Improving Outcomes Using Collaborative Group Clinics to Empower Older Patients

Hypertension Clinical Trial

— EPIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00481286
• Other study ID #: H-20437
• Secondary ID: 7U18HS016093
• Status: Completed
• Phase: N/A
• Start date: April 2007
• Est. completion date: September 2009

Study information

• Verified date: October 2009
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: September 2009
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Hypertension

Intervention

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.
• Standard of Care
Standard of care for diabetes patients

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Baylor College of Medicine	Agency for Healthcare Research and Quality (AHRQ), M.D. Anderson Cancer Center, Michael Debakey Veterans Affairs Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in systolic blood pressure; change in Hemoglobin A1C; change in low density lipoprotein	Change in systolic blood pressure; change in Hemoglobin A1C; change in low	12 months
Secondary	Attainment of benchmark levels for SBP, A1C, LDL; self-management performance (self-report); completion of group clinic	Attainment of benchmark levels for SBP, A1C, LDL; self-management	12 months