Improving Outcomes Using Collaborative Group Clinics to Empower Older Patients (EPIC)

This study has been completed.
Sponsor:
Collaborators:
M.D. Anderson Cancer Center
Michael Debakey Veterans Affairs Medical Center
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00481286
First received: May 31, 2007
Last updated: October 20, 2009
Last verified: October 2009

May 31, 2007
October 20, 2009
April 2007
April 2008   (final data collection date for primary outcome measure)
Change in systolic blood pressure; change in Hemoglobin A1C; change in low density lipoprotein [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Change in systolic blood pressure; change in Hemoglobin A1C; change in low density lipoprotein [ Time Frame: 12 months ]
Complete list of historical versions of study NCT00481286 on ClinicalTrials.gov Archive Site
Attainment of benchmark levels for SBP, A1C, LDL; self-management performance (self-report); completion of group clinic [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Attainment of benchmark levels for SBP, A1C, LDL; self-management performance (self-report); completion of group clinic [ Time Frame: 12 months ]
Not Provided
Not Provided
 
Improving Outcomes Using Collaborative Group Clinics to Empower Older Patients
Improving Outcomes for Multiple Morbidities Using Collaborative Group Clinics to Empower Older Patients

The purpose of this study is to determine if group clinics help older veterans change behaviors with the goal of improving diabetes outcomes.

Among persons aged 55-84 years, over 65% have one to three common medical conditions (e.g., hypertension, diabetes, arthritis, stroke, heart disease, etc.). Fortunately, large randomized clinical trials have demonstrated the effectiveness of treatment and prevention strategies for many chronic conditions (e.g., dietary modification and medications for hypertension, intensive glucose monitoring with diet and medication regimens for diabetes, etc.). Despite the significant findings from numerous clinical trials, most older persons continue to suffer from uncontrolled hypertension, hyperglycemia, and other predictors of poor health outcomes. Non-compliance with clinical guidelines by providers (i.e. clinical inertia) and non-adherence to doctors' recommendations are typically blamed for these unacceptably poor outcomes. For older adults with several conditions, the processes of patient-clinician collaboration are not well understood. Goal-setting behaviors may improve health care by linking desired outcomes (i.e., reduce risk of heart attacks) to the goals of care (i.e., salt restriction for hypertension control). Furthermore, the process of goal-setting may be more effective if patients internalize the importance of a particular goal and prioritize that goal among multiple clinical problems (i.e., hypertension care for patients with diabetes.

Effective methods of implementing collaborative goals and training patients to negotiate shared goals and goal-directed behaviors with their clinicians have been developed for diabetes control. The effectiveness of these methods may be enhanced through the use of clinics that enroll small groups of subjects with rapid follow-up for several weeks. Group clinics have demonstrated improved outcomes for common chronic conditions. Evidence demonstrating the synergistic benefit of efficient group clinics and collaborative goal-setting is limited. However, an approach combining these methodologies may provide an improved method of rapidly controlling multiple chronic conditions and maintaining control of those chronic conditions over a prolonged time period.

To address the gap in the implementation of effective and efficient medical care, we will develop and test a model of collaborative group clinics that empowers older patients to adopt goal-setting behaviors, increases communication with their health care provider, and improves their diabetes-related outcomes. The objectives are to use a collaborative group clinic to: 1) Improve diabetes process of care outcomes over a 3 month time period; 2) Significantly improve the maintenance of diabetes process of care improvements over a 12 month time period; and 3) Significantly improve use of self-management behaviors for diabetes care.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Diabetes
  • Hypertension
  • Behavioral: Improving outcomes using group clinics for older patients
    Collaborative group clinics to empower older patients to adopt goal-setting behaviors with their health care providers and improve their diabetes-related outcomes.
    Other Names:
    • Diabetes Group Clinic
    • Goal-setting Clinic
  • Behavioral: Standard of Care
    Standard of care for diabetes patients
    Other Name: Diabetes usual care
  • Experimental: Group Clinic
    Patients in Group Clinic arm will meet every 3rd week for 12 weeks, for a total of 4 visits. At each visit, BP will be measured, home BP and glucose measurements collected. Each visit will include group-based education and feedback sessions, with an individualized process of selecting and modifying process of care goals for systolic BP, H1C, and LDL cholesterol. Short-term health behavior change goals will also be discussed.
    Intervention: Behavioral: Improving outcomes using group clinics for older patients
  • Placebo Comparator: Uusual Care
    Older diabetes patients will attend regular clinician visits and one targeted primary care physician visit during the 12 weeks post-enrollment. They will be enrolled in a diabetes education class. Blood pressure, H1C and lipids will be measured at enrollment, 6 weeks , and 12 weeks.
    Intervention: Behavioral: Standard of Care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
129
September 2009
April 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of diabetes and hypertension
  • HgA1C value greater than or equal to 7.5
  • Creatinine value less than or equal to 2.0mg/dl
  • SBP greater than or equal to 140

Exclusion Criteria:

  • Prior diagnoses of dementia using ICD-9 codes validated for a VA population
Both
50 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00481286
7 U18 HS016093, RFA HS 05-014
No
Aanand Naik, MD, Baylor College of Medicine
Baylor College of Medicine
  • Agency for Healthcare Research and Quality (AHRQ)
  • M.D. Anderson Cancer Center
  • Michael Debakey Veterans Affairs Medical Center
Principal Investigator: Aanand D Naik, MD Baylor College of Medicine
Baylor College of Medicine
October 2009

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