ClinicalTrials.gov
ClinicalTrials.gov Menu

Improving Risk Factors for Diabetes Complications in Primary Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00482768
Recruitment Status : Completed
First Posted : June 5, 2007
Last Update Posted : March 19, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: Practice Facilitation Not Applicable

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  (Clinical Trial)
Actual Enrollment : 2493 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Improving Risk Factors for Diabetes Complications in Primary Care
Study Start Date : June 2007
Actual Primary Completion Date : April 2012
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Intervention clinics will receive practice facilitation visits at regular intervals over a 12-month period.
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.
No Intervention: 2
Control clinics will deliver usual care for patients with diabetes.



Primary Outcome Measures :
  1. glycosylated hemoglobin [ Time Frame: 36 months ]

Secondary Outcome Measures :
  1. systolic blood pressure [ Time Frame: 36 months ]
  2. LDL-cholesterol [ Time Frame: 36 months ]
  3. Change in risk of coronary heart disease [ Time Frame: 36 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00482768


Locations
United States, Texas
University of Texas Health Sciences Center
San Antonio, Texas, United States, 78229-4404
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Polly H Noel, PhD University of Texas Health Science Center-San Antonio

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00482768     History of Changes
Other Study ID Numbers: R18DK075692 ( U.S. NIH Grant/Contract )
First Posted: June 5, 2007    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2011

Keywords provided by The University of Texas Health Science Center at San Antonio:
Diabetes, type II; Primary Health Care; Outpatient Care

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Complications
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases