N/A
N=360
Bridging the Gap From Postpartum to Primary Care
Hypertension · Hypertension in Pregnancy · Diabetes Mellitus · Gestational Diabetes · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT05543265 ↗Enrolled (actual)
360
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Rate of Primary Care Provider Visit Attendance — 38; 72 Participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Default appointment scheduling (Behavioral); Targeted messaging (Behavioral); Nudge Reminders (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Primary Care Provider Visit Attendance |
— | — |
| SECONDARY Rate of Primary Care Provider Visit Attendance |
— | — |
| 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) |
— | — |
| 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) |
— | — |
| SECONDARY Rate of Visit Unscheduled Health Care Visit/Encounter by the Time of Outcome Assessment |
— | — |
| SECONDARY Rate of Visit Unscheduled Health Care Visit/Encounter |
— | — |
| SECONDARY Rate of Contraception Plan Documented by the Time of Outcome Assessment |
— | — |
| SECONDARY Rate of Long-acting Contraception Use at Time of Outcome Assessment |
— | — |
| SECONDARY Rate of Long-acting Contraception Use |
— | — |
| SECONDARY Rate of Contraception Plan Documented |
— | — |
| SECONDARY Rate of Pregestational Diabetes Screening Among Individuals With Gestational Diabetes |
— | — |
| SECONDARY Rate of Pregestational Diabetes Screening Among Individuals With Gestational Diabetes |
— | — |
| SECONDARY Rate of Weight Counseling Documented in the Health Record Among Those With Obesity |
— | — |
| SECONDARY Rate of Weight Counseling Documented in the Health Record Among Those With Obesity |
— | — |
| SECONDARY Rate of Blood Pressure Measurement Documented in the Health Record Among Those With or at Risk for Hypertension |
— | — |
| SECONDARY Rate of Blood Pressure Measurement Documented in the Health Record Among Those With or at Risk for Hypertension |
— | — |
| SECONDARY Rate of Mental Health Service Referral or Use Among Individuals With Mood or Anxiety Disorders |
— | — |
| SECONDARY Rate of Mental Health Service Referral or Use Among Individuals With Mood or Anxiety Disorders |
— | — |
| SECONDARY Rate of Antidepressant Use Among Individuals With Mood or Anxiety Disorders |
— | — |
| SECONDARY Rate of Antidepressant Use Among Individuals With Mood or Anxiety Disorders |
— | — |
| SECONDARY Rate of Antihypertensive Use Among Individuals With Hypertension |
— | — |
| SECONDARY Rate of Antihypertensive Use Among Individuals With Hypertension |
— | — |
| SECONDARY Rate of Medication Use for Glycemic Control Among Individuals With Diabetes |
— | — |
| SECONDARY Rate of Medication Use for Glycemic Control Among Individuals With Diabetes |
— | — |
| SECONDARY Rate of Assessment of Glycemic Control Among Individuals With or at Risk for Diabetes |
— | — |
| SECONDARY Rate of Assessment of Glycemic Control Among Individuals With or at Risk for Diabetes |
— | — |
| SECONDARY Rate of Patient-reported Primary Care Visit Attendance |
— | — |
| SECONDARY Rate of Patient-reported Primary Care Visit Attendance |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT05543265). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.