View Clinical Trial (Medical Research Study)
Improving Risk Factors for Diabetes Complications in Primary Care
| City: |
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San Antonio |
| State: |
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Texas |
| Zip Code: |
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78229 |
| Conditions: |
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Diabetes Mellitus, Non-Insulin-Dependent |
| Purpose: |
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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
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| Study Summary: |
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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.
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| 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
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| NCT ID: |
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NCT00482768 |
| Primary Contact: |
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Principal Investigator
Michael L Parchman, MD, MPH
University of Texas Health Science Center-San Antonio
Michael L Parchman, MD, MPH
Phone: 210 617-5314
Email: parchman@uthscsa.edu
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| Backup Contact: |
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Email: romeror0@uthscsa.edu
Raquel L Romero, MD, MPH
Phone: 210 617-5232
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| Location Contact: |
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San Antonio, Texas 78229
United States
Michael L Parchman, MD, MPH
Phone: 210-617-5314
Email: parchman@uthscsa.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
| Modifications to this listing: |
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