Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00012675
Status:
WITHDRAWN
Last Update Posted:
2012-05-24
First Post:
2001-03-14
Brief Title:
Developing and Implementing a Quality Measure for Glycemic Control
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Developing and Implementing a Quality Measure for Glycemic Control
Status:
WITHDRAWN
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study was withdrawn prior to enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Many patients with diabetes are under sub-optimal glycemic control Central to the clinicians 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 clinicians 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
Many patients with diabetes are under sub-optimal glycemic control Central to the clinicians 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None