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
  Purpose

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


Condition Intervention Phase
Diabetes
Hypertension
Behavioral: Improving outcomes using group clinics for older patients
Behavioral: Standard of Care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Improving Outcomes for Multiple Morbidities Using Collaborative Group Clinics to Empower Older Patients

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Change in systolic blood pressure; change in Hemoglobin A1C; change in low density lipoprotein [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 129
Study Start Date: April 2007
Study Completion Date: September 2009
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
Behavioral: Standard of Care
Standard of care for diabetes patients
Other Name: Diabetes usual care

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00481286

Sponsors and Collaborators
Baylor College of Medicine
M.D. Anderson Cancer Center
Michael Debakey Veterans Affairs Medical Center
Investigators
Principal Investigator: Aanand D Naik, MD Baylor College of Medicine
  More Information

No publications provided by Baylor College of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Aanand Naik, MD, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00481286     History of Changes
Other Study ID Numbers: 7 U18 HS016093, RFA HS 05-014
Study First Received: May 31, 2007
Last Updated: October 20, 2009
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
Group clinics
Goal setting
Diabetes
Hypertension
Age 50+

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

ClinicalTrials.gov processed this record on August 01, 2014