Bridging the Gap From Postpartum to Primary Care
Primary Purpose
Hypertension, Hypertension in Pregnancy, Diabetes Mellitus
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Default appointment scheduling
Targeted messaging
Nudge Reminders
Sponsored by
About this trial
This is an interventional other trial for Hypertension focused on measuring Postpartum Care, Primary Care, Care Transitions
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
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Facilitated Transition
Arm Description
Routine postpartum care
Behavioral science informed interventions to assist in the transition from postpartum to primary care providers
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
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
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
Rate of visit unscheduled health care visit/encounter by the time of outcome assessment
Any visit to a urgent care or emergency room visit
Rate of visit unscheduled health care visit/encounter
Any visit to a urgent care or emergency room visit
Rate of contraception plan documented by the time of outcome assessment
Contraception plan documented by any provider after delivery
Rate of long-acting contraception use at time of outcome assessment
Long-acting contraception use (implant, intrauterine device)
Rate of long-acting contraception use
Long-acting contraception use (implant, intrauterine device)
Rate of contraception plan documented
Contraception plan documented by any provider after delivery
Rate of pregestational diabetes screening among individuals with gestational diabetes
Postpartum diabetes screening among those diagnosed with gestational diabetes
Rate of pregestational diabetes screening among individuals with gestational diabetes
Postpartum diabetes screening among those diagnosed with gestational diabetes
Rate of weight counseling documented in the health record among those with obesity
Weight counseling documentation among those with obesity
Rate of weight counseling documented in the health record among those with obesity
Weight counseling documentation among those with obesity
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
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
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
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
Rate of antidepressant use among individuals with mood or anxiety disorders
New or continued antidepressant prescription use
Rate of antidepressant use among individuals with mood or anxiety disorders
New or continued antidepressant prescription use
Rate of antihypertensive use among individuals with hypertension
New or continued antihypertensive medication use among individuals with hypertension
Rate of antihypertensive use among individuals with hypertension
New or continued antihypertensive medication use among individuals with hypertension
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
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
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
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
Rate of patient-reported primary care visit attendance
Primary care provider visit attendance per patient report
Rate of patient-reported primary care visit attendance
Primary care provider visit attendance per patient report
Full Information
NCT ID
NCT05543265
First Posted
September 6, 2022
Last Updated
October 17, 2023
Sponsor
Massachusetts General Hospital
Collaborators
National Institute on Aging (NIA), National Bureau of Economic Research, Inc., Massachusetts Institute of Technology
1. Study Identification
Unique Protocol Identification Number
NCT05543265
Brief Title
Bridging the Gap From Postpartum to Primary Care
Official Title
Bridging the Gap From Postpartum to Primary Care: A Behavioral Science Informed Intervention to Improve Chronic Disease Management Among Postpartum Women
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 3, 2022 (Actual)
Primary Completion Date
October 11, 2023 (Actual)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Institute on Aging (NIA), National Bureau of Economic Research, Inc., Massachusetts Institute of Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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:
Targeted messages about the importance and benefits of primary care
Default scheduling into a primary care appointment at approximately 3-4 months after delivery
Reminders about the appointment and importance of follow up primary care at 2-4 points during the postpartum period via the patient portal
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.
Salient labeling on follow-up appointments
Direct PCP messaging about the scheduled follow-up
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Hypertension in Pregnancy, Diabetes Mellitus, Gestational Diabetes, Obesity, Depressive Disorder, Anxiety Disorders
Keywords
Postpartum Care, Primary Care, Care Transitions
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
360 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Routine postpartum care
Arm Title
Facilitated Transition
Arm Type
Experimental
Arm Description
Behavioral science informed interventions to assist in the transition from postpartum to primary care providers
Intervention Type
Behavioral
Intervention Name(s)
Default appointment scheduling
Intervention Description
Default primary care appointment scheduling
Intervention Type
Behavioral
Intervention Name(s)
Targeted messaging
Intervention Description
Patient-specific messages about the importance of postpartum care transition
Intervention Type
Behavioral
Intervention Name(s)
Nudge Reminders
Intervention Description
Primary care appointment reminders
Primary Outcome Measure Information:
Title
Rate of primary care provider visit attendance
Description
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
4 months after the patient's estimated date of delivery
Secondary Outcome Measure Information:
Title
Rate of primary care provider visit attendance
Description
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 the patient's estimated date of delivery
Title
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)
Description
Health care maintenance visit appointment with the patient's assigned primary care provider
Time Frame
