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Nudge to Drive Transitions of Care

Randomized Evaluation of Hypertensive Moms: Interventional Nudge to Drive Transitions of Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04660032
Acronym
REMIND
Enrollment
224
Registered
2020-12-09
Start date
2021-02-08
Completion date
2023-04-20
Last updated
2024-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Hypertension, Hypertensive Disorder of Pregnancy, Preeclampsia, Preeclampsia Severe, Superimposed Pre-Eclampsia

Keywords

Nudge, Postpartum, Fourth trimester, Cardiovascular disease

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.

Interventions

BEHAVIORALNudge

An electronic prompt (nudge) will be sent to the participant's obstetric care provider. The provider will receive a staff message in Epic (Penn Chart) that his/her 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 UPHS primary care and cardiology providers. There will be example text recommending follow-up with primary care or cardiology; counseling on risk of future CVD; and recommending aspirin in a future pregnancy.

Sponsors

University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Masking description

The participant will be unaware of whether their obstetric provider received an electronic prompt.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Number of Patients With Documented Counseling on Transitions of Care4-12 weeks postpartumThe primary outcome measure is documentation of counseling about transitioning care to a continuity care provider (primary care or cardiology) at the postpartum visit.

Secondary

MeasureTime frameDescription
Nudge Message Opened Within 1 Week of ReceiptPrior to postpartum visitElectronic prompts opened by obstetric care providers within 1 week of receipt in the electronic medical record. The nudge (electronic prompt) was sent 1 week prior to the scheduled 4-12 weeks postpartum visit.
Number of Patients With Documented Counseling on Cardiovascular Disease (CVD) Risk at the Postpartum Visit4-12 weeks postpartumDocumentation in the postpartum visit note regarding ongoing cardiovascular risk related to HDP
Number of Participants With Postpartum Visit Notes That Used Example Text4-12 weeks postpartumUse of scripted dot phrases (available in Epic) for counseling on transitions of care and CVD risk in the postpartum note. These dot phrases were available for all providers and were included in the nudge message.
Number of Patients With Preventative Care Follow-up6 months postpartumAttendance at a primary care or cardiology visit for preventative care within 6 months of delivery.

Countries

United States

Participant flow

Participants by arm

ArmCount
Nudge
Obstetric care providers will receive electronic prompts (nudge) for participants in this arm Nudge: An electronic prompt (nudge) will be sent to the participant's obstetric care provider. The provider will receive a staff message in Epic (Penn Chart) that his/her 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 UPHS primary care and cardiology providers. There will be example text recommending follow-up with primary care or cardiology; counseling on risk of future CVD; and recommending aspirin in a future pregnancy.
104
Usual Care
Usual postpartum follow-up with visit at 4-12 weeks postpartum
118
Total222

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyProtocol Violation11

Baseline characteristics

CharacteristicNudgeTotalUsual Care
Age, Continuous32.0 years
STANDARD_DEVIATION 5.5
32.3 years
STANDARD_DEVIATION 5.7
32.7 years
STANDARD_DEVIATION 5.2
Body mass index at first prenatal visit28.0 kg/m^227.8 kg/m^227.5 kg/m^2
Chronic hypertension9 Participants23 Participants14 Participants
Diabetes7 Participants26 Participants19 Participants
Gestational age at delivery (weeks)38.5 weeks38.5 weeks38.5 weeks
History of hypertensive disorder of pregnancy22 Participants54 Participants32 Participants
Hypertensive disorder of pregnancy
Chronic hypertension with superimposed preeclampsia
9 Participants22 Participants13 Participants
Hypertensive disorder of pregnancy
Gestational hypertension or preeclampsia
75 Participants160 Participants85 Participants
Hypertensive disorder of pregnancy
Hemolysis, elevated liver enzymes, and low platelet (HELLP) syndrome
0 Participants1 Participants1 Participants
Hypertensive disorder of pregnancy
Preeclampsia with severe features
20 Participants39 Participants19 Participants
Nulliparity64 Participants133 Participants69 Participants
Public insurance32 Participants69 Participants37 Participants
Race/Ethnicity, Customized
Asian
4 Participants11 Participants7 Participants
Race/Ethnicity, Customized
Black
34 Participants65 Participants31 Participants
Race/Ethnicity, Customized
Hispanic or Latinx
7 Participants13 Participants6 Participants
Race/Ethnicity, Customized
Multiple races/ethnicities
2 Participants6 Participants4 Participants
Race/Ethnicity, Customized
Not Reported
0 Participants3 Participants3 Participants
Race/Ethnicity, Customized
White
57 Participants124 Participants67 Participants
Region of Enrollment
United States
104 participants222 participants118 participants
Sex: Female, Male
Female
104 Participants222 Participants118 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants
Tobacco use5 Participants10 Participants5 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

Number of Patients With Documented Counseling on Transitions of Care

The primary outcome measure is documentation of counseling about transitioning care to a continuity care provider (primary care or cardiology) at the postpartum visit.

Time frame: 4-12 weeks postpartum

Population: Analyzed for study participants who attended postpartum visit

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
NudgeNumber of Patients With Documented Counseling on Transitions of Care38 Participants
Usual CareNumber of Patients With Documented Counseling on Transitions of Care28 Participants
Secondary

Nudge Message Opened Within 1 Week of Receipt

Electronic prompts opened by obstetric care providers within 1 week of receipt in the electronic medical record. The nudge (electronic prompt) was sent 1 week prior to the scheduled 4-12 weeks postpartum visit.

Time frame: Prior to postpartum visit

Population: A nudge was only sent for the intervention group; it was not sent nor measured for usual care.~A single nudge message was sent to the scheduled postpartum care provider per patient in the intervention group. A single provider could receive more than 1 nudge if they had more than 1 patient who was included in the study.

ArmMeasureValue (COUNT_OF_UNITS)
NudgeNudge Message Opened Within 1 Week of Receipt104 Nudge
Usual CareNudge Message Opened Within 1 Week of Receipt0 Nudge
Secondary

Number of Participants With Postpartum Visit Notes That Used Example Text

Use of scripted dot phrases (available in Epic) for counseling on transitions of care and CVD risk in the postpartum note. These dot phrases were available for all providers and were included in the nudge message.

Time frame: 4-12 weeks postpartum

Population: Attended postpartum visit

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
NudgeNumber of Participants With Postpartum Visit Notes That Used Example Text11 Participants
Usual CareNumber of Participants With Postpartum Visit Notes That Used Example Text1 Participants
Secondary

Number of Patients With Documented Counseling on Cardiovascular Disease (CVD) Risk at the Postpartum Visit

Documentation in the postpartum visit note regarding ongoing cardiovascular risk related to HDP

Time frame: 4-12 weeks postpartum

Population: 98 of 104 patients in the nudge arm (6 lost to follow-up) and 107 of 118 (11 lost to follow-up) patients in the usual care arm attended a postpartum visit within the health system and could be evaluated for this secondary outcome.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
NudgeNumber of Patients With Documented Counseling on Cardiovascular Disease (CVD) Risk at the Postpartum Visit21 Participants
Usual CareNumber of Patients With Documented Counseling on Cardiovascular Disease (CVD) Risk at the Postpartum Visit9 Participants
Secondary

Number of Patients With Preventative Care Follow-up

Attendance at a primary care or cardiology visit for preventative care within 6 months of delivery.

Time frame: 6 months postpartum

Population: Entire enrolled population who met inclusion/exclusion criteria

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
NudgeNumber of Patients With Preventative Care Follow-up23 Participants
Usual CareNumber of Patients With Preventative Care Follow-up29 Participants

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026