- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00012675
Developing and Implementing a Quality Measure for Glycemic Control
Study Overview
Status
Conditions
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.
Study Type
Contacts and Locations
Study Locations
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Massachusetts
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Bedford, Massachusetts, United States, 01730
- Bedford VA Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Clinic patients with diabetes
Exclusion Criteria:
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Group 1
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Collaborators and Investigators
Investigators
- Principal Investigator: Dan R. Berlowitz, MD MPH, Bedford VA Medical Center
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- DII 99-205
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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