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Clinical Decision Support for Women With a History of Gestational Diabetes

Primary Purpose

Gestational Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Quality improvement initiative
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Gestational Diabetes Mellitus focused on measuring Screening, Gestational diabetes mellitus

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention

    Usual care

    Arm Description

    Quality improvement initiative using computerized decision support

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 25, 2010
    Last Updated
    February 3, 2012
    Sponsor
    Brigham and Women's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01288144
    Brief Title
    Clinical Decision Support for Women With a History of Gestational Diabetes
    Official Title
    Clinical Decision Support for Women With a History of Gestational Diabetes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2007 (undefined)
    Primary Completion Date
    November 2011 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Brigham and Women's Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gestational Diabetes Mellitus
    Keywords
    Screening, Gestational diabetes mellitus

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1000 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Quality improvement initiative using computerized decision support
    Arm Title
    Usual care
    Arm Type
    No Intervention
    Arm Description
    In control clinics, women will continue to receive usual care.
    Intervention Type
    Other
    Intervention Name(s)
    Quality improvement initiative
    Other Intervention Name(s)
    Quality improvement initiative using computerized decision support
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Rate of screening
    Description
    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)

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26241263
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

    Clinical Decision Support for Women With a History of Gestational Diabetes

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