NCT06557005 Facilitated Transitions From Postpartum to Primary Care Coordination for People With Chronic Conditions
| NCT ID | NCT06557005 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,320 participants |
| Start Date | 2025-05-23 |
| Primary Completion | 2027-05-23 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,320 participants in total. It began in 2025-05-23 with a primary completion date of 2027-05-23.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 who have or are at risk for these conditions. This study aims to increase postpartum primary care engagement, quality, and experience by strengthening postpartum transitions to primary care using a behavioral economics-informed, multi-component intervention integrated into usual inpatient postpartum care. Using a randomized controlled trial and repeated outcome assessments through administrative and survey data, this study will generate rigorous, actionable evidence to ensure primary care coordination becomes standard postpartum care practice, potentially catalyzing sustained primary care engagement throughout life.
Eligibility Criteria
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
Contact & Investigator
Mark A Clapp, MD, MPH
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT06557005 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06557005 currently recruiting?
Yes, NCT06557005 is actively recruiting participants. Contact the research team at mark.clapp@mgh.harvard.edu for enrollment information.
Where is the NCT06557005 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06557005 clinical trial?
NCT06557005 is sponsored by Massachusetts General Hospital. The principal investigator is Mark A Clapp, MD, MPH at Massachusetts General Hospital. The trial plans to enroll 1,320 participants.