RecruitingNot Applicable

Facilitated Transitions From Postpartum to Primary Care Coordination for People With Chronic Conditions

United States1,320 participantsStarted 2025-05-23

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Given that I have one or more of the conditions this study focuses on — like hypertension, diabetes, anxiety, depression, or obesity — do you think participating in a program designed to connect postpartum patients to primary care could help me stay on top of managing those conditions after delivery?
2This trial is measuring whether people actually follow through with primary care visits and get condition-specific screenings after the postpartum period — how does that align with the gaps you've seen in my own care plan, and would this kind of support make a difference for me?
3Since this study is listed as 'Phase NA,' meaning it's evaluating a care coordination approach rather than a drug or device, can you help me understand what the actual program involves day-to-day, and what would be expected of me as a participant?
4The study tracks self-reported mental health as one of its main outcomes — given that I may be dealing with postpartum anxiety or depression alongside a physical condition, do you think having a structured path to primary care could realistically support both my physical and mental health needs?
5If I don't join this trial, what's your plan for making sure I have a reliable primary care provider and get the recommended screenings for my specific conditions during the postpartum period?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Completion of a primary care visit

Timeframe: 155 days after date of delivery

Receipt of condition-specific recommended health screening and counseling by a primary care practitioner

Timeframe: 155 days after date of delivery

Self-report of having a known, reliable primary care practitioner

Timeframe: 155 days after date of delivery

Self-report of mental health

Timeframe: 155 days after date of delivery

Trial details

NCT IDNCT06557005

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05-23

Contact for this trial

Mark A Clapp, MD, MPH

617-726-2000 mark.clapp@mgh.harvard.edu

View on ClinicalTrials.gov More Hypertension trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Completion of a primary care visit

Timeframe: 155 days after date of delivery

Receipt of condition-specific recommended health screening and counseling by a primary care practitioner