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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01876485
First received: June 10, 2013
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

This hybrid effectiveness/implementation trial will be conducted in two phases over four years. In Phase 1, we 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, we will conduct a randomized, clinical trial to compare the effectiveness of EPIC to enhanced usual care (EUC). In the proposed clinical trial, we will enroll 32 primary care teams (referred to as Patient Aligned Care Teams [PACT] in the VA) and recruit an average of 12 patients per team with treated but uncontrolled diabetes. Patients in the intervention arm will receive EPIC group training sessions consisting of 4 one-hour group sessions led by clinical research staff occurring over a 6-month period. Group sessions will consist of behavioral coaching focused on diabetes management. Following each group-session, patients enrolled in the intervention arm will meet with a designated member of the primary care team to personalize diabetes goals and action plans. Patients in the control arm will receive EUC consisting of a diabetes group education class, an appointment with the nutritionist, an appointment with the clinical pharmacist for medication management, and a primary care visit dedicated to diabetes management. Providers of patients in the EUC arm will receive standardized recommendations for diabetes self management education. Study measurements using self-reported questionnaires and blood tests to assess blood sugar control will be obtained at baseline, six months and one year.


Condition Intervention Phase
Diabetes Mellitus
Behavioral: Empowering Patients in Chronic Care (EPIC)
Behavioral: Enhanced Usual Care (EUC)
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Point-of-care Health Literacy and Activation Information to Improve Diabetes Care

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Changes in Hemoglobin A1c levels during intervention [ Time Frame: Hemoglobin A1c levels will be measured at baseline, six months, and one year. ] [ Designated as safety issue: No ]
    Measures of Hemoglobin A1c will be taken to assess average blood glucose levels throughout the study as an indicator of diabetes control.


Secondary Outcome Measures:
  • Change in diabetes specific quality of life [ Time Frame: Diabetes specific quality of life will be measured at baseline, six months, and one year. ] [ Designated as safety issue: No ]
    The Diabetes Distress Scale will be used to assess diabetes quality of life throughout the study.

  • Changes in self-efficacy [ Time Frame: Self-efficacy will be assessed at baseline, six months, and one year. ] [ Designated as safety issue: No ]
    This measure is a part of our broader mediators and moderators analysis within our proposed conceptual model.

  • Change in medication adherence [ Time Frame: Medication adherence will be assessed at baseline, six months, and one year. ] [ Designated as safety issue: No ]
    This measure is a part of our broader mediators and moderators analysis within our proposed conceptual model.

  • Change in self management behavior [ Time Frame: Self management behavior will be assessed at baseline, six months, and twelve months. ] [ Designated as safety issue: No ]
    This measure is a part of our broader mediators and moderators analysis within our proposed conceptual model.


Estimated Enrollment: 260
Study Start Date: January 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Patients in the intervention arm will receive the Empowering Patients in Chronic Care group training sessions consisting of 4 one-hour group sessions occurring over a 6-month period. Group sessions will consist of behavioral coaching focused on diabetes management. Following each group-session, patients enrolled in the intervention arm will meet with a designated member of their primary care team to personalize diabetes goals and action plans.
Behavioral: Empowering Patients in Chronic Care (EPIC)
EPIC group training sessions consisting of 4 one-hour group sessions occurring over a 6-month period. Group sessions will consist of behavioral coaching focused on diabetes management. Following each group-session, patients enrolled in the intervention arm will meet with a designated member of their primary care team to personalize diabetes goals and action plans.
Active Comparator: Arm 2
The Enhanced Usual Care (EUC) arm will serve as a concurrent control group to compare to the intervention arm of the study. EUC will consist of a diabetes group education class, appointment with the nutritionist an appointment with the clinical pharmacist for medication management, and a primary care visit dedicated to diabetes management. Providers of patients in the EUC arm will receive standardized recommendations for diabetes self management education.
Behavioral: Enhanced Usual Care (EUC)
EUC will consist of a diabetes group education class, appointment with the nutritionist, an appointment with the clinical pharmacist for medication management, and a primary care visit dedicated to diabetes management. Providers of patients in the EUC arm will receive standardized recommendations for diabetes self management education.

Detailed Description:

Project Background: Diabetes mellitus is a highly prevalent chronic condition, affecting one in five 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. We 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 VISN 12 PACT care and to evaluate the effectiveness 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 VISN 12 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 6-months (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 1-year follow-up, respectively, compared with patients receiving enhanced usual care.

Project Methods: In Phase 1 of the study, we will implement EPIC into routine PACT care. We will conduct a mixed-methods formative evaluation that includes 33-48 key informant interviews with VISN 12 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 VISN 12 PACT. In Phase 2, we will conduct a randomized clinical trial enrolling 32 designated PACT members and 260 of their patients with poorly controlled diabetes defined by average hemoglobin A1c of 8% to receive EPIC or enhanced usual care. The PACT teamlet will serve as the unit of randomization. EPIC consists of four 1-hour group sessions focusing on 1) The ABCs of Diabetes Care, 2) How to Make Goals and Action Plans, 3) Communication with Your Provider, and 4) Staying Committed to Your Goals & Action Plans. After each group, 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. We will collect laboratory and survey data at baseline, six months, and one year. We 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Veterans receiving primary care at VISN 12 study sites who are enrolled in the panels of participating primary care teams
  • Veterans with ICD-9-CM codes indicating a diagnosis of diabetes
  • Veterans with an average HbA1c level > 8% in the prior 6 months

Exclusion Criteria:

We 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

We 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01876485

Contacts
Contact: LeChauncy D Woodard, MD MPH (713) 794-8613 woodard.lechauncy@va.gov
Contact: Aanand D Naik, MD (713) 794-8541 Aanand.Naik@va.gov

Locations
United States, Texas
Michael E DeBakey VA Medical Center Not yet recruiting
Houston, Texas, United States, 77030
Contact: Lea Kiefer, MPH BA    713-794-8231    lea.kiefer@va.gov   
Contact: Shannon D Underwood, BA    (713) 794-8621    shannon.underwood@va.gov   
Principal Investigator: LeChauncy D. Woodard, MD MPH         
Sponsors and Collaborators
Investigators
Principal Investigator: LeChauncy D. Woodard, MD MPH Michael E DeBakey VA Medical Center
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01876485     History of Changes
Other Study ID Numbers: CRE 12-426
Study First Received: June 10, 2013
Last Updated: July 24, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Diabetes Mellitus
health literacy
patient activation
goals of care

Additional relevant MeSH terms:
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 20, 2014