Bridging the Gap From Postpartum to Primary Care

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05543265
• Other study ID #: 2022P001723
• Secondary ID: P30AG034532P30AG
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 3, 2022
• Est. completion date: June 2024

Study information

• Verified date: October 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 360
• Est. completion date: June 2024
• Est. primary completion date: October 11, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Default appointment scheduling
Default primary care appointment scheduling
• Targeted messaging
Patient-specific messages about the importance of postpartum care transition
• Nudge Reminders
Primary care appointment reminders

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (4)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	12 months after the patient's estimated date of delivery
Secondary	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	4 months after the patient's estimated date of delivery
Secondary	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	12 months after the patient's estimated date of delivery
Secondary	Rate of visit unscheduled health care visit/encounter by the time of outcome assessment	Any visit to a urgent care or emergency room visit	4 months after the patient's estimated date of delivery
Secondary	Rate of visit unscheduled health care visit/encounter	Any visit to a urgent care or emergency room visit	12 months after the patient's estimated date of delivery
Secondary	Rate of contraception plan documented by the time of outcome assessment	Contraception plan documented by any provider after delivery	4 months after the patient's estimated date of delivery
Secondary	Rate of long-acting contraception use at time of outcome assessment	Long-acting contraception use (implant, intrauterine device)	4 months after the patient's estimated date of delivery
Secondary	Rate of long-acting contraception use	Long-acting contraception use (implant, intrauterine device)	12 months after the patient's estimated date of delivery
Secondary	Rate of contraception plan documented	Contraception plan documented by any provider after delivery	12 months after the patient's estimated date of delivery
Secondary	Rate of pregestational diabetes screening among individuals with gestational diabetes	Postpartum diabetes screening among those diagnosed with gestational diabetes	4 months after the patient's estimated date of delivery
Secondary	Rate of pregestational diabetes screening among individuals with gestational diabetes	Postpartum diabetes screening among those diagnosed with gestational diabetes	12 months after the patient's estimated date of delivery
Secondary	Rate of weight counseling documented in the health record among those with obesity	Weight counseling documentation among those with obesity	4 months after the patient's estimated date of delivery
Secondary	Rate of weight counseling documented in the health record among those with obesity	Weight counseling documentation among those with obesity	12 months after the patient's estimated date of delivery
Secondary	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	4 months after the patient's estimated date of delivery
Secondary	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	12 months after the patient's estimated date of delivery
Secondary	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	4 months after the patient's estimated date of delivery
Secondary	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	12 months after the patient's estimated date of delivery
Secondary	Rate of antidepressant use among individuals with mood or anxiety disorders	New or continued antidepressant prescription use	4 months after the patient's estimated date of delivery
Secondary	Rate of antidepressant use among individuals with mood or anxiety disorders	New or continued antidepressant prescription use	12 months after the patient's estimated date of delivery
Secondary	Rate of antihypertensive use among individuals with hypertension	New or continued antihypertensive medication use among individuals with hypertension	4 months after the patient's estimated date of delivery
Secondary	Rate of antihypertensive use among individuals with hypertension	New or continued antihypertensive medication use among individuals with hypertension	12 months after the patient's estimated date of delivery
Secondary	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	4 months after the patient's estimated date of delivery
Secondary	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	12 months after the patient's estimated date of delivery
Secondary	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	4 months after the patient's estimated date of delivery
Secondary	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	12 months after the patient's estimated date of delivery
Secondary	Rate of patient-reported primary care visit attendance	Primary care provider visit attendance per patient report	4 months after the patient's estimated date of delivery
Secondary	Rate of patient-reported primary care visit attendance	Primary care provider visit attendance per patient report	12 months after the patient's estimated date of delivery