Anxiety Disorders, Depressive Disorder, Diabetes Mellitus, Gestational Diabetes, Hypertension, Hypertension in Pregnancy, Obesity
Conditions
Keywords
Postpartum Care, Primary Care, Care Transitions
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: 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
Interventions
BEHAVIORALDefault appointment scheduling
Default primary care appointment scheduling
BEHAVIORALTargeted messaging
Patient-specific messages about the importance of postpartum care transition
BEHAVIORALNudge Reminders
Primary care appointment reminders
Sponsors
National Institute on Aging (NIA)
National Bureau of Economic Research, Inc.
Massachusetts Institute of Technology
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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) |
| Rate of Long-acting Contraception Use | 12 months after the patient's estimated date of delivery | Long-acting contraception use (implant, intrauterine device) |
| 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 |
| Rate of Contraception Plan Documented | 12 months after the patient's estimated date of delivery | Contraception plan documented by any provider after delivery |
| 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) |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Routine postpartum care | 173 |
| Facilitated Transition Behavioral science informed interventions to assist in the transition from postpartum to primary care providers
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 | 180 |
| Total | 353 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 3 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Control | Total | Facilitated Transition |
|---|---|---|---|
| Age, Continuous | 34.0 years STANDARD_DEVIATION 5 | 34.1 years STANDARD_DEVIATION 4.9 | 34.2 years STANDARD_DEVIATION 4.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 41 Participants | 78 Participants | 37 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 127 Participants | 266 Participants | 139 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 9 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 00 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 13 Participants | 24 Participants | 11 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 26 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 28 Participants | 53 Participants | 25 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 8 Participants | 3 Participants |
| Race (NIH/OMB) White | 115 Participants | 242 Participants | 127 Participants |
| Region of Enrollment United States | 173 participants | 353 participants | 180 participants |
| Sex: Female, Male Female | 173 Participants | 353 Participants | 180 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 173 | 0 / 180 |
| other Total, other adverse events | 0 / 173 | 0 / 180 |
| serious Total, serious adverse events | 0 / 173 | 0 / 180 |
Outcome results
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)
Time frame: 4 months after the patient's estimated date of delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Rate of Primary Care Provider Visit Attendance | 38 Participants |
| Facilitated Transition | Rate of Primary Care Provider Visit Attendance | 72 Participants |
p-value: <0.00195% CI: [6.4, 28.8]Chi-squared
Secondary
Rate of Antidepressant Use Among Individuals With Mood or Anxiety Disorders
New or continued antidepressant prescription use
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 months after the patient's estimated date of delivery
Secondary
Rate of Contraception Plan Documented
Contraception plan documented by any provider after delivery
Time frame: 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
Time frame: 4 months after the patient's estimated date of delivery
Secondary
Rate of Long-acting Contraception Use
Long-acting contraception use (implant, intrauterine device)
Time frame: 12 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 12 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
Time frame: 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
Time frame: 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
Time frame: 4 months after the patient's estimated date of delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | 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) | 30 Participants |
| Facilitated Transition | 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) | 58 Participants |
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
Time frame: 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
Time frame: 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
Time frame: 4 months after the patient's estimated date of delivery