of implementing a collaborative goal-setting intervention
personalized to patient activation and health literacy levels (i.e. Empowering Patients in
Chronic Care [EPIC]) into routine PACT care and to evaluate the effectiveness of this
intervention relative to usual care.

Project Objectives: Specific Aim 1: Assess effective processes for and costs associated with
implementing a collaborative diabetes goal-setting intervention personalized to patient
activation and FHL (i.e., EPIC) into the routine workflows of PACTs. H1: Formative measures
within the PARIHS framework (evidence, context, facilitation) will be associated with
implementation of EPIC (defined by reach, adoption, cost effectiveness, and fidelity
measures) into routine PACT care. Specific Aim 2: Evaluate the effectiveness of delivering
collaborative goal-setting personalized to patient activation and FHL on clinical (HbA1c) and
patient-centered (Diabetes Distress Scale) outcomes among eligible patients in enrolled
PACTs. H2: Patients receiving collaborative goal-setting personalized to activation and FHL
levels will have significant improvements in a) HbA1c and b) Diabetes Distress Scale levels,
respectively, at post-intervention compared with patients receiving enhanced usual care. H3:
Patients receiving collaborative goal-setting personalized to activation and FHL levels will
maintain significant improvements in a) HbA1c and b) Diabetes Distress Scale levels at
post-maintenance follow-up, respectively, compared with patients receiving enhanced usual
care.

Project Methods: In Phase 1 of the study, the investigators will implement EPIC into routine
PACT care. The investigators will conduct a mixed-methods formative evaluation that includes
33-48 key informant interviews with VA leadership, clinicians, and staff and an assessment of
organizational readiness for change. This evaluation will identify how group and one-on-one
sessions of EPIC can best be implemented into routine workflows of PACT. In Phase 2, the
investigators will conduct a randomized clinical trial enrolling 284 patients with poorly
controlled diabetes defined by average hemoglobin A1c of 8% to receive EPIC or enhanced usual
care. The patient will serve as the unit of randomization. EPIC consists of six 1-hour group
sessions focusing on 1) Your Health, Your Values, 2) Diabetes ABCs, 3) Setting Goals and
Making Action Plans, 4) Communication with Your Health Care Provider, 5) Staying Committed to
Your Goals, and 6) Reviewing and Planning for the Future. After each group session, a
one-on-one session between a designated PACT member and patient participants will focus on
collaborative goal-setting. Designated PACT members will be trained to personalize
goal-setting using patient-reported activation and health literacy data. The investigators
will collect laboratory and survey data at baseline, post-intervention, and post-maintenance
phase. The investigators will evaluate the effectiveness of personalized goal-setting
compared to enhanced usual care on clinical (e.g., hemoglobin A1c) and patient-centered
(e.g., Diabetes Distress Scale) outcomes.

Inclusion Criteria:

- Veterans receiving primary care at VA study sites who are enrolled in the panels of
participating primary care teams

- Veterans with ICD-9-CM and/or ICD-10 codes indicating a diagnosis of diabetes

- Veterans with an average HbA1c level > 8% in the prior 6 months

Exclusion Criteria:

The investigators will exclude Veterans with the following clinical conditions that would
render participation in a group clinic inappropriate:

- metastatic cancer or receiving hospice care

- limited life expectancy

- clinician recommendations to not titrate therapy due to prior history of significant
hypoglycemic events

- age <18 years

- active bipolar or psychotic disorder

The investigators will also exclude Veterans, who at the time of screening:

- cannot attend monthly group clinic sessions due to transportation or availability
barriers

- have significant cognitive impairment

- have active substance-abuse disorders

- are not comfortable discussing their health and health care in a peer-group setting
Patients will be secondarily excluded if their HbA1C level falls below 7.5% at
baseline.