Clinical Decision Support for Women With a History of Gestational Diabetes
Primary Purpose
Gestational Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Quality improvement initiative
Sponsored by
About this trial
This is an interventional screening trial for Gestational Diabetes Mellitus focused on measuring Screening, Gestational diabetes mellitus
Eligibility Criteria
Inclusion:
- Primary care clinic (gynecology, internal medicine, community health center)
- Use longitudinal medical record (LMR) program for documentation
- Previously participated in rct of decision support intervention
Exclusion:
- None
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Usual care
Arm Description
Quality improvement initiative using computerized decision support
In control clinics, women will continue to receive usual care.
Outcomes
Primary Outcome Measures
Rate of screening
The American Diabetes Association recommends that women with a history of GDM undergo glucose screening at 6 weeks post partum. Women with normal postpartum glucose testing should receive follow-up testing every three years, and those with impaired glucose tolerance should receive annual follow-up screening.
Our study will evaluate a quality improvement intervention to increase the number of women who are appropriately identified and undergo screening.
Secondary Outcome Measures
Full Information
NCT ID
NCT01288144
First Posted
August 25, 2010
Last Updated
February 3, 2012
Sponsor
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01288144
Brief Title
Clinical Decision Support for Women With a History of Gestational Diabetes
Official Title
Clinical Decision Support for Women With a History of Gestational Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators hypothesize that computer-assisted decision support will increase the percentage of women with a history of gestational diabetes who receive appropriate follow-up screening.
Specific Aim 1: Develop an algorithm to identify cases of gestational diabetes among patients in the Partners Health Care system using administrative and laboratory data.
Specific Aim 2: Assess primary care provider knowledge, attitudes, beliefs, and barriers to compliance regarding screening guidelines for women with a history of gestational diabetes.
Specific Aim 3: Test whether a computer-assisted decision support tool to identify patients with a GDM history and prompt screening will increase compliance with guidelines. The investigators hypothesize that decision support will significantly increase in the percentage of women screened.
Detailed Description
Approximately 5 percent of women are diagnosed with gestational diabetes (GDM) during pregnancy. These women face an increased risk of progression to type 2 diabetes1 and may benefit from lifestyle interventions and screening to detect early disease. However, studies have shown that less than half of women are screened appropriately in the postpartum period. This performance gap may reflect both lack of communication between obstetric and primary care providers and lack of knowledge of appropriate screening guidelines. The investigators plan to assess a quality improvement initiative, using administrative and clinical data, to identify women with a history of GDM and implement decision support to enhance quality of care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus
Keywords
Screening, Gestational diabetes mellitus
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Quality improvement initiative using computerized decision support
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
In control clinics, women will continue to receive usual care.
Intervention Type
Other
Intervention Name(s)
Quality improvement initiative
Other Intervention Name(s)
Quality improvement initiative using computerized decision support
Intervention Description
In intervention clinics, the LMR will use the existing reminder function to alert providers that a patient has a probable history of gestational diabetes. The provider will then have the opportunity to clarify the subject's history and order appropriate screening testing. Providers will also have access to online reference material regarding GDM follow-up screening and lifestyle interventions.
Primary Outcome Measure Information:
Title
Rate of screening
Description
The American Diabetes Association recommends that women with a history of GDM undergo glucose screening at 6 weeks post partum. Women with normal postpartum glucose testing should receive follow-up testing every three years, and those with impaired glucose tolerance should receive annual follow-up screening.
Our study will evaluate a quality improvement intervention to increase the number of women who are appropriately identified and undergo screening.
Time Frame
1 year following implementation at all sites (Nov. 2011)
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion:
Primary care clinic (gynecology, internal medicine, community health center)
Use longitudinal medical record (LMR) program for documentation
Previously participated in rct of decision support intervention
Exclusion:
None
12. IPD Sharing Statement
Citations:
PubMed Identifier
26241263
Citation
Zera CA, Bates DW, Stuebe AM, Ecker JL, Seely EW. Diabetes Screening Reminder for Women With Prior Gestational Diabetes: A Randomized Controlled Trial. Obstet Gynecol. 2015 Jul;126(1):109-14. doi: 10.1097/AOG.0000000000000883.
Results Reference
derived
Learn more about this trial
Clinical Decision Support for Women With a History of Gestational Diabetes
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