Facilitated Transitions From Postpartum to Primary Care Coordination for People With Chronic Conditions
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Chronic or essential hypertension
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Facilitated Transition to Primary Care
Other interventionThe 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.
Treatment groups
1,320 Participants
are divided into 2 treatment groupsGroup A: Routine CareNo intervention 0 interventions
Group B: Facilitated Transition GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
155 days after date of delivery2
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. "
Time frame
155 days after date of delivery3
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).
Time frame
155 days after date of delivery4
Self-report of mental health
Edinburgh Perinatal Depression Scale will be administered and the total EPDS score compared.
Time frame
155 days after date of deliverySecondary outcomes
1
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).
Time frame
155 days after date of delivery2
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.
Time frame
155 days after date of delivery3
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).
Time frame
155 days after date of delivery4
Completion of a primary care visit
Observation of a visit with a primary care practitioner for any reason.
Time frame
365 days after date of deliverySponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
Harvard School of Public Health (HSPH)
Collaborator
Source ClinicalTrials.gov