Improving Outcomes Using Collaborative Group Clinics to Empower Older Patients

NCT ID: NCT00481286

Last Updated: 2020-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2009-09-30

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.

Conditions

Diabetes; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Improving outcomes using group clinics for older patients

Intervention Type: BEHAVIORAL

Collaborative group clinics to empower older patients to adopt goal-setting behaviors with their health care providers and improve their diabetes-related outcomes.

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.

Group Type: PLACEBO_COMPARATOR

Standard of Care

Intervention Type: BEHAVIORAL

Standard of care for diabetes patients

Interventions

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.

Intervention Type: BEHAVIORAL

Standard of Care

Standard of care for diabetes patients

Intervention Type: BEHAVIORAL

Other Intervention Names

Diabetes Group Clinic; Goal-setting Clinic; Diabetes usual 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: collaborator

Michael E. DeBakey VA Medical Center

FED

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Aanand Naik

Associate Professor, Medicine-Health Srvcs Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aanand D Naik, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

References

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.

Reference Type: DERIVED

PMID: 23270422 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 21403042 (View on PubMed)

Other Identifiers

7U18HS016093

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

H-20437

Identifier Type: -

Identifier Source: org_study_id