Clinical trial NCT05543265: Bridging the Gap From Postpartum to Primary Care
Official title: Bridging the Gap From Postpartum to Primary Care: A Behavioral Science Informed Intervention to Improve Chronic Disease Management Among Postpartum Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Hypertension in Pregnancy
Diabetes Mellitus
Gestational Diabetes
Obesity
Depressive Disorder
Anxiety Disorders
Keywords: Postpartum Care
Primary Care
Care Transitions
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: National Bureau of Economic Research, Inc.
name: Massachusetts Institute of Technology
First posted: 2022-09-16
Enrollment: 360
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: Chronic health conditions affect most older adults. Preventative medicine and risk management strategies, especially when applied earlier in life, are essential to altering the trajectory of a disease and ultimately improving health outcomes. Primary care providers (PCP) often provide most of these services, though younger adults are the least likely to receive primary care. This project leverages a period of high engagement and health activation during an individual's life (pregnancy) to nudge her toward use of primary care after the pregnancy episode. This randomized controlled trial will test the hypothesis that a behavioral science-informed intervention, incorporating defaults and salience, can increase the rates of PCP follow-up within 4 months following a delivery for individual with hypertension, diabetes, obesity. If successful, this intervention could serve as a scalable solution to increase primary care use and preventative health services in a population that currently has low rates of engagement and utilization of these services.

Detailed description: Individuals will be randomized with equal probability into either a treatment or control arm. The intervention combines several features designed to target reasons for low take-up of primary care among postpartum individuals. This project will leverage the potential value of defaults/opt-out, salient information, and reminders to encourage use of primary care. Individuals in both the intervention and control arms will receive information via the study institution's patient portal toward the end of the pregnancy regarding the importance and benefits of primary care in the postpartum year. This information will be similar to, but reinforcing, the information they would receive from their obstetrician about following up with their primary care physician. In addition to this initial message, individuals in the treatment arm will receive the following intervention components, developed based on recent evidence regarding behavioral science approaches to activating health behaviors:

1. Targeted messages about the importance and benefits of primary care
2. Default scheduling into a primary care appointment at approximately 3-4 months after delivery
3. Reminders about the appointment and importance of follow up primary care at 2-4 points during the postpartum period via the patient portal
4. Tailored language in the reminders based on recent evidence from behavioral science about the most effective approaches to increasing take-up. For example, messages will inform the patient that an appointment is being held for them at their doctor.
5. Salient labeling on follow-up appointments
6. Direct PCP messaging about the scheduled follow-up

Eligibility criteria: Inclusion Criteria:

* Estimated date of delivery and the following 4-month postpartum outcome assessment window completed prior to study end date
* Currently pregnant or within 2 weeks of delivery
* Have one or more of the following conditions: 1) Chronic hypertension, 2) Hypertensive disorders of pregnancy or risk factors for hypertensive disorders of pregnancy per the USPSTF aspirin prescribing guidelines (e.g., history of pre-eclampsia, kidney disease, multiple gestation, autoimmune disease), 3) Type 1 or 2 diabetes, 4) Gestational diabetes, 5) Obesity (pre-pregnancy body mass index ≥30 kg/m2), 6) Depression or anxiety disorder
* Have a primary care provider listed in the electronic health record (EHR)
* Receive obstetric care at the study institution's outpatient prenatal clinic
* Have access to and be enrolled in the EHR patient portal and consents to be contacted via these modalities
* Able to read/speak English or Spanish language
* Age ≥18 years old
* Not actively known to have or undergoing work-up for fetal demise

Exclusion Criteria:

* No primary care provider listed in the EHR
* Primary language other than English or Spanish
* No access to online patient EHR portal

Primary outcomes:
measure: Rate of Primary Care Provider Visit Attendance
timeFrame: 4 months after the patient's estimated date of delivery
Secondary outcomes:
measure: Rate of Primary Care Provider Visit Attendance
timeFrame: 12 months after the patient's estimated date of delivery
measure: Rate of Visit With a Patient's Assigned Primary Care Provider for Receipt of "Annual" or "Health Care Maintenance" Services OR Disease-specific Management (Diabetes, Hypertension, Obesity, Mental Health)
timeFrame: 4 months after the patient's estimated date of delivery
measure: Rate of Visit With a Patient's Assigned Primary Care Provider for Receipt of "Annual" or "Health Care Maintenance" Services OR Disease-specific Management (Diabetes, Hypertension, Obesity, Mental Health)
timeFrame: 12 months after the patient's estimated date of delivery
measure: Rate of Visit Unscheduled Health Care Visit/Encounter by the Time of Outcome Assessment
timeFrame: 4 months after the patient's estimated date of delivery
measure: Rate of Visit Unscheduled Health Care Visit/Encounter
timeFrame: 12 months after the patient's estimated date of delivery
measure: Rate of Contraception Plan Documented by the Time of Outcome Assessment
timeFrame: 4 months after the patient's estimated date of delivery
measure: Rate of Long-acting Contraception Use at Time of Outcome Assessment
timeFrame: 4 months after the patient's estimated date of delivery
measure: Rate of Long-acting Contraception Use
timeFrame: 12 months after the patient's estimated date of delivery
measure: Rate of Contraception Plan Documented
timeFrame: 12 months after the patient's estimated date of delivery
measure: Rate of Pregestational Diabetes Screening Among Individuals With Gestational Diabetes
timeFrame: 4 months after the patient's estimated date of delivery
measure: Rate of Pregestational Diabetes Screening Among Individuals With Gestational Diabetes
timeFrame: 12 months after the patient's estimated date of delivery
measure: Rate of Weight Counseling Documented in the Health Record Among Those With Obesity
timeFrame: 4 months after the patient's estimated date of delivery
measure: Rate of Weight Counseling Documented in the Health Record Among Those With Obesity
timeFrame: 12 months after the patient's estimated date of delivery
measure: Rate of Blood Pressure Measurement Documented in the Health Record Among Those With or at Risk for Hypertension
timeFrame: 4 months after the patient's estimated date of delivery
measure: Rate of Blood Pressure Measurement Documented in the Health Record Among Those With or at Risk for Hypertension
timeFrame: 12 months after the patient's estimated date of delivery
measure: Rate of Mental Health Service Referral or Use Among Individuals With Mood or Anxiety Disorders
timeFrame: 4 months after the patient's estimated date of delivery
measure: Rate of Mental Health Service Referral or Use Among Individuals With Mood or Anxiety Disorders
timeFrame: 12 months after the patient's estimated date of delivery
measure: Rate of Antidepressant Use Among Individuals With Mood or Anxiety Disorders
timeFrame: 4 months after the patient's estimated date of delivery
measure: Rate of Antidepressant Use Among Individuals With Mood or Anxiety Disorders
timeFrame: 12 months after the patient's estimated date of delivery
measure: Rate of Antihypertensive Use Among Individuals With Hypertension
timeFrame: 4 months after the patient's estimated date of delivery
measure: Rate of Antihypertensive Use Among Individuals With Hypertension
timeFrame: 12 months after the patient's estimated date of delivery
measure: Rate of Medication Use for Glycemic Control Among Individuals With Diabetes
timeFrame: 4 months after the patient's estimated date of delivery
measure: Rate of Medication Use for Glycemic Control Among Individuals With Diabetes
timeFrame: 12 months after the patient's estimated date of delivery
measure: Rate of Assessment of Glycemic Control Among Individuals With or at Risk for Diabetes
timeFrame: 4 months after the patient's estimated date of delivery
measure: Rate of Assessment of Glycemic Control Among Individuals With or at Risk for Diabetes
timeFrame: 12 months after the patient's estimated date of delivery
measure: Rate of Patient-reported Primary Care Visit Attendance
timeFrame: 4 months after the patient's estimated date of delivery
measure: Rate of Patient-reported Primary Care Visit Attendance
timeFrame: 12 months after the patient's estimated date of delivery
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
affiliation: Harvard School of Public Health (HSPH)
name: Jessica L Cohen, PhD
role: PRINCIPAL_INVESTIGATOR
References: