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WithdrawnNCT00012675Updated May 24, 2012

Developing and Implementing a Quality Measure for Glycemic Control

An observational study in Diabetes, sponsored by US Department of Veterans Affairs. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-05-24.

Sponsored by US Department of Veterans Affairs · Observational

Why this study was withdrawn
This study was withdrawn prior to enrollment.
Study type
Observational
Time perspective
Retrospective
Enrollment
0
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diabetes
03

In context

Lead sponsor

US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Clinic patients with diabetes

Exclusion criteria

Exclusion Criteria:

05

Study design

Time perspective
Retrospective
Enrollment
0 participants (actual)

Groups and cohorts

  • Group 1
06

Study locations

1 site
  • Bedford VA Medical Center
    Bedford, Massachusetts 01730, United States
07

References and documents

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. PubMed 16336551 ↗
  • 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. PubMed 16108941 ↗
  • 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. PubMed 12800683 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 24, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00012675
Lead sponsor
US Department of Veterans Affairs
Responsible party
Sponsor
First posted
Mar 16, 2001
Completion
Dec 2003
Last update
May 24, 2012

Study contacts

Dan R. Berlowitz, MD MPH
principal investigator · Bedford VA Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in May 2012. You cannot join it, but the record below documents what was studied.

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