Improving Risk Factors for Diabetes Complications in Pr...

Improving Risk Factors for Diabetes Complications in Primary Care

Improving Risk Factors for Diabetes Complications in Primary Care
ClinicalTrials.gov

This study is currently recruiting participants.
Verified by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), June 2008

Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00482768

Purpose
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 Intervention
Type 2 Diabetes Behavioral: Practice Facilitation

MedlinePlus related topics: Cholesterol Diabetes Diabetes Complications

U.S. FDA Resources
Study Type: Interventional
Study Design: Health Services Research, Randomized, Open Label, Placebo Control, Crossover Assignment
Official Title: Improving Risk Factors for Diabetes Complications in Primary Care

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:

* glycosolated hemoglobin [ Time Frame: 36 months ] [ Designated as safety issue: No ]


Secondary Outcome Measures:

* 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 ]


Estimated Enrollment: 2400
Study Start Date: June 2007
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Intervention clinics will Behavioral: Practice Facilitation
receive practice facilitation Clinics in the experimental arm will meet
visits at regular intervals with a trained facilitator to work on
over a 12-month period. change strategies that will improve risk
factors for diabetes complications.


2: No Intervention
Control clinics will deliver
usual care for patients with
diabetes.


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.

Eligibility
Genders Eligible for Study: Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00482768

Contacts
Contact: Michael L Parchman, MD, MPH 210 617-5314 parchman@uthscsa.edu
Contact: Raquel L Romero, MD, MPH 210 617-5232 romeror0@uthscsa.edu

Locations
United States, Texas
University of Texas Health Sciences Center Recruiting
San Antonio, Texas, United States, 78229-4404
Contact: Michael L Parchman, MD, MPH 210-617-5314 parchman@uthscsa.edu
Contact: Raquel L Romero, MD, MPH 210 617-5232 romeror0@uthscsa.edu

Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators
Principal Investigator: Michael L Parchman, MD, MPH University of Texas Health Science Center-San Antonio
More Information


Responsible Party: University of Texas Health Science Center at San Antonio ( Michael L. Parchman, MD )
Study ID Numbers: DK75692
First Received: June 4, 2007
Last Updated: June 19, 2008
ClinicalTrials.gov Identifier: NCT00482768
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Diabetes, type II; Primary Health Care; Outpatient Care

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Diabetes Complications

ClinicalTrials.gov processed this record on December 14, 2008