Clinical trial NCT00012675: Developing and Implementing a Quality Measure for Glycemic Control
Official title: Developing and Implementing a Quality Measure for Glycemic Control
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Diabetes
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-03-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

Clinic patients with diabetes

Exclusion Criteria:

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bedford
country: United States
facility: Bedford VA Medical Center
state: Massachusetts
Study officials:
affiliation: Bedford VA Medical Center
name: Dan R. Berlowitz, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1111/j.1475-6773.2005.00436.x.
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. doi: 10.1111/j.1532-5415.2005.53370.x.
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. doi: 10.1177/1077558703060002003.