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

NCT06557005 | Recruiting

• 2 other identifiers: 2024P002210R01HS030245-01
• Study Type: interventional
• Target: 1,320
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Postpartum Care; Primary Care; Care Transitions; Chronic Disease

Outcome Measures

Primary Outcomes (4)

• Completion of a primary care visit

  Observation of a visit with a primary care practitioner (defined as physicians and advanced practice clinicians affiliated with the following medical specialties: internal medicine, family medicine, pediatrics and adolescent medicine, and gynecology).

  155 days after date of delivery

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

  For individuals with gestational hypertensive disorders, appropriate management is defined as blood pressure screening by a primary care practitioner as documented in the electronic health record. For individuals with gestational diabetes, appropriate management is defined as observation of a postpartum glucose screening testing (e.g., GTT, HgbA1c) in the electronic health record. For individuals with chronic conditions, appropriate management is defined as receipt of both condition-specific screening (mood, weight, blood pressure and/or diabetes screening) and receipt of counseling, discussion of a management, and/or referral for or acknowledgment of subspecialist management for that condition by a primary care practitioner as documented in the electronic health record. "

  155 days after date of delivery

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

  The outcome is the Self-report of having a known, reliable primary care practitioner (doctor, nurse practitioner, or physician's assistant).

  155 days after date of delivery

• Self-report of mental health

  Edinburgh Perinatal Depression Scale will be administered and the total EPDS score compared.

  155 days after date of delivery

Secondary Outcomes (41)

• Completion of an annual exam with a primary care practitioner

  155 days after date of delivery

• Self-report of completion of a primary care visit

  155 days after date of delivery

• Self-report of an annual exam with a primary care practitioner

  155 days after date of delivery

• Completion of a primary care visit

  365 days after date of delivery

• Self-report of completion of a primary care visit

  365 days after date of delivery

Study Arms (2)

Routine Care

NO INTERVENTION

Routine postpartum care

Facilitated Transition Group

ACTIVE COMPARATOR

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.

Other: Facilitated Transition to Primary Care

Interventions

Facilitated Transition to Primary Care 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.

Facilitated Transition Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Harvard School of Public Health (HSPH): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus; Anxiety Disorders; Depression; Obesity; Chronic Disease

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Mental Disorders; Behavioral Symptoms; Behavior; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Mark A Clapp, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark A Clapp, MD, MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician Investigator

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 16, 2024
• Study Start: May 23, 2025
• Primary Completion (Estimated): May 23, 2027
• Study Completion (Estimated): May 23, 2028
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data and materials will be available after planned primary and secondary analyses are completed by the research team or at the end of the award, whichever occurs last (expected 08/2029). Data will be available and accessible for at least 5 years after posting.
• Access Criteria: Study metadata, code, and a deidentified data set that includes all collected trial data will be publicly available, without restricted access, on the Harvard Dataverse Repository

Locations

US (1)