Improving Risk Factors for Diabetes Complications in Primary Care
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Practice Facilitation
Sponsored by
About this trial
This is an interventional health services research trial for Type 2 Diabetes focused on measuring Diabetes, type II; Primary Health Care; Outpatient Care
Eligibility Criteria
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
Sites / Locations
- University of Texas Health Sciences Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
Intervention clinics will receive practice facilitation visits at regular intervals over a 12-month period.
Control clinics will deliver usual care for patients with diabetes.
Outcomes
Primary Outcome Measures
glycosylated hemoglobin
Secondary Outcome Measures
systolic blood pressure
LDL-cholesterol
Change in risk of coronary heart disease
Full Information
NCT ID
NCT00482768
First Posted
June 4, 2007
Last Updated
March 15, 2018
Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT00482768
Brief Title
Improving Risk Factors for Diabetes Complications in Primary Care
Official Title
Improving Risk Factors for Diabetes Complications in Primary Care
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Diabetes, type II; Primary Health Care; Outpatient Care
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2493 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Intervention clinics will receive practice facilitation visits at regular intervals over a 12-month period.
Arm Title
2
Arm Type
No Intervention
Arm Description
Control clinics will deliver usual care for patients with diabetes.
Intervention Type
Behavioral
Intervention Name(s)
Practice Facilitation
Intervention Description
Clinics in the experimental arm will meet with a trained facilitator to work on change strategies that will improve risk factors for diabetes complications.
Primary Outcome Measure Information:
Title
glycosylated hemoglobin
Time Frame
36 months
Secondary Outcome Measure Information:
Title
systolic blood pressure
Time Frame
36 months
Title
LDL-cholesterol
Time Frame
36 months
Title
Change in risk of coronary heart disease
Time Frame
36 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Polly H Noel, PhD
Organizational Affiliation
University of Texas Health Science Center-San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Health Sciences Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-4404
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18321386
Citation
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.
Results Reference
background
PubMed Identifier
22310483
Citation
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.
Results Reference
background
PubMed Identifier
22335375
Citation
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.
Results Reference
background
PubMed Identifier
23690319
Citation
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.
Results Reference
background
PubMed Identifier
22264426
Citation
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.
Results Reference
background
PubMed Identifier
22186171
Citation
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.
Results Reference
background
PubMed Identifier
23965255
Citation
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.
Results Reference
result
PubMed Identifier
24678983
Citation
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.
Results Reference
derived
Learn more about this trial
Improving Risk Factors for Diabetes Complications in Primary Care
We'll reach out to this number within 24 hrs