Clinical trial NCT00481286: Improving Outcomes Using Collaborative Group Clinics to Empower Older Patients
Official title: Improving Outcomes for Multiple Morbidities Using Collaborative Group Clinics to Empower Older Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Hypertension
Keywords: Group clinics
Goal setting
Diabetes
Hypertension
Age 50+
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
name: M.D. Anderson Cancer Center
name: Michael E. DeBakey VA Medical Center
First posted: 2007-06-01
Enrollment: 129
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Change in systolic blood pressure; change in Hemoglobin A1C; change in low density lipoprotein
timeFrame: 12 months
Secondary outcomes:
measure: Attainment of benchmark levels for SBP, A1C, LDL; self-management performance (self-report); completion of group clinic
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Baylor College of Medicine
name: Aanand D Naik, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Teal CR, Haidet P, Balasubramanyam AS, Rodriguez E, Naik AD. Measuring the quality of patients' goals and action plans: development and validation of a novel tool. BMC Med Inform Decis Mak. 2012 Dec 27;12:152. doi: 10.1186/1472-6947-12-152.
citation: Naik AD, Palmer N, Petersen NJ, Street RL Jr, Rao R, Suarez-Almazor M, Haidet P. Comparative effectiveness of goal setting in diabetes mellitus group clinics: randomized clinical trial. Arch Intern Med. 2011 Mar 14;171(5):453-9. doi: 10.1001/archinternmed.2011.70.