- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00482768
Improving Risk Factors for Diabetes Complications in Primary Care
March 15, 2018 updated by: The University of Texas Health Science Center at San Antonio
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
2493
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
San Antonio, Texas, United States, 78229-4404
- University of Texas Health Sciences Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Intervention clinics will receive practice facilitation visits at regular intervals over a 12-month period.
|
Clinics in the experimental arm will meet with a trained facilitator to work on change strategies that will improve risk factors for diabetes complications.
|
No Intervention: 2
Control clinics will deliver usual care for patients with diabetes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
glycosylated hemoglobin
Time Frame: 36 months
|
36 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
systolic blood pressure
Time Frame: 36 months
|
36 months
|
LDL-cholesterol
Time Frame: 36 months
|
36 months
|
Change in risk of coronary heart disease
Time Frame: 36 months
|
36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Polly H Noel, PhD, University of Texas Health Science Center-San Antonio
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Parchman ML, Pugh JA, Culler SD, Noel PH, Arar NH, Romero RL, Palmer RF. A group randomized trial of a complexity-based organizational intervention to improve risk factors for diabetes complications in primary care settings: study protocol. Implement Sci. 2008 Mar 5;3:15. doi: 10.1186/1748-5908-3-15.
- Noel PH, Lanham HJ, Palmer RF, Leykum LK, Parchman ML. The importance of relational coordination and reciprocal learning for chronic illness care within primary care teams. Health Care Manage Rev. 2013 Jan-Mar;38(1):20-8. doi: 10.1097/HMR.0b013e3182497262.
- Bowers KW, Robertson M, Parchman ML. How inclusive leadership can help your practice adapt to change. Fam Pract Manag. 2012 Jan-Feb;19(1):8-11. No abstract available.
- Culler SD, Parchman ML, Lozano-Romero R, Noel PH, Lanham HJ, Leykum LK, Zeber JE. Cost estimates for operating a primary care practice facilitation program. Ann Fam Med. 2013 May-Jun;11(3):207-11. doi: 10.1370/afm.1496.
- Mackey K, Parchman ML, Leykum LK, Lanham HJ, Noel PH, Zeber JE. Impact of the Chronic Care Model on medication adherence when patients perceive cost as a barrier. Prim Care Diabetes. 2012 Jul;6(2):137-42. doi: 10.1016/j.pcd.2011.12.004. Epub 2012 Jan 20.
- Arar NH, Noel PH, Leykum L, Zeber JE, Romero R, Parchman ML. Implementing quality improvement in small, autonomous primary care practices: implications for the patient-centred medical home. Qual Prim Care. 2011;19(5):289-300.
- Parchman ML, Noel PH, Culler SD, Lanham HJ, Leykum LK, Romero RL, Palmer RF. A randomized trial of practice facilitation to improve the delivery of chronic illness care in primary care: initial and sustained effects. Implement Sci. 2013 Aug 22;8:93. doi: 10.1186/1748-5908-8-93.
- Noel PH, Parchman ML, Palmer RF, Romero RL, Leykum LK, Lanham HJ, Zeber JE, Bowers KW. Alignment of patient and primary care practice member perspectives of chronic illness care: a cross-sectional analysis. BMC Fam Pract. 2014 Mar 29;15:57. doi: 10.1186/1471-2296-15-57.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Actual)
April 1, 2012
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
June 4, 2007
First Submitted That Met QC Criteria
June 4, 2007
First Posted (Estimate)
June 5, 2007
Study Record Updates
Last Update Posted (Actual)
March 19, 2018
Last Update Submitted That Met QC Criteria
March 15, 2018
Last Verified
March 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R18DK075692 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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