Improving Risk Factors for Diabetes Complications in Primary Care

Study Overview
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Brief Summary
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The purpose of this study is to test an intervention in primary care clinics to improve three risk factors for diabetes complications: glucose control, blood pressure and cholesterol. Subjects in the study will be clinic staff and clinicians, not patients. The intervention is Practice Facilitation. Practice facilitation occurs when a trained facilitator meets with a team of staff and clinicians in each practice over a period of several months. Facilitation meetings create time for learning and reflection by members of the team and improves their communication so that they can adopt and implement a strategy to improve patient care

Detailed Description
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Current control of hemoglobin A1c, blood pressure and lipids among patients with type 2 diabetes in primary care settings is not adequate to prevent complications. Results from an NIDDK funded R34 pilot study conducted by members of this research team suggest that Practice Facilitation is feasible and may improve these risk factors. Practice facilitation occurs when a trained facilitator meets with a team of staff and clinicians in each practice over a period of several months. Facilitation meetings create time for learning and reflection by members of the team and improves their communication so that they can adopt and implement a strategy to improve patient care. The purpose of this study is to use a Practice Facilitation intervention to improve the above three risk factors among patients with type 2 diabetes in small, autonomous primary care practices. This intervention is based on complex adaptive system theory to support the selection, tailoring and implementation of one or more strategies to improve the above 3 risk factors in each intervention practice. Five strategies will be discussed during the facilitation to stimulate change in each practice: a diabetes registry, point-of-care testing of HbA1c and lipids, group clinic visits, improved decision support during the visit, and patient activation prior to each visit. The specific objectives are : 1) To evaluate the effectiveness and sustainability of practice facilitation to improve risk factors for type 2 diabetes complications across a variety of primary care settings; 2) Assess the implementation of the chronic care model(CCM) in response to the intervention; 3) Examine the relationship between communication within the practice team and the implementation of the CCM model; and 4) From the perspective of the organization conducting the intervention and the primary care practice, examine the cost of implementing the intervention relative to risk factor change. The study will be a cluster randomized trial conducted in 40 primary care practices randomized to intervention or control. Data will be collected on all practices and 40 patients in each practice using a multi-method assessment process at baseline, 12 and 24 months. The intervention will be a series of 15 visits to 20 intervention practices by trained facilitators over 12 months. Primary hypotheses will be tested with 12 month outcome data. Sustainability of the intervention will be tested with 24 month data. Insights will be included in a delayed intervention conducted in control practices and evaluated in a pre-post design.

Official Title
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Improving Risk Factors for Diabetes Complications in Primary Care

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Practice Facilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary care practice with 5 or fewer physicians The practice must have seen at least 50 patients with type 2 diabetes in the past 90 days Exclusion Criteria: Practice owned by a large vertically integrated health care system
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Intervention clinics will receive practice facilitation visits at regular intervals over a 12-month period. | Behavioral: Practice Facilitation<br>* Clinics in the experimental arm will meet with a trained facilitator to work on change strategies that will improve risk factors for diabetes complications.<br>|
| No Intervention: 2<br>Control clinics will deliver usual care for patients with diabetes. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glycosylated hemoglobin |  | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| systolic blood pressure |  | 36 months | 
| LDL-cholesterol |  | 36 months | 
| Change in risk of coronary heart disease |  | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, type II; Primary Health Care; Outpatient Care