Developing and Implementing a Quality Measure for Glycemic Control

Diabetes Clinical Trial

Official title:

Developing and Implementing a Quality Measure for Glycemic Control

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00012675
• Other study ID #: DII 99-205
• Status: Withdrawn
• Phase: N/A
• First received: March 14, 2001
• Last updated: May 23, 2012
• Est. completion date: December 2003

Study information

• Verified date: May 2012
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

Many patients with diabetes are under sub-optimal glycemic control. Central to the clinician's task in improving glycemic control is the management of hypoglycemic medication therapy, including the use of drugs such as insulin and sulfonylureas. Clinical trials have demonstrated that more intensive hypoglycemic medication therapy results in improved glycemic control. Yet quality measures for this critical process of care have not been developed and we know little about how physicians actually manage hypoglycemic medications.

Description:

Background:

Many patients with diabetes are under sub-optimal glycemic control. Central to the clinician's task in improving glycemic control is the management of hypoglycemic medication therapy, including the use of drugs such as insulin and sulfonylureas. Clinical trials have demonstrated that more intensive hypoglycemic medication therapy results in improved glycemic control. Yet quality measures for this critical process of care have not been developed and we know little about how physicians actually manage hypoglycemic medications.

Objectives:

We propose to develop a quality measure that describes the intensity of physicians' hypoglycemic medication therapy. We will then provide feedback to VA physicians regarding their practices and access to experts in diabetes care to determine whether this intervention leads to improvements in glycemic control.

Methods:

The study was divided into two phases. During the first phase we used existing data to model the decision to increase hypoglycemic medications. At each medical visit, we determined whether an increase in medication therapy occurred. We then used recursive partitioning to develop a model that identified patient characteristics at the visit, such as recent laboratory results and diagnoses, associated with the decision to increase therapy. This model assigns a predicted probability of an increase in therapy to each visit. We used these predictions to define an intensity of hypoglycemic medication therapy for each physician that compared the actual to predicted number of increases over all patient-visits. The second phase was a randomized trial in which clinicians at experimental sites receive feedback on performance and access to expert opinion while usual care is provided at control sites. Feedback on performance was provided twice over 6 months. The change in intensity of treatment scores and glycosylated hemoglobin levels pre- and post-intervention at these sites were compared to performance of primary care physicians at control sites not receiving the intervention.

Status:

Completed.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Clinic patients with diabetes

Exclusion Criteria:

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Diabetes

Locations

Country	Name	City	State
United States	Bedford VA Medical Center	Bedford	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (3)

Berlowitz DR, Ash AS, Glickman M, Friedman RH, Pogach LM, Nelson AL, Wong AT. Developing a quality measure for clinical inertia in diabetes care. Health Serv Res. 2005 Dec;40(6 Pt 1):1836-53. — View Citation

Chaudhry SI, Berlowitz DR, Concato J. Do age and comorbidity affect intensity of pharmacological therapy for poorly controlled diabetes mellitus? J Am Geriatr Soc. 2005 Jul;53(7):1214-6. — View Citation

Pugh MJ, Anderson J, Pogach LM, Berlowitz DR. Differential adoption of pharmacotherapy recommendations for type 2 diabetes by generalists and specialists. Med Care Res Rev. 2003 Jun;60(2):178-200. — View Citation