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

NCT ID: NCT06557005

Last Updated: 2025-06-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-23
• Study Completion Date: 2028-05-23

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.

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 chronic disease later in life. While patients with these conditions are typically highly engaged in prenatal care, they encounter a "postpartum cliff" in health system support after delivery; many receive no postpartum primary care at all despite having ongoing medical needs. At a time of increased stress, sleep deprivation, and competing demands, they must navigate administrative burdens in accessing primary care, often without scheduling assistance or any formal handoff between their obstetric and primary care clinician (PCP). These burdens may lead to avoided or delayed postpartum primary care, exacerbating health inequities that existed prenatally even for those fortunate enough to have a PCP. Given the many benefits of primary care, this lack of obstetric-to-primary care coordination represents a missed opportunity to increase primary care engagement and manage chronic conditions earlier in life. The primary objective is to increase postpartum primary care engagement, quality, and experience by strengthening obstetric-to-primary care coordination using a behavioral economics-informed intervention. The intervention, integrated into routine inpatient postpartum care, includes default PCP visit scheduling, tailored nudge messages to patients, ongoing care recommendations sent to the PCP, and a summary of recommendations after pregnancy given to the patient. Using a robust randomized controlled trial of 1,320 participants that is built off of the team's pilot study, the proposed study will: (Aim 1) measure the intervention's impact on postpartum primary care visit completion, sustained engagement, and disparities in these outcomes; (Aim 2) measure the intervention's impact on high-value primary care service use; and (Aim 3) measure the intervention's impact on patient experience. The study will generate rigorous, actionable evidence to ensure primary care coordination becomes standard postpartum care practice and will provide insight into postpartum patients' health care experiences. By targeting a vulnerable population at a time of great need and opportunity, postpartum-to-primary care coordination has the potential to catalyze sustained primary care engagement throughout life and improve long-term health.

Conditions

Hypertension; Diabetes; Postpartum; Pregnancy; Anxiety; Depression; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Routine Care

Routine postpartum care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Facilitated Transition Group

The intervention is integrated into routine inpatient postpartum care and includes the following components: default PCP visit scheduling, tailored nudge messages to patients, ongoing care recommendations sent to the PCP, and a summary of recommendations after pregnancy given to the patient.

Group Type: ACTIVE_COMPARATOR

Facilitated Transition to Primary Care

Intervention Type: OTHER

The intervention includes default PCP visit scheduling, tailored nudge messages to patients, ongoing care recommendations sent to the PCP, and a summary of recommendations after pregnancy given to the patient.

Interventions

Facilitated Transition to Primary Care

The intervention includes default PCP visit scheduling, tailored nudge messages to patients, ongoing care recommendations sent to the PCP, and a summary of recommendations after pregnancy given to the patient.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mark Clapp, MD MPH

Physician Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark A Clapp, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mark A Clapp, MD, MPH

Role: CONTACT

mark.clapp@mgh.harvard.edu

617-726-2000

Other Identifiers

R01HS030245-01

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

2024P002210

Identifier Type: -

Identifier Source: org_study_id