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

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ClinicalTrials.gov Identifier: NCT01876485
Recruitment Status : Completed
First Posted : June 12, 2013
Last Update Posted : March 12, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

June 10, 2013
June 12, 2013
March 12, 2018
July 13, 2015
February 9, 2018   (Final data collection date for primary outcome measure)
Changes in Hemoglobin A1c levels during intervention [ Time Frame: Hemoglobin A1c levels will be measured at baseline, four months, and ten months. ]
Measures of Hemoglobin A1c will be taken to assess average blood glucose levels throughout the study as an indicator of diabetes control.
Changes in Hemoglobin A1c levels during intervention [ Time Frame: Hemoglobin A1c levels will be measured at baseline, six months, and one year. ]
Measures of Hemoglobin A1c will be taken to assess average blood glucose levels throughout the study as an indicator of diabetes control.
Complete list of historical versions of study NCT01876485 on ClinicalTrials.gov Archive Site
  • Change in diabetes specific quality of life [ Time Frame: Diabetes specific quality of life will be measured at baseline, four months, and ten months. ]
    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. ]
    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, four months, and ten months. ]
    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, four months, and ten months. ]
    This measure is a part of our broader mediators and moderators analysis within our proposed conceptual model.
  • Change in diabetes specific quality of life [ Time Frame: Diabetes specific quality of life will be measured at baseline, six months, and one year. ]
    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. ]
    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. ]
    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. ]
    This measure is a part of our broader mediators and moderators analysis within our proposed conceptual model.
Not Provided
Not Provided
 
Point-of-care Health Literacy and Activation Information to Improve Diabetes Care
Point-of-care Health Literacy and Activation Information to Improve Diabetes Care
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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Diabetes Mellitus
  • Behavioral: Empowering Patients in Chronic Care (EPIC)
    EPIC group training sessions consisting of 6 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: Enhanced Usual Care (EUC)
    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.
  • Experimental: Arm 1: Empowering Patients in Chronic Care (EPIC)
    Patients in the intervention arm will receive the Empowering Patients in Chronic Care group training sessions consisting of 6 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.
    Intervention: Behavioral: Empowering Patients in Chronic Care (EPIC)
  • Active Comparator: Arm 2: Enhanced Usual Care (EUC)
    The Enhanced Usual Care (EUC) arm will serve as a concurrent control group to compare to the intervention arm of the study. 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.
    Intervention: Behavioral: Enhanced Usual Care (EUC)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
280
370
February 9, 2018
February 9, 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01876485
CRE 12-426
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Plan to Share IPD: No
VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: LeChauncy D. Woodard, MD MPH Michael E. DeBakey VA Medical Center, Houston, TX
VA Office of Research and Development
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP