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CompletedNCT01288144Updated Feb 6, 2012

Clinical Decision Support for Women With a History of Gestational Diabetes

An interventional study of Quality improvement initiative in Gestational Diabetes Mellitus, sponsored by Brigham and Women's Hospital. Completed. Open to female participants. Per ClinicalTrials.gov, last updated 2012-02-06.

Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
1,000
Allocation
Randomized
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Gestational Diabetes Mellitus

Keywords

  • Screening
  • Gestational diabetes mellitus
03

In context

Diabetes, Gestational

842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.

This study's enrollment of 1,000 is above the median of 110 across 550 interventional studies indexed under Diabetes, Gestational.

Browse Diabetes, Gestational studies →

Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.

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

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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 criteria

Exclusion:

  • None
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,000 participants (actual)

Study arms

  • Experimental
    Intervention

    Quality improvement initiative using computerized decision support

    Other: Quality improvement initiative

  • No intervention
    Usual care

    In control clinics, women will continue to receive usual care.

Interventions

  • OtherQuality 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.

    Also known as: Quality improvement initiative using computerized decision support

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year following implementation at all sites (Nov. 2011)

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 26241263 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01288144
Lead sponsor
Brigham and Women's Hospital
Responsible party
Ellen W. Seely (M.D., Brigham and Women's Hospital) — Principal investigator
First posted
Feb 2, 2011
Start date
Jul 2007
Primary completion
Nov 2011
Last update
Feb 6, 2012

Oversight

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

Not currently enrolling

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

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