Clinical Decision Support for Women With a History of Gestational Diabetes

Gestational Diabetes Mellitus Clinical Trial

Official title:

Clinical Decision Support for Women With a History of Gestational Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01288144
• Other study ID #: 2007p000842
• Status: Completed
• Phase: N/A
• First received: August 25, 2010
• Last updated: February 3, 2012
• Start date: July 2007

Study information

• Verified date: February 2012
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No