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

Last registered on November 25, 2025

Pre-Trial

Trial Information

General Information

Title
Facilitated Transitions From Postpartum to Primary Care Coordination for People With Chronic Conditions
RCT ID
AEARCTR-0017295
Initial registration date
November 22, 2025

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
November 25, 2025, 8:07 AM EST

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

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Primary Investigator

Affiliation
Harvard School of Public Health

Other Primary Investigator(s)

PI Affiliation
Massachusetts General Hospital

Additional Trial Information

Status
On going
Start date
2025-05-23
End date
2028-05-23
Secondary IDs
NCT06557005
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
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.
External Link(s)

Registration Citation

Citation
Clapp, Mark and Jessica Cohen. 2025. "Facilitated Transitions From Postpartum to Primary Care Coordination for People With Chronic Conditions." AEA RCT Registry. November 25. https://doi.org/10.1257/rct.17295-1.0
Sponsors & Partners

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Experimental Details

Interventions

Intervention(s)
The primary objective of this intervention 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.
Intervention Start Date
2025-05-23
Intervention End Date
2028-05-23

Primary Outcomes

Primary Outcomes (end points)
1. Completion of a postpartum primary care visit
2. Receipt of condition-specific recommended health screening and counseling by a primary care practitioner
3. Self-report of having a known, reliable primary care practitioner
4. Self-report of mental health
Primary Outcomes (explanation)
1. Completion of a postpartum 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). Within 155 days after delivery.

2. 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. Within 155 days after delivery.
3. 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). Within 155 days after delivery.
4. Self-report of mental health
Edinburgh Perinatal Depression Scale will be administered and the total EPDS score compared. Within 155 days after delivery.

Secondary Outcomes

Secondary Outcomes (end points)
1. Completion of an annual exam with a primary care practitioner (155 days after date of delivery)
2. Self-report of completion of a primary care visit (155 days after date of delivery)
3. Self-report of an annual exam with a primary care practitioner (155 days after date of delivery)
4. Completion of a primary care visit (365 days after date of delivery)
5. Self-report of completion of a primary care visit (365 days after date of delivery)
6. Completion of an annual exam with a primary care practitioner (365 days after date of delivery)
7. Self-report of an annual exam with a primary care practitioner (365 days after date of delivery)
8. Repeated primary care practitioner engagement (365 days after date of delivery)
9. Self-report of repeated primary care practitioner engagement (365 days after date of delivery)
10. Extent of primary care practitioner engagement (365 days after date of delivery)
11. Self-report of extent of primary care practitioner engagement (365 days after date of delivery)
12. Completion of a primary care visit (548 days after date of delivery)
13. Completion of an annual exam with a primary care practitioner (548 days after date of delivery)
14. Repeated primary care practitioner engagement (548 days after date of delivery)
15. Extent of primary care practitioner engagement (548 days after date of delivery)
16. Self-report of receipt of condition-specific recommended health screening and counseling by a primary care practitioner (155 days after date of delivery)
17. Receipt of recommended screening and counseling for chronic condition by primary care practitioner (Within 155 days after delivery)
18. Receipt of recommended screening for gestational condition by primary care practitioner (Within 155 days after delivery)
19. Receipt of recommended screening and counseling for chronic condition by primary care practitioner (Within 155 days after delivery)
20. Receipt of recommended screening for gestational condition by primary care practitioner (Within 365 days after delivery)
21. Receipt of recommended screening and counseling for chronic condition by primary care practitioner (Within 365 days after delivery)
22. Receipt of recommended screening for gestational condition by primary care practitioner (Within 365 days after delivery)
23. Self-report of receipt of recommended screening and counseling for chronic condition by primary care practitioner (Within 365 days after delivery)
24. Self-report of receipt of recommended screening for gestational condition by primary care practitioner (Within 365 days after delivery)
25. Self-report of having a known, reliable primary care practitioner (365 days after date of delivery)
26. Urgent or emergent care use (155 days after date of delivery)
27. Self-report of urgent or emergent care use (155 days after date of delivery)
28. Urgent or emergent care use (365 days after date of delivery)
29. Self-report of urgent or emergent care use (365 days after date of delivery)
30. Self-report of mental health (365 days after date of delivery)
31. Urgent or emergent care use (365 days after date of delivery)
32. Interpregnancy interval (365 days after date of delivery)
33. Interpregnancy interval (584 days after date of delivery)
34. Prescription or documentation of medication use for the treatment of a pre-existing or newly diagnosed mood or anxiety disorder (155 days after delivery)
35. Prescription or documentation of medication use for the treatment of a pre-existing or newly diagnosed mood or anxiety disorder (365 days after date of delivery)
36. Prescription or documentation of medication use for the treatment of a pre-existing or newly diagnosed mood or anxiety disorder (584 days after date of delivery)
37. Contraception use (155 days after date of delivery)
38. Contraception use (365 days after date of delivery)
39. Contraception use (584 days after date of delivery)
40. Self-report of contraception (155 days after date of delivery)
41. Self-report of contraception (365 days after date of delivery)

Secondary Outcomes (explanation)

Experimental Design

Experimental Design
Control Group: Routine postpartum care
Intervention Group: Routine postpartum care plus 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.

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
Experimental Design Details
Not available
Randomization Method
Randomization will occur via a prespecified random allocation sequence within strata. Strata will be based on two variables: 1) site of prenatal care and 2) PCP affiliation with the study site health system. Within each stratum, the statistician will generate a random sequence of treatment-control allocation prior to the enrollment of subjects and upload the sequence into REDCap. Then, as subjects within strata are enrolled, they will be assigned to the treatment arm associated with that enrollment number using the REDCap randomization module.
Randomization Unit
The units of randomization are individuals
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
1,320 individuals
Sample size: planned number of observations
1,320 individuals
Sample size (or number of clusters) by treatment arms
660 individuals in control arm
660 individuals in treatment arm
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB

Institutional Review Boards (IRBs)

IRB Name
Mass General Brigham Institutional Review Board
IRB Approval Date
2024-09-16
IRB Approval Number
2024P002210