4 months after the patient's estimated date of delivery
Title
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)
Description
Health care maintenance visit appointment with the patient's assigned primary care provider
Time Frame
12 months after the patient's estimated date of delivery
Title
Rate of visit unscheduled health care visit/encounter by the time of outcome assessment
Description
Any visit to a urgent care or emergency room visit
Time Frame
4 months after the patient's estimated date of delivery
Title
Rate of visit unscheduled health care visit/encounter
Description
Any visit to a urgent care or emergency room visit
Time Frame
12 months after the patient's estimated date of delivery
Title
Rate of contraception plan documented by the time of outcome assessment
Description
Contraception plan documented by any provider after delivery
Time Frame
4 months after the patient's estimated date of delivery
Title
Rate of long-acting contraception use at time of outcome assessment
Description
Long-acting contraception use (implant, intrauterine device)
Time Frame
4 months after the patient's estimated date of delivery
Title
Rate of long-acting contraception use
Description
Long-acting contraception use (implant, intrauterine device)
Time Frame
12 months after the patient's estimated date of delivery
Title
Rate of contraception plan documented
Description
Contraception plan documented by any provider after delivery
Time Frame
12 months after the patient's estimated date of delivery
Title
Rate of pregestational diabetes screening among individuals with gestational diabetes
Description
Postpartum diabetes screening among those diagnosed with gestational diabetes
Time Frame
4 months after the patient's estimated date of delivery
Title
Rate of pregestational diabetes screening among individuals with gestational diabetes
Description
Postpartum diabetes screening among those diagnosed with gestational diabetes
Time Frame
12 months after the patient's estimated date of delivery
Title
Rate of weight counseling documented in the health record among those with obesity
Description
Weight counseling documentation among those with obesity
Time Frame
4 months after the patient's estimated date of delivery
Title
Rate of weight counseling documented in the health record among those with obesity
Description
Weight counseling documentation among those with obesity
Time Frame
12 months after the patient's estimated date of delivery
Title
Rate of blood pressure measurement documented in the health record among those with or at risk for hypertension
Description
Blood pressure documented in the EHR among those diagnosed within chronic or pregnancy-related hypertension
Time Frame
4 months after the patient's estimated date of delivery
Title
Rate of blood pressure measurement documented in the health record among those with or at risk for hypertension
Description
Blood pressure documented in the EHR among those diagnosed within chronic or pregnancy-related hypertension
Time Frame
12 months after the patient's estimated date of delivery
Title
Rate of mental health service referral or use among individuals with mood or anxiety disorders
Description
Clinical support services (e.g., social work, psychiatry, therapy) for individuals with mood or anxiety disorders
Time Frame
4 months after the patient's estimated date of delivery
Title
Rate of mental health service referral or use among individuals with mood or anxiety disorders
Description
Clinical support services (e.g., social work, psychiatry, therapy) for individuals with mood or anxiety disorders
Time Frame
12 months after the patient's estimated date of delivery
Title
Rate of antidepressant use among individuals with mood or anxiety disorders
Description
New or continued antidepressant prescription use
Time Frame
4 months after the patient's estimated date of delivery
Title
Rate of antidepressant use among individuals with mood or anxiety disorders
Description
New or continued antidepressant prescription use
Time Frame
12 months after the patient's estimated date of delivery
Title
Rate of antihypertensive use among individuals with hypertension
Description
New or continued antihypertensive medication use among individuals with hypertension
Time Frame
4 months after the patient's estimated date of delivery
Title
Rate of antihypertensive use among individuals with hypertension
Description
New or continued antihypertensive medication use among individuals with hypertension
Time Frame
12 months after the patient's estimated date of delivery
Title
Rate of medication use for glycemic control among individuals with diabetes
Description
New or continued oral or subcutaneous diabetes medication use control among individuals with diabetes
Time Frame
4 months after the patient's estimated date of delivery
Title
Rate of medication use for glycemic control among individuals with diabetes
Description
New or continued oral or subcutaneous diabetes medication use control among individuals with diabetes
Time Frame
12 months after the patient's estimated date of delivery
Title
Rate of assessment of glycemic control among individuals with or at risk for diabetes
Description
Laboratory glucose screening test among individuals with or at risk for diabetes
Time Frame
4 months after the patient's estimated date of delivery
Title
Rate of assessment of glycemic control among individuals with or at risk for diabetes
Description
Laboratory glucose screening test among individuals with or at risk for diabetes
Time Frame
12 months after the patient's estimated date of delivery
Title
Rate of patient-reported primary care visit attendance
Description
Primary care provider visit attendance per patient report
Time Frame
4 months after the patient's estimated date of delivery
Title
Rate of patient-reported primary care visit attendance
Description
Primary care provider visit attendance per patient report
Time Frame
12 months after the patient's estimated date of delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark A Clapp, MD, MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jessica L Cohen, PhD
Organizational Affiliation
Harvard School of Public Health (HSPH)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Bridging the Gap From Postpartum to Primary Care
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