Clinical trial NCT06557005: Facilitated Transitions From Postpartum to Primary Care Coordination for People With Chronic Conditions
Official title: Bridges to Primary Care: Transforming Postpartum Primary Care Coordination for People With Chronic Conditions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Diabetes
Postpartum
Pregnancy
Anxiety
Depression
Obesity
Keywords: Postpartum Care
Primary Care
Care Transitions
Chronic Disease
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Harvard School of Public Health (HSPH)
First posted: 2024-08-16
Enrollment: 1320
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Exclusion Criteria

• Any individual not meeting all inclusion criteria

Primary outcomes:
measure: Completion of a primary care visit
timeFrame: 155 days after date of delivery
measure: Receipt of condition-specific recommended health screening and counseling by a primary care practitioner
timeFrame: 155 days after date of delivery
measure: Self-report of having a known, reliable primary care practitioner
timeFrame: 155 days after date of delivery
measure: Self-report of mental health
timeFrame: 155 days after date of delivery
Secondary outcomes:
measure: Completion of an annual exam with a primary care practitioner
timeFrame: 155 days after date of delivery
measure: Self-report of completion of a primary care visit
timeFrame: 155 days after date of delivery
measure: Self-report of an annual exam with a primary care practitioner
timeFrame: 155 days after date of delivery
measure: Completion of a primary care visit
timeFrame: 365 days after date of delivery
measure: Self-report of completion of a primary care visit
timeFrame: 365 days after date of delivery
measure: Completion of an annual exam with a primary care practitioner
timeFrame: 365 days after date of delivery
measure: Self-report of an annual exam with a primary care practitioner
timeFrame: 365 days after date of delivery
measure: Repeated primary care practitioner engagement
timeFrame: 365 days after date of delivery
measure: Self-report of repeated primary care practitioner engagement
timeFrame: 365 days after date of delivery
measure: Extent of primary care practitioner engagement
timeFrame: 365 days after date of delivery
measure: Self-report of extent of primary care practitioner engagement
timeFrame: 365 days after date of delivery
measure: Completion of a primary care visit
timeFrame: 548 days after date of delivery
measure: Completion of an annual exam with a primary care practitioner
timeFrame: 548 days after date of delivery
measure: Repeated primary care practitioner engagement
timeFrame: 548 days after date of delivery
measure: Extent of primary care practitioner engagement
timeFrame: 548 days after date of delivery
measure: Self-report of receipt of condition-specific recommended health screening and counseling by a primary care practitioner
timeFrame: 155 days after date of delivery
measure: Receipt of recommended screening and counseling for chronic condition by primary care practitioner
timeFrame: 155 days after date of delivery
measure: Receipt of recommended screening for gestational condition by primary care practitioner
timeFrame: 155 days after date of delivery
measure: Receipt of recommended screening and counseling for chronic condition by primary care practitioner
timeFrame: 365 days after date of delivery
measure: Receipt of recommended screening for gestational condition by primary care practitioner
timeFrame: 365 days after date of delivery
measure: Receipt of recommended screening and counseling for chronic condition by primary care practitioner
timeFrame: 548 days after date of delivery
measure: Receipt of recommended screening for gestational condition by primary care practitioner
timeFrame: 548 days after date of delivery
measure: Self-report of receipt of recommended screening and counseling for chronic condition by primary care practitioner
timeFrame: 365 days after date of delivery
measure: Self-report of receipt of recommended screening for gestational condition by primary care practitioner
timeFrame: 365 days after date of delivery
measure: Self-report of having a known, reliable primary care practitioner
timeFrame: 365 days after date of delivery
measure: Urgent or emergent care use
timeFrame: 155 days after date of delivery
measure: Self-report of urgent or emergent care use
timeFrame: 155 days after date of delivery
measure: Urgent or emergent care use
timeFrame: 365 days after date of delivery
measure: Self-report of urgent or emergent care use
timeFrame: 365 days after date of delivery
measure: Self-report of mental health
timeFrame: 365 days after date of delivery
measure: Urgent or emergent care use
timeFrame: 584 days after date of delivery
measure: Interpregnancy interval
timeFrame: 365 days after date of delivery
measure: Interpregnancy interval
timeFrame: 584 days after date of delivery
measure: Prescription or documentation of medication use for the treatment of a pre-existing or newly diagnosed mood or anxiety disorder
timeFrame: 155 days
measure: Prescription or documentation of medication use for the treatment of a pre-existing or newly diagnosed mood or anxiety disorder
timeFrame: 365 days
measure: Prescription or documentation of medication use for the treatment of a pre-existing or newly diagnosed mood or anxiety disorder
timeFrame: 584 days
measure: Contraception use
timeFrame: 155 days
measure: Contraception use
timeFrame: 365 days
measure: Contraception use
timeFrame: 584 days
measure: Self-report of contraception
timeFrame: 155 days
measure: Self-report of contraception
timeFrame: 365 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Mark A Clapp, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: