Bridging the Gap From Postpartum to Primary Care

NCT ID: NCT05543265

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-03
• Study Completion Date: 2024-07-23

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

Conditions

Hypertension; Hypertension in Pregnancy; Diabetes Mellitus; Gestational Diabetes; Obesity; Depressive Disorder; Anxiety Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Control

Routine postpartum care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Facilitated Transition

Behavioral science informed interventions to assist in the transition from postpartum to primary care providers

Group Type: EXPERIMENTAL

Default appointment scheduling

Intervention Type: BEHAVIORAL

Default primary care appointment scheduling

Targeted messaging

Intervention Type: BEHAVIORAL

Patient-specific messages about the importance of postpartum care transition

Nudge Reminders

Intervention Type: BEHAVIORAL

Primary care appointment reminders

Interventions

Default appointment scheduling

Default primary care appointment scheduling

Intervention Type: BEHAVIORAL

Targeted messaging

Patient-specific messages about the importance of postpartum care transition

Intervention Type: BEHAVIORAL

Nudge Reminders

Primary care appointment reminders

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

National Bureau of Economic Research, Inc.

OTHER

Sponsor Role: collaborator

Massachusetts Institute of Technology

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mark Clapp, MD MPH

Physician Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark A Clapp, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Jessica L Cohen, PhD

Role: PRINCIPAL_INVESTIGATOR

Harvard School of Public Health (HSPH)

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

Delgado A, Liang P, Bender T, Ray A, James KE, Ganguli I, Cohen JL, Clapp MA. Primary Care Utilization Within 1 Year After a Facilitated Postpartum-to-Primary Care Transition. Obstet Gynecol. 2025 Apr 1;145(4):409-416. doi: 10.1097/AOG.0000000000005848. Epub 2025 Feb 13.

Reference Type: DERIVED

PMID: 40117132 (View on PubMed)

Clapp MA, Ray A, Liang P, James KE, Ganguli I, Cohen JL. Postpartum Primary Care Engagement Using Default Scheduling and Tailored Messaging: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2422500. doi: 10.1001/jamanetworkopen.2024.22500.

Reference Type: DERIVED

PMID: 39012630 (View on PubMed)

Clapp MA, Ray A, Liang P, James KE, Ganguli I, Cohen J. Increasing Postpartum Primary Care Engagement through Default Scheduling and Tailored Messaging: A Randomized Clinical Trial. medRxiv [Preprint]. 2024 May 1:2024.01.21.24301585. doi: 10.1101/2024.01.21.24301585.

Reference Type: DERIVED

PMID: 38633772 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

P30AG034532

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P30AG064190

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2022P001723

Identifier Type: -

Identifier Source: org_study_id