Clinical trial NCT01876485: Point-of-care Health Literacy and Activation Information to Improve Diabetes Care
Official title: Point-of-care Health Literacy and Activation Information to Improve Diabetes Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus
health literacy
patient activation
goals of care
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2013-06-12
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This hybrid effectiveness/implementation trial will be conducted in two phases over four years. In Phase 1, the investigators will evaluate the process of implementing a collaborative, diabetes goal-setting intervention (Empowering Patients in Chronic Care \[EPIC\]) personalized to self-reported patient activation and functional health literacy (FHL) levels into routine primary care practices. In Phase 2, the investigators will conduct a randomized, clinical trial to compare the effectiveness of EPIC to enhanced usual care (EUC). In Phase 2, the investigators will conduct a randomized clinical trial enrolling 284 Veterans with poorly controlled diabetes defined by average hemoglobin A1c over the last six months of \>= 8% to receive EPIC or enhanced usual care (EUC). Consented subjects will be allocated evenly between EPIC and EUC. 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. Patients randomized to EUC will be referred to the PACT RN Care Manager for diabetes management, and will also receive a packet of educational materials regarding diabetes management, including a letter delineating the diabetes management resources available at their facility. Study measurements using self-reported questionnaires and blood tests to assess blood sugar control will be obtained at baseline, post-intervention, and post-six month maintenance period.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in Percent Glycosylated Hemoglobin (HbA1c) Levels During Intervention
timeFrame: HbA1c levels will be measured at baseline, four months, and ten months.
measure: Change in Diabetes Specific Quality of Life
timeFrame: Diabetes specific quality of life will be measured at baseline, four months, and ten months.
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Jesse Brown VA Medical Center, Chicago, IL
state: Illinois
city: Hines
country: United States
facility: Edward Hines Jr. VA Hospital, Hines, IL
state: Illinois
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center, Houston, TX
state: Texas
Study officials:
affiliation: Michael E. DeBakey VA Medical Center, Houston, TX
name: LeChauncy D. Woodard, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arney J, Thurman K, Jones L, Kiefer L, Hundt NE, Naik AD, Woodard LD. Qualitative findings on building a partnered approach to implementation of a group-based diabetes intervention in VA primary care. BMJ Open. 2018 Jan 21;8(1):e018093. doi: 10.1136/bmjopen-2017-018093.
citation: Woodard LD, Adepoju OE, Amspoker AB, Virani SS, Ramsey DJ, Petersen LA, Jones LA, Kiefer L, Mehta P, Naik AD. Impact of Patient-Centered Medical Home Implementation on Diabetes Control in the Veterans Health Administration. J Gen Intern Med. 2018 Aug;33(8):1276-1282. doi: 10.1007/s11606-018-4386-x. Epub 2018 Apr 2.
citation: Woodard L, Amspoker AB, Hundt NE, Gordon HS, Hertz B, Odom E, Utech A, Razjouyan J, Rajan SS, Kamdar N, Lindo J, Kiefer L, Mehta P, Naik AD. Comparison of Collaborative Goal Setting With Enhanced Education for Managing Diabetes-Associated Distress and Hemoglobin A1c Levels: A Randomized Clinical Trial. JAMA Netw Open. 2022 May 2;5(5):e229975. doi: 10.1001/jamanetworkopen.2022.9975.