NCT01288144

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2010

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 2, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Last Updated

February 6, 2012

Status Verified

February 1, 2012

Enrollment Period

4.3 years

First QC Date

August 25, 2010

Last Update Submit

February 3, 2012

Conditions

Keywords

ScreeningGestational diabetes mellitus

Outcome Measures

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.

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

Study Arms (2)

Intervention

EXPERIMENTAL

Quality improvement initiative using computerized decision support

Other: Quality improvement initiative

Usual care

NO INTERVENTION

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

Interventions

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
Intervention

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

August 25, 2010

First Posted

February 2, 2011

Study Start

July 1, 2007

Primary Completion

November 1, 2011

Last Updated

February 6, 2012

Record last verified: 2012-02