Bridging the Gap From Postpartum to Primary Care

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05543265
Collaborator
National Institute on Aging (NIA) (NIH), National Bureau of Economic Research, Inc. (Other), Massachusetts Institute of Technology (Other)
350
1
2
11
31.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Default appointment scheduling
  • Behavioral: Targeted messaging
  • Behavioral: Nudge Reminders
N/A

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
350 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
Bridging the Gap From Postpartum to Primary Care: A Behavioral Science Informed Intervention to Improve Chronic Disease Management Among Postpartum Women
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control

Routine postpartum care

Experimental: Facilitated Transition

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

Behavioral: Default appointment scheduling
Default primary care appointment scheduling

Behavioral: Targeted messaging
Patient-specific messages about the importance of postpartum care transition

Behavioral: Nudge Reminders
Primary care appointment reminders

Outcome Measures

Primary Outcome Measures

  1. Rate of primary care provider visit attendance [4 months after the patient's estimated date of delivery]

    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)

Secondary Outcome Measures

  1. Rate of primary care provider visit attendance [12 months after the patient's estimated date of delivery]

    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)

  2. 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]

    Health care maintenance visit appointment with the patient's assigned primary care provider

  3. 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]

    Health care maintenance visit appointment with the patient's assigned primary care provider

  4. Rate of visit unscheduled health care visit/encounter by the time of outcome assessment [4 months after the patient's estimated date of delivery]

    Any visit to a urgent care or emergency room visit

  5. Rate of visit unscheduled health care visit/encounter [12 months after the patient's estimated date of delivery]

    Any visit to a urgent care or emergency room visit

  6. Rate of contraception plan documented by the time of outcome assessment [4 months after the patient's estimated date of delivery]

    Contraception plan documented by any provider after delivery

  7. Rate of long-acting contraception use at time of outcome assessment [4 months after the patient's estimated date of delivery]

    Long-acting contraception use (implant, intrauterine device)

  8. Rate of long-acting contraception use [12 months after the patient's estimated date of delivery]

    Long-acting contraception use (implant, intrauterine device)

  9. Rate of contraception plan documented [12 months after the patient's estimated date of delivery]

    Contraception plan documented by any provider after delivery

  10. Rate of pregestational diabetes screening among individuals with gestational diabetes [4 months after the patient's estimated date of delivery]

    Postpartum diabetes screening among those diagnosed with gestational diabetes

  11. Rate of pregestational diabetes screening among individuals with gestational diabetes [12 months after the patient's estimated date of delivery]

    Postpartum diabetes screening among those diagnosed with gestational diabetes

  12. Rate of weight counseling documented in the health record among those with obesity [4 months after the patient's estimated date of delivery]

    Weight counseling documentation among those with obesity

  13. Rate of weight counseling documented in the health record among those with obesity [12 months after the patient's estimated date of delivery]

    Weight counseling documentation among those with obesity

  14. Rate of blood pressure measurement documented in the health record among those with or at risk for hypertension [4 months after the patient's estimated date of delivery]

    Blood pressure documented in the EHR among those diagnosed within chronic or pregnancy-related hypertension

  15. Rate of blood pressure measurement documented in the health record among those with or at risk for hypertension [12 months after the patient's estimated date of delivery]

    Blood pressure documented in the EHR among those diagnosed within chronic or pregnancy-related hypertension

  16. Rate of mental health service referral or use among individuals with mood or anxiety disorders [4 months after the patient's estimated date of delivery]

    Clinical support services (e.g., social work, psychiatry, therapy) for individuals with mood or anxiety disorders

  17. Rate of mental health service referral or use among individuals with mood or anxiety disorders [12 months after the patient's estimated date of delivery]

    Clinical support services (e.g., social work, psychiatry, therapy) for individuals with mood or anxiety disorders

  18. Rate of antidepressant use among individuals with mood or anxiety disorders [4 months after the patient's estimated date of delivery]

    New or continued antidepressant prescription use

  19. Rate of antidepressant use among individuals with mood or anxiety disorders [12 months after the patient's estimated date of delivery]

    New or continued antidepressant prescription use

  20. Rate of antihypertensive use among individuals with hypertension [4 months after the patient's estimated date of delivery]

    New or continued antihypertensive medication use among individuals with hypertension

  21. Rate of antihypertensive use among individuals with hypertension [12 months after the patient's estimated date of delivery]

    New or continued antihypertensive medication use among individuals with hypertension

  22. Rate of medication use for glycemic control among individuals with diabetes [4 months after the patient's estimated date of delivery]

    New or continued oral or subcutaneous diabetes medication use control among individuals with diabetes

  23. Rate of medication use for glycemic control among individuals with diabetes [12 months after the patient's estimated date of delivery]

    New or continued oral or subcutaneous diabetes medication use control among individuals with diabetes

  24. Rate of assessment of glycemic control among individuals with or at risk for diabetes [4 months after the patient's estimated date of delivery]

    Laboratory glucose screening test among individuals with or at risk for diabetes

  25. Rate of assessment of glycemic control among individuals with or at risk for diabetes [12 months after the patient's estimated date of delivery]

    Laboratory glucose screening test among individuals with or at risk for diabetes

  26. Rate of patient-reported primary care visit attendance [4 months after the patient's estimated date of delivery]

    Primary care provider visit attendance per patient report

  27. Rate of patient-reported primary care visit attendance [12 months after the patient's estimated date of delivery]

    Primary care provider visit attendance per patient report

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Exclusion Criteria:
  • No primary care provider listed in the EHR

  • Primary language other than English or Spanish

  • No access to online patient EHR portal

Contacts and Locations

Locations

Site City State Country Postal Code
1 Massachusetts General Hospital Boston Massachusetts United States 02115

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Mark A Clapp, MD, MPH, Massachusetts General Hospital
  • Principal Investigator: Jessica L Cohen, PhD, Harvard School of Public Health (HSPH)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mark Clapp, MD MPH, Physician Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT05543265
Other Study ID Numbers:
  • 2022P001723
  • P30AG034532
  • P30AG064190
First Posted:
Sep 16, 2022
Last Update Posted:
Sep 16, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mark Clapp, MD MPH, Physician Investigator, Massachusetts General Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 16, 2022