Bridging the Gap From Postpartum to Primary Care: A Behavioral Science Informed Intervention to Improve Chronic Disease Management Among Postpartum Women

Last registered on September 06, 2023

Pre-Trial

Trial Information

General Information

Title
Bridging the Gap From Postpartum to Primary Care: A Behavioral Science Informed Intervention to Improve Chronic Disease Management Among Postpartum Women
RCT ID
AEARCTR-0010071
Initial registration date
September 15, 2022

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
September 19, 2022, 4:19 PM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Last updated
September 06, 2023, 9:30 PM EDT

Last updated is the most recent time when changes to the trial's registration were published.

Locations

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Primary Investigator

Affiliation
Harvard School of Public Health

Other Primary Investigator(s)

PI Affiliation
Massachusetts General Hospital and Harvard Medical School

Additional Trial Information

Status
In development
Start date
2022-10-03
End date
2024-06-30
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
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 rates of follow-up with a PCP after a delivery for individuals with hypertension, diabetes, obesity and mental illness. 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.
External Link(s)

Registration Citation

Citation
Clapp, Mark and Jessica Cohen. 2023. "Bridging the Gap From Postpartum to Primary Care: A Behavioral Science Informed Intervention to Improve Chronic Disease Management Among Postpartum Women." AEA RCT Registry. September 06. https://doi.org/10.1257/rct.10071-2.0
Sponsors & Partners

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Experimental Details

Interventions

Intervention(s)
Individuals receiving prenatal or early postpartum care and who meet eligibility criteria 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 4 months after delivery
3. Reminders about the appointment and importance of follow up primary care 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.
5. Salient labeling on follow-up appointments
6. Direct PCP messaging about the scheduled follow-up
Intervention Start Date
2022-10-03
Intervention End Date
2023-05-31

Primary Outcomes

Primary Outcomes (end points)
Rate of primary care provider visit attendance
Defined as:
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)
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)

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)
[Time Frame: 12 months after expected delivery date]
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)
Health care maintenance visit appointment with the patient's assigned primary care provider [Time Frame: 4 months after expected delivery date]]

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)
Health care maintenance visit appointment with the patient's assigned primary care provider [Time Frame: 12 months after expected delivery date]
4. Rate of visit unscheduled health care visit/encounter by the time of outcome assessment
Any visit to urgent care or emergency room visit
[Time Frame: 4 months after expected delivery date]
5. Rate of visit unscheduled health care visit/encounter
Any visit to urgent care or emergency room visit
[Time Frame: 12 months after expected delivery date]
6. Rate of contraception plan documented by the time of outcome assessment
Contraception plan documented by any provider after delivery [Time Frame: 4 months after expected delivery date]
7. Rate of long-acting contraception use at time of outcome assessment
Long-acting contraception use (implant, intrauterine device) [Time Frame: 4 months after expected delivery date]
8. Rate of long-acting contraception use
Long-acting contraception use (implant, intrauterine device) [Time Frame: 12 months after expected delivery date]
9. Rate of contraception plan documented
Contraception plan documented by any provider after delivery [Time Frame: 12 months after expected delivery date]
10. Rate of pregestational diabetes screening among individuals with gestational diabetes
Postpartum diabetes screening among those diagnosed with gestational diabetes [Time Frame: 4 months after expected delivery date]
11. Rate of pregestational diabetes screening among individuals with gestational diabetes
Postpartum diabetes screening among those diagnosed with gestational diabetes [Time Frame: 12 months after expected delivery date]
12. Rate of weight counseling documented in the health record among those with obesity
Weight counseling documentation among those with obesity [Time Frame: 4 months after expected delivery date]
13. Rate of weight counseling documented in the health record among those with obesity
Weight counseling documentation among those with obesity [Time Frame: 12 months after expected delivery date]
14. Rate of blood pressure measurement documented in the health record among those with or at risk for hypertension
Blood pressure documented in the EHR among those diagnosed within chronic or pregnancy-related hypertension [Time Frame: 4 months after expected delivery date]
15. Rate of blood pressure measurement documented in the health record among those with or at risk for hypertension
Blood pressure documented in the EHR among those diagnosed within chronic or pregnancy-related hypertension [Time Frame: 12 months after expected delivery date]
16. Rate of mental health service referral or use among individuals with mood or anxiety disorders
Clinical support services (e.g., social work, psychiatry, therapy) for individuals with mood or anxiety disorders [Time Frame: 4 months after expected delivery date]
17. Rate of mental health service referral or use among individuals with mood or anxiety disorders
Clinical support services (e.g., social work, psychiatry, therapy) for individuals with mood or anxiety disorders

