Improving Risk Factors for Diabetes Complications in Primary Care

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00482768
First received: June 4, 2007
Last updated: March 15, 2011
Last verified: March 2011

June 4, 2007
March 15, 2011
June 2007
April 2012   (final data collection date for primary outcome measure)
glycosolated hemoglobin [ Time Frame: 36 months ] [ Designated as safety issue: No ]
glycosolated hemoglobin [ Time Frame: 36 months ]
Complete list of historical versions of study NCT00482768 on ClinicalTrials.gov Archive Site
  • systolic blood pressure [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • LDL-cholesterol [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Change in risk of coronary heart disease [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • systolic blood pressure [ Time Frame: 36 months ]
  • LDL-cholesterol [ Time Frame: 36 months ]
  • Change in risk of coronary heart disease [ Time Frame: 36 months ]
Not Provided
Not Provided
 
Improving Risk Factors for Diabetes Complications in Primary Care
Improving Risk Factors for Diabetes Complications in Primary Care

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

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Diabetes Mellitus, Non-Insulin-Dependent
Behavioral: Practice Facilitation
Clinics in the experimental arm will meet with a trained facilitator to work on change strategies that will improve risk factors for diabetes complications.
  • Experimental: 1
    Intervention clinics will receive practice facilitation visits at regular intervals over a 12-month period.
    Intervention: Behavioral: Practice Facilitation
  • No Intervention: 2
    Control clinics will deliver usual care for patients with diabetes.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2400
April 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
Not Provided
Yes
Contact: Michael L Parchman, MD, MPH 210 617-5314 parchman@uthscsa.edu
Contact: Raquel L Romero, MD, MPH 210 617-5232 romeror0@uthscsa.edu
United States
 
NCT00482768
R18 DK75692
Yes
Michael L. Parchman, MD, University of Texas Health Science Center at San Antonio
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Not Provided
Principal Investigator: Michael L Parchman, MD, MPH University of Texas Health Science Center-San Antonio
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP