Status:
RECRUITING
Facilitated Transitions From Postpartum to Primary Care Coordination for People With Chronic Conditions
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Harvard School of Public Health (HSPH)
Conditions:
Hypertension
Diabetes
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The lack of postpartum primary care coordination is a missed opportunity to increase primary care engagement and manage chronic conditions early in life, especially for the \>30% of pregnant people wh...
Detailed Description
Over 30% of pregnant people have at least one chronic medical condition, and 20% have certain prenatal conditions (e.g., pregnancy-related hypertension, gestational diabetes) that increase the risk of...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Receiving obstetric care at an MGH-affiliated obstetrics practice (except for the MGH HOPE Clinic, which has a unique care model that provides prenatal and postnatal care for individuals with substance use disorder, including the provision of primary care through 2+ years postpartum)
- Pregnant with a live fetus or delivered a live-born neonate ≥24 weeks of gestation, based on the clinical estimate of gestational age
- If postpartum, has a neonate that is currently living at the time of enrollment
- Has one or more of the following conditions listed in the "Problem List," "Medical History," or clinical notes during prenatal, intrapartum, or postpartum encounters in the EHR (or in the case of BMI, the patient's anthropometric measurements):
- Chronic or essential hypertension
- Hypertensive disorders related to pregnancy (e.g., pre-eclampsia)
- Type 1 or 2 diabetes (i.e., pre-existing diabetes)
- Gestational diabetes
- Class II Obesity (pre-pregnancy body mass index ≥35 kg/m2; or if pre-pregnancy body mass index is not known, a first trimester BMI of ≥35 kg/m2)
- Depression or anxiety disorder
- Has a primary care clinician listed in the patient's medical record
- Has access to or agrees to be enrolled in the electronic health record patient portal and consents to be contacted via these modalities
- Able to read/speak English or Spanish language
- Is age ≥18 years old
- Exclusion Criteria
- • Any individual not meeting all inclusion criteria
Exclusion
Key Trial Info
Start Date :
May 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 23 2028
Estimated Enrollment :
1320 Patients enrolled
Trial Details
Trial ID
NCT06557005
Start Date
May 23 2025
End Date
May 23 2028
Last Update
June 3 2025
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115