Gestational Diabetes MellitusNCT01288144
Clinical Decision Support for Women With a History of Gestational Diabetes
A study testing Quality improvement initiative in people with Gestational Diabetes Mellitus, run by Brigham and Women's Hospital.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Gestational Diabetes Mellitus
- What is being tested?
- Quality improvement initiative
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
About this study
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.
Read more
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.
- Conditions
- Gestational Diabetes Mellitus
- Being tested
- Quality improvement initiative
- Keywords
- Screening, Gestational diabetes mellitus
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality improvement initiativeOther
Also called Quality improvement initiative using computerized decision support
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Quality improvement initiative using computerized decision support Receives: Other: Quality improvement initiative |
| Usual care | No intervention | In control clinics, women will continue to receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year following implementation at all sites (Nov. 2011)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2011 (estimated)
- Study startJul 2007
- Primary completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ellen W. Seely, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01288144
- Sponsor's protocol ID
- 2007p000842
- Status last verified
- Feb 2012
- First submitted
- 25 Aug 2010
- Last updated
- 6 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Decision Support for Women With a History of Gestational Diabetes
- ClinicalTrials.gov ID
- NCT01288144
- Acronym / sponsor ID
- 2007p000842
- Conditions
- Gestational Diabetes Mellitus
- Keywords
- Screening, Gestational diabetes mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Nov 2011 (actual)
- First posted
- 2 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Quality improvement initiativeQuality improvement initiative using computerized decision support |
| Usual care | No intervention | –In control clinics, women will continue to receive usual care. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality improvement initiativeAlso: Quality improvement initiative using computerized decision supportIn 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 | Intervention |
Primary outcome
Rate of screening
Time frame: 1 year following implementation at all sites (Nov. 2011)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2012.
- Derived from this study: PubMed 26241263Zera 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Quality improvement initiative in people with Gestational Diabetes Mellitus, run by Brigham and Women's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of screening (time frame: 1 year following implementation at all sites (Nov. 2011)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01288144, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2012.