[Time Frame: 12 months after expected delivery date]
18. Rate of antidepressant use among individuals with mood or anxiety disorders New or continued antidepressant prescription use
[Time Frame: 4 months after expected delivery date]
19. Rate of antidepressant use among individuals with mood or anxiety disorders New or continued antidepressant prescription use
[Time Frame: 12 months after expected delivery date]
20. Rate of antihypertensive use among individuals with hypertension
New or continued antihypertensive medication use among individuals with hypertension [Time Frame: 4 months after expected delivery date]
21. Rate of antihypertensive use among individuals with hypertension
New or continued antihypertensive medication use among individuals with hypertension [Time Frame: 12 months after expected delivery date]
22. Rate of medication use for glycemic control among individuals with diabetes
New or continued oral or subcutaneous diabetes medication use control among individuals with diabetes [Time Frame: 4 months after expected delivery date]
23. Rate of medication use for glycemic control among individuals with diabetes
New or continued oral or subcutaneous diabetes medication use control among individuals with diabetes [Time Frame: 12 months after expected delivery date]
24. Rate of assessment of glycemic control among individuals with or at risk for diabetes
Laboratory glucose screening test among individuals with or at risk for diabetes [Time Frame: 4 months after expected delivery date]
25. Rate of assessment of glycemic control among individuals with or at risk for diabetes
Laboratory glucose screening test among individuals with or at risk for diabetes [Time Frame: 12 months after expected delivery date]
26. Rate of patient-reported primary care visit attendance
Primary care provider visit attendance per patient report [Time Frame: 4 months after expected delivery date]
27. Rate of patient-reported primary care visit attendance
Primary care provider visit attendance per patient report [Time Frame: 12 months after expected delivery date]
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
Eligibility 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 consent 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

Patients meeting eligibility criteria will be approached for consent into the study and a baseline survey during their prenatal visit or early postpartum visit. Random assignment will based on a pre-determined randomized sequence within strata.
Control Group:
Approximately 2 weeks before a patient’s estimated due date (EDD) or as soon as enrolled if this date has passed, the patient will be sent information via the Patient Gateway on the importance of postpartum care and follow-up with their PCP.
Intervention Group:
1. Tailored Information:
Approximately 2-4 weeks prior to the EDD (or later for those who are enrolled beyond 38 weeks gestation or postnatally), the patient will be sent an information via the Patient Gateway on the importance of postpartum care and follow-up with their PCP, which also includes the name and phone number of their primary care provider.
2. Scheduled PCP Appointment:
Between 2-3 weeks after their delivery, the RA will call the patient’s PCP office and make an appointment for them between 3-4 months after delivery based on the scheduling preferences obtained in the initial survey.
3. Targeted Appointment Message with Salient Labeling:
After the PCP appointment has been made, the patient will be sent a Patient Gateway message saying that a PCP appointment has been reserved for them with the date/time/location information.
For those consenting to receive SMS messages, an unencrypted text message will also be sent simultaneously.
4. Nudge Reminders:
Patient Gateway messages will be sent at approximately 4-8 weeks (goal: 4 weeks) and 1-4 week (goal: 1 week) prior to their PCP appointment, reminding a patient of their upcoming appointment.
For those consenting to receive SMS messages, an unencrypted text message will also be sent simultaneously.
5. Facilitated PCP Communication:
A study staff member will send the patient’s PCP an Epic Inbasket message that the patient 1) is recently postpartum, 2) has or developed health conditions that need long-term management, and 3) has been scheduled (or attempted to be scheduled) for a follow-up visit.

Outcomes will be assessed via electronic health records and an endline survey, conducted roughly 4-5 months after the expected delivery date.
Experimental Design Details
Not available
Randomization Method
A random allocation sequence to treatment or control with equal probability will be generated within each strata. Patients will be allocated to arms based on the timing of enrollment within their strata.
Randomization Unit
Individual
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
350-400 individuals
Sample size: planned number of observations
350-400 individuals
Sample size (or number of clusters) by treatment arms
175-200 individuals per arm
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Based on a chart review of delivery patients from previous years, we estimate that 15% of the control group will have a primary care provider appointment within 4 months (our primary outcome). With alpha of 0.05, power of 0.80, and a sample size of 350, our minimum detectable effect size (i.e. difference between treatment and control rate of primary care use) is 12.2 percentage points .
IRB

Institutional Review Boards (IRBs)

IRB Name
Mass General Brigham Institutional Review Board
IRB Approval Date
2022-09-14
IRB Approval Number
2022P001723