Clinical trial NCT04660032: Nudge to Drive Transitions of Care
Official title: Randomized Evaluation of Hypertensive Moms: Interventional Nudge to Drive Transitions of Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preeclampsia
Preeclampsia Severe
Gestational Hypertension
Hypertensive Disorder of Pregnancy
Superimposed Pre-Eclampsia
Keywords: Nudge
Postpartum
Fourth trimester
Cardiovascular disease
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2020-12-09
Enrollment: 224
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Hypertensive disorders of pregnancy (HDP) are stress tests which may identify women at high risk of future cardiovascular disease (CVD), the leading cause of death among women. Given the public health impact of HDP and CVD, there is a compelling need to identify scalable interventions to improve preventative care among women who have risk identified during pregnancy. We will examine the effects of delivering electronic prompts to obstetric care providers (nudge) on transitions of care in the postpartum period. We will conduct a pilot randomized trial to evaluate whether this nudge intervention will improve postpartum counseling and lead to greater follow-up with preventative care providers among women with HDP.

Detailed description: Background:

Women with HDP need ongoing care in the postpartum and inter-pregnancy period. HDP, including preeclampsia (PEC) and gestational hypertension (GHTN), complicate up to 10% of all pregnancies and are associated with immediate and long-term cardiovascular morbidity and mortality. HDP increase lifelong risk for chronic hypertension, diabetes, ischemic heart disease, stroke, and heart failure. Black women have a higher incidence of HDP and have a disproportionately higher morbidity and mortality compared to non-black women. The American College of Obstetricians and Gynecologists (ACOG) and the American Heart Association (AHA) emphasize the postpartum period as an important opportunity to identify and intervene upon women at high-risk for future cardiovascular disease (CVD).

However, current postpartum practices inadequately address transitions of care for women with HDP. A significant proportion of women with HDP do not see a preventative care provider (primary care, cardiology) in the months after delivery. Black women are particularly vulnerable to being lost to follow-up after complicated pregnancy. The HSM program is an innovative, patient-centered program that monitors postpartum blood pressure remotely using a text-based interface. It is supported by the Way to Health platform. HSM improves blood pressure management in the two weeks after delivery and eliminates racial disparities in blood pressure ascertainment during that time. However, enrollment in HSM did not improve follow-up in the year after delivery, with less than 1/3 of women having a preventative care visit. Poor follow-up is likely multifactorial, but may be driven by inadequate patient counseling in the postpartum period. Among women enrolled in HSM, only 21% of women were counseled on follow-up with primary care and only 4% were counseled on CVD risk at their postpartum visits based on chart review.

Nudges are effective for changing medical decision-making and improving clinical outcomes. Nudges utilize concepts from behavioral economics to subtly change the decision-making environment to facilitate evidence-based care and can be delivered to patients, providers, or both. Examples of nudges include electronic prompts to order cancer screening and electronic defaults that guide ordering practices. Nudges are low cost, scalable using Electronic Medical Record (EMR) systems, and improve rates of preventative services including influenza vaccination, referral to mammography, and statin prescription for CVD prevention.

Design:

This study will use a randomized, controlled superiority trial to evaluate a hospital-wide initiative to improve counseling for postpartum women who experienced HDP during their pregnancy or in the immediate postpartum period.

Hypotheses:

1. The investigators hypothesize that the prompt will increase the proportion of women counseled on transitioning care to a primary care provider or cardiologist after pregnancy (primary outcome).
2. The investigators hypothesize that the provider nudge will increase the proportion of women attending a preventative care visit within 6 months of delivery as assessed by chart review and patient surveys.

The HSM daily log generated through the Way to Health platform will be used to generate lists of patients who are eligible for the study. For each eligible woman, the date of and obstetric care provider for her postpartum visit will be recorded within 3 weeks of delivery.

Patients will then be randomly assigned to a control group with no intervention (usual care through HSM) or the intervention group (physician nudge) using simple 1:1 randomization through the Way to Health Platform. If a woman is randomized to the intervention arm, her obstetric care provider for her postpartum visit will receive a staff message in Epic (Penn Chart) that the provider's patient has an upcoming postpartum visit. The message will be sent 1 week before the scheduled visit. The message will have patient-specific information including hypertensive diagnosis, blood pressure medication(s), gestational diabetes diagnosis, and primary care provider as listed in the Epic banner. The message will also have dot phrases for recommended counseling and contact information for University of Pennsylvania Health System (UPHS) primary care and cardiology providers. There will be a dot phrase recommending follow-up with primary care or cardiology; counseling on risk of future CVD; and recommending aspirin in a future pregnancy.

A web-based survey will be distributed to all women in the study 6 months after delivery through the Way to Health platform. The survey will assess attendance at a preventative care visit, social determinants of health, health status, and insurance status after delivery.

Demographic characteristics, medical and obstetric history, hypertensive disorder, laboratory test results (platelet count, creatinine, liver function tests, urine protein, total cholesterol, triglycerides, LDL-C, HDL-C, glucose, hemoglobin A1c), blood pressure measurements, height, weight, and office visits within 6 months of delivery will be abstracted from the EMR. Detailed chart abstraction will be performed regarding counseling at the postpartum visit and additional office visits within 6 months of delivery focusing on 1) health maintenance 2) hypertension, or 3) cardiovascular risk reduction. Two reviewers will assess counseling at each visit. The investigators will obtain data on obstetric care providers including level (resident physician, attending physician, nurse practitioner, physician assistant, or certified nurse midwife), gender, and years in practice from publicly available databases or websites online.

Eligibility criteria: Inclusion Criteria:

1. At least 18 years old.
2. Have a diagnosis of HDP during delivery admission or have a diagnosis made at time of evaluation in the Perinatal Evaluation and Treatment Unit after discharge from the delivery admission. HDP diagnoses are based on criteria from the American College of Obstetricians and Gynecologists (ACOG).
3. Enrolled in Heart Safe Motherhood at Pennsylvania Hospital.
4. Have a postpartum visit with a University of Pennsylvania HealthSystem provider scheduled 4-12 weeks after delivery.

Exclusion Criteria:

1. Women diagnosed with chronic hypertension (CHTN) without superimposed pre-eclampsia (PEC).

Primary outcomes:
measure: Number of Patients With Documented Counseling on Transitions of Care
timeFrame: 4-12 weeks postpartum
Secondary outcomes:
measure: Nudge Message Opened Within 1 Week of Receipt
timeFrame: Prior to postpartum visit
measure: Number of Patients With Documented Counseling on Cardiovascular Disease (CVD) Risk at the Postpartum Visit
timeFrame: 4-12 weeks postpartum
measure: Number of Participants With Postpartum Visit Notes That Used Example Text
timeFrame: 4-12 weeks postpartum
measure: Number of Patients With Preventative Care Follow-up
timeFrame: 6 months postpartum
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Jourdan E Triebwasser, MD
role: PRINCIPAL_INVESTIGATOR
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