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

Bridges to Primary Care: Transforming Postpartum Primary Care Coordination for People With Chronic Conditions

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.

Study Overview

• Status: Recruiting
• Conditions: Depression; Hypertension; Obesity; Diabetes; Pregnancy; Anxiety; Postpartum
• Intervention / Treatment: Other: Facilitated Transition to Primary Care

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.

• Study Type: Interventional
• Enrollment (Estimated): 1320
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mark A Clapp, MD, MPH; Phone Number: 617-726-2000; Email: mark.clapp@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Routine Care; Routine postpartum care
Active Comparator: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion of an annual exam with a primary care practitioner	Observation of an annual exam or health care maintenance 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
Self-report of completion of a primary care visit	Self-report 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) for any reason.	155 days after date of delivery
Self-report of an annual exam with a primary care practitioner	Self-report of an annual exam or health care maintenance 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
Completion of a primary care visit	Observation of a visit with a primary care practitioner for any reason.	365 days after date of delivery
Self-report of completion of a primary care visit	Self-report 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) for any reason.	365 days after date of delivery
Completion of an annual exam with a primary care practitioner	Observation of an annual exam or health care maintenance 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).	365 days after date of delivery
Self-report of an annual exam with a primary care practitioner	Self-report of an annual exam or health care maintenance 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).	365 days after date of delivery
Repeated primary care practitioner engagement	Observation of two or more primary care practitioner visits for any reason.	365 days after date of delivery
Self-report of repeated primary care practitioner engagement	Self-report of two or more primary care practitioner visits for any reason.	365 days after date of delivery
Extent of primary care practitioner engagement	Number of primary care practitioner visits for any reason.	365 days after date of delivery
Self-report of extent of primary care practitioner engagement	Self-report of the number of primary care practitioner visits for any reason.	365 days after date of delivery
Completion of a primary care visit	Observation of a visit with a primary care practitioner for any reason.	548 days after date of delivery
Completion of an annual exam with a primary care practitioner	Observation of an annual exam or health care maintenance visit with a primary care practitioner.	548 days after date of delivery
Repeated primary care practitioner engagement	Observation of two or more primary care practitioner visits for any reason.	548 days after date of delivery
Extent of primary care practitioner engagement	Number of primary care practitioner visits for any reason.	548 days after date of delivery
Self-report of 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 reported by the participant. For individuals with gestational diabetes, appropriate management is defined as observation of a postpartum glucose screening testing (e.g., GTT, HgbA1c) as reported by the participant. 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 reported by the participant.	155 days after date of delivery
Receipt of recommended screening and counseling for chronic condition by primary care practitioner	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
Receipt of recommended screening for gestational condition by 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."	155 days after date of delivery
Receipt of recommended screening and counseling for chronic condition by primary care practitioner	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.	365 days after date of delivery
Receipt of recommended screening for gestational condition by 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.	365 days after date of delivery
Receipt of recommended screening and counseling for chronic condition by primary care practitioner	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.	548 days after date of delivery
Receipt of recommended screening for gestational condition by 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.	548 days after date of delivery
Self-report of receipt of recommended screening and counseling for chronic condition by primary care practitioner	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 reported by the participant.	365 days after date of delivery
Self-report of receipt of recommended screening for gestational condition by primary care practitioner	For individuals with gestational hypertensive disorders, appropriate management is defined as blood pressure screening by a primary care practitioner as reported by the participant. For individuals with gestational diabetes, appropriate management is defined as observation of a postpartum glucose screening testing (e.g., GTT, HgbA1c) as reported by the participant. "	365 days after date of delivery
Self-report of having a known, reliable primary care practitioner	Participant report of having a known, reliable primary care practitioner (doctor, nurse practitioner, or physician's assistant).	365 days after date of delivery
Self-report of mental health	Edinburgh Perinatal Depression Scale score as reported by the participant.	365 days after date of delivery
Interpregnancy interval	Defined as the time (in days) from date of delivery until subsequent date of conception.	365 days after date of delivery
Interpregnancy interval	Defined as the time (in days) from date of delivery until subsequent date of conception.	584 days after date of delivery
Urgent or emergent care use	Emergency department or urgent care visit for any reason as documented in the electronic health record.	155 days after date of delivery
Self-report of urgent or emergent care use	Emergency department or urgent care visit for any reason as documented as reported by the participant.	155 days after date of delivery
Urgent or emergent care use	Emergency department or urgent care visit for any reason as documented in the electronic health record.	365 days after date of delivery
Self-report of urgent or emergent care use	Emergency department or urgent care visit for any reason as reported by the participant.	365 days after date of delivery
Urgent or emergent care use	Emergency department or urgent care visit for any reason as documented in the electronic health record.	584 days after date of delivery
Prescription or documentation of medication use for the treatment of a pre-existing or newly diagnosed mood or anxiety disorder	Observation of a prescription for or provider documentation noting the use of a medication for the treatment of a pre-existing or newly diagnosed mood or anxiety disorder in the electronic health record.	155 days
Prescription or documentation of medication use for the treatment of a pre-existing or newly diagnosed mood or anxiety disorder	Observation of a prescription for or provider documentation noting the use of a medication for the treatment of a pre-existing or newly diagnosed mood or anxiety disorder in the electronic health record.	365 days
Prescription or documentation of medication use for the treatment of a pre-existing or newly diagnosed mood or anxiety disorder	Observation of a prescription for or provider documentation noting the use of a medication for the treatment of a pre-existing or newly diagnosed mood or anxiety disorder in the electronic health record.	584 days
Contraception use	The use of any form of contraception as documented in the electronic health record	155 days
Contraception use	The use of any form of contraception as documented in the electronic health record	365 days
Contraception use	The use of any form of contraception as documented in the electronic health record	584 days
Self-report of contraception	Self-report of using contraception or discussing family planning/contraception	155 days
Self-report of contraception	Self-report of using contraception or discussing family planning/contraception	365 days

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Harvard School of Public Health (HSPH)
• Investigators: Principal Investigator: Mark A Clapp, MD, MPH, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2025
• Primary Completion (Estimated): May 23, 2027
• Study Completion (Estimated): May 23, 2028

Study Registration Dates

• First Submitted: August 13, 2024
• First Submitted That Met QC Criteria: August 13, 2024
• First Posted (Actual): August 16, 2024

Study Record Updates

• Last Update Posted (Actual): June 3, 2025
• Last Update Submitted That Met QC Criteria: May 27, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Primary Care; Chronic Disease; Postpartum Care; Care Transitions
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: 2024P002210; R01HS030245-01 (U.S. AHRQ Grant/Contract: Agency for Healthcare Quality and Research)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Data sets generated for this analysis will be preserved and shared publicly after planned primary and secondary analyses are completed by the research team or at the end of the award, whichever occurs last. Data will be preserved for at least 5 years after public posting to ensure outside investigators can access and use this information for related research.

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.

• IPD Sharing 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.
• IPD Sharing 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No