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Clinical Decision Support for Women With a History of Gestational Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ellen W. Seely, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01288144
First received: August 25, 2010
Last updated: February 3, 2012
Last verified: February 2012
  Purpose

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 Intervention
Gestational Diabetes Mellitus
Other: Quality improvement initiative

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Clinical Decision Support for Women With a History of Gestational Diabetes

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Rate of screening [ Time Frame: 1 year following implementation at all sites (Nov. 2011) ] [ Designated as safety issue: No ]

    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.



Enrollment: 1000
Study Start Date: July 2007
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Ellen W. Seely, M.D., Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01288144     History of Changes
Other Study ID Numbers: 2007p000842
Study First Received: August 25, 2010
Last Updated: February 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Screening
Gestational diabetes mellitus

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

ClinicalTrials.gov processed this record on November 24, 2014