Improving Outcomes Using Collaborative Group Clinics to Empower Older Patients (EPIC)
| Tracking Information | |||||
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| First Received Date ICMJE | May 31, 2007 | ||||
| Last Updated Date | October 20, 2009 | ||||
| Start Date ICMJE | April 2007 | ||||
| Primary Completion Date | April 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Change in systolic blood pressure; change in Hemoglobin A1C; change in low density lipoprotein [ Time Frame: 12 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Change in systolic blood pressure; change in Hemoglobin A1C; change in low density lipoprotein [ Time Frame: 12 months ] | ||||
| Change History | Complete list of historical versions of study NCT00481286 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Attainment of benchmark levels for SBP, A1C, LDL; self-management performance (self-report); completion of group clinic [ Time Frame: 12 months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Attainment of benchmark levels for SBP, A1C, LDL; self-management performance (self-report); completion of group clinic [ Time Frame: 12 months ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Improving Outcomes Using Collaborative Group Clinics to Empower Older Patients | ||||
| Official Title ICMJE | Improving Outcomes for Multiple Morbidities Using Collaborative Group Clinics to Empower Older Patients | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 129 | ||||
| Completion Date | September 2009 | ||||
| Primary Completion Date | April 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 50 Years to 90 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00481286 | ||||
| Other Study ID Numbers ICMJE | 7 U18 HS016093, RFA HS 05-014 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Aanand Naik, MD, Baylor College of Medicine | ||||
| Study Sponsor ICMJE | Baylor College of Medicine | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Baylor College of Medicine | ||||
| Verification Date | October 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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