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Completed

NCT Number: NCT00481286

Improving Outcomes 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.

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Key information

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Improving outcomes using group clinics for older patients

Behavioral

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

Standard of Care

Behavioral

Standard of care for diabetes patients

Other names: Diabetes usual care

Primary outcomes

  1. Change in systolic blood pressure; change in Hemoglobin A1C; change in low density lipoprotein

    Time frame: 12 months

    Change in systolic blood pressure; change in Hemoglobin A1C; change in low

Secondary outcomes

  1. Attainment of benchmark levels for SBP, A1C, LDL; self-management performance (self-report); completion of group clinic

    Time frame: 12 months

    Attainment of benchmark levels for SBP, A1C, LDL; self-management

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)
  • M.D. Anderson Cancer Center
  • Michael E. DeBakey VA Medical Center

Registry information

Official study title

Improving Outcomes for Multiple Morbidities Using Collaborative Group Clinics to Empower Older Patients

Acronym: EPIC

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Jun 1, 2007
Registry last updated
Mar 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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