Bridging the Gap From Postpartum to Primary Care

NCT05543265 | Completed Results DMC

• 3 other identifiers: 2022P001723P30AG034532P30AG064190
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Postpartum Care; Primary Care; Care Transitions

Outcome Measures

Primary Outcomes (1)

• Rate of Primary Care Provider Visit Attendance

  Any visit with 1) a primary care provider (e.g., internal medicine, family medicine, pediatrics, gynecology) and 2) receipt of "annual" or "health care maintenance" services OR disease-specific management (diabetes, hypertension, obesity, mental health)

  4 months after the patient's estimated date of delivery

Secondary Outcomes (27)

• Rate of Primary Care Provider Visit Attendance

  12 months after the patient's estimated date of delivery

• 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)

  4 months after the patient's estimated date of delivery

• 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)

  12 months after the patient's estimated date of delivery

• Rate of Visit Unscheduled Health Care Visit/Encounter by the Time of Outcome Assessment

  4 months after the patient's estimated date of delivery

• Rate of Visit Unscheduled Health Care Visit/Encounter

  12 months after the patient's estimated date of delivery

Study Arms (2)

Control

NO INTERVENTION

Routine postpartum care

Facilitated Transition

EXPERIMENTAL

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

Behavioral: Default appointment scheduling; Behavioral: Targeted messaging; Behavioral: Nudge Reminders

Interventions

Default appointment scheduling BEHAVIORAL

Default primary care appointment scheduling

Facilitated Transition

Targeted messaging BEHAVIORAL

Patient-specific messages about the importance of postpartum care transition

Facilitated Transition

Nudge Reminders BEHAVIORAL

Primary care appointment reminders

Facilitated Transition

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute on Aging (NIA): collaborator
• National Bureau of Economic Research, Inc.: collaborator
• Massachusetts Institute of Technology: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (3)

• 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.

  PMID: 40117132 DERIVED

• 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.

  PMID: 39012630 DERIVED

• 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.

  PMID: 38633772 DERIVED

MeSH Terms

Conditions

Hypertension; Hypertension, Pregnancy-Induced; Diabetes Mellitus; Diabetes, Gestational; Obesity; Depressive Disorder; Anxiety Disorders

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Mark Clapp, MD
• Organization: Massachusetts General Hospital

mark.clapp@mgh.harvard.edu

617-724-2000

Study Officials

• Mark A Clapp, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Jessica L Cohen, PhD

  Harvard School of Public Health (HSPH)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician Investigator

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 16, 2022
• Study Start: November 3, 2022
• Primary Completion: October 11, 2023
• Study Completion: July 23, 2024
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)