Clinical Decision Support for Women With a History of Gestational Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01288144
Recruitment Status : Completed
First Posted : February 2, 2011
Last Update Posted : February 6, 2012
Information provided by (Responsible Party):
Ellen W. Seely, Brigham and Women's Hospital

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.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Mellitus Other: Quality improvement initiative Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Clinical Decision Support for Women With a History of Gestational Diabetes
Study Start Date : July 2007
Actual Primary Completion Date : November 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Intervention
Quality improvement initiative using computerized decision support
Other: Quality improvement initiative
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.
Other Name: Quality improvement initiative using computerized decision support

No Intervention: Usual care
In control clinics, women will continue to receive usual care.

Primary Outcome Measures :
  1. Rate of screening [ Time Frame: 1 year following implementation at all sites (Nov. 2011) ]

    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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


Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Ellen W. Seely, M.D., Brigham and Women's Hospital Identifier: NCT01288144     History of Changes
Other Study ID Numbers: 2007p000842
First Posted: February 2, 2011    Key Record Dates
Last Update Posted: February 6, 2012
Last Verified: February 2012

Keywords provided by Ellen W. Seely, Brigham and Women's Hospital:
Gestational diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications