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

Phase 2
50 Years
90 Years
Not Enrolling
Diabetes, Hypertension

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Trial Information

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

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Aanand D Naik, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Baylor College of Medicine


United States: Federal Government

Study ID:

7 U18 HS016093



Start Date:

April 2007

Completion Date:

September 2009

Related Keywords:

  • Diabetes
  • Hypertension
  • Group clinics
  • Goal setting
  • Diabetes
  • Hypertension
  • Age 50+
  • Diabetes Mellitus
  • Hypertension