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Nudge to Drive Transitions of Care (REMIND)

Primary Purpose

Preeclampsia, Preeclampsia Severe, Gestational Hypertension

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nudge
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Preeclampsia focused on measuring Nudge, Postpartum, Fourth trimester, Cardiovascular disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • Pennsylvania Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Nudge

Usual care

Arm Description

Obstetric care providers will receive electronic prompts (nudge) for participants in this arm

Usual postpartum follow-up with visit at 4-12 weeks postpartum

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of providers who access the nudge
Electronic prompts opened by obstetric care providers within 1 week of receipt in the electronic medical record
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
Number of postpartum visit notes using example text
Use of scripted dot phrases (available in Epic) for counseling on transitions of care and CVD risk in the postpartum note.
Number of patients with preventative care follow-up
Attendance at a primary care or cardiology visit for preventative care within 6 months of delivery.

Full Information

First Posted
December 2, 2020
Last Updated
November 21, 2022
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT04660032
Brief Title
Nudge to Drive Transitions of Care
Acronym
REMIND
Official Title
Randomized Evaluation of Hypertensive Moms: Interventional Nudge to Drive Transitions of Care
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 8, 2021 (Actual)
Primary Completion Date
June 22, 2022 (Actual)
Study Completion Date
March 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia, Preeclampsia Severe, Gestational Hypertension, Hypertensive Disorder of Pregnancy, Superimposed Pre-Eclampsia
Keywords
Nudge, Postpartum, Fourth trimester, Cardiovascular disease

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
The participant will be unaware of whether their obstetric provider received an electronic prompt.
Allocation
Randomized
Enrollment
222 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nudge
Arm Type
Experimental
Arm Description
Obstetric care providers will receive electronic prompts (nudge) for participants in this arm
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual postpartum follow-up with visit at 4-12 weeks postpartum
Intervention Type
Behavioral
Intervention Name(s)
Nudge
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of patients with documented counseling on transitions of care
Description
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
Secondary Outcome Measure Information:
Title
Number of providers who access the nudge
Description
Electronic prompts opened by obstetric care providers within 1 week of receipt in the electronic medical record
Time Frame
Prior to postpartum visit
Title
Number of patients with documented counseling on cardiovascular disease (CVD) risk at the postpartum visit
Description
Documentation in the postpartum visit note regarding ongoing cardiovascular risk related to HDP
Time Frame
4-12 weeks postpartum
Title
Number of postpartum visit notes using example text
Description
Use of scripted dot phrases (available in Epic) for counseling on transitions of care and CVD risk in the postpartum note.
Time Frame
4-12 weeks postpartum
Title
Number of patients with preventative care follow-up
Description
Attendance at a primary care or cardiology visit for preventative care within 6 months of delivery.
Time Frame
6 months postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 18 years old. 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). Enrolled in Heart Safe Motherhood at Pennsylvania Hospital. 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jourdan E Triebwasser, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pennsylvania Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21333604
Citation
Hutcheon JA, Lisonkova S, Joseph KS. Epidemiology of pre-eclampsia and the other hypertensive disorders of pregnancy. Best Pract Res Clin Obstet Gynaecol. 2011 Aug;25(4):391-403. doi: 10.1016/j.bpobgyn.2011.01.006. Epub 2011 Feb 18.
Results Reference
background
PubMed Identifier
28701338
Citation
Timpka S, Stuart JJ, Tanz LJ, Rimm EB, Franks PW, Rich-Edwards JW. Lifestyle in progression from hypertensive disorders of pregnancy to chronic hypertension in Nurses' Health Study II: observational cohort study. BMJ. 2017 Jul 12;358:j3024. doi: 10.1136/bmj.j3024.
Results Reference
background
PubMed Identifier
26391409
Citation
Cirillo PM, Cohn BA. Pregnancy complications and cardiovascular disease death: 50-year follow-up of the Child Health and Development Studies pregnancy cohort. Circulation. 2015 Sep 29;132(13):1234-42. doi: 10.1161/CIRCULATIONAHA.113.003901. Epub 2015 Sep 21.
Results Reference
background
PubMed Identifier
27400006
Citation
Theilen LH, Fraser A, Hollingshaus MS, Schliep KC, Varner MW, Smith KR, Esplin MS. All-Cause and Cause-Specific Mortality After Hypertensive Disease of Pregnancy. Obstet Gynecol. 2016 Aug;128(2):238-244. doi: 10.1097/AOG.0000000000001534.
Results Reference
background
PubMed Identifier
28228456
Citation
Wu P, Haththotuwa R, Kwok CS, Babu A, Kotronias RA, Rushton C, Zaman A, Fryer AA, Kadam U, Chew-Graham CA, Mamas MA. Preeclampsia and Future Cardiovascular Health: A Systematic Review and Meta-Analysis. Circ Cardiovasc Qual Outcomes. 2017 Feb;10(2):e003497. doi: 10.1161/CIRCOUTCOMES.116.003497. Epub 2017 Feb 22.
Results Reference
background
PubMed Identifier
30786794
Citation
Gyamfi-Bannerman C, Pandita A, Miller EC, Boehme AK, Wright JD, Siddiq Z, D'Alton ME, Friedman AM. Preeclampsia outcomes at delivery and race. J Matern Fetal Neonatal Med. 2020 Nov;33(21):3619-3626. doi: 10.1080/14767058.2019.1581522. Epub 2019 Feb 20.
Results Reference
background
PubMed Identifier
20597458
Citation
Miranda ML, Swamy GK, Edwards S, Maxson P, Gelfand A, James S. Disparities in maternal hypertension and pregnancy outcomes: evidence from North Carolina, 1994-2003. Public Health Rep. 2010 Jul-Aug;125(4):579-87. doi: 10.1177/003335491012500413.
Results Reference
background
PubMed Identifier
29683911
Citation
ACOG Committee Opinion No. 736: Optimizing Postpartum Care. Obstet Gynecol. 2018 May;131(5):e140-e150. doi: 10.1097/AOG.0000000000002633.
Results Reference
background
PubMed Identifier
29748185
Citation
Brown HL, Warner JJ, Gianos E, Gulati M, Hill AJ, Hollier LM, Rosen SE, Rosser ML, Wenger NK; American Heart Association and the American College of Obstetricians and Gynecologists. Promoting Risk Identification and Reduction of Cardiovascular Disease in Women Through Collaboration With Obstetricians and Gynecologists: A Presidential Advisory From the American Heart Association and the American College of Obstetricians and Gynecologists. Circulation. 2018 Jun 12;137(24):e843-e852. doi: 10.1161/CIR.0000000000000582. Epub 2018 May 10. No abstract available.
Results Reference
background
PubMed Identifier
24474651
Citation
Bennett WL, Chang HY, Levine DM, Wang L, Neale D, Werner EF, Clark JM. Utilization of primary and obstetric care after medically complicated pregnancies: an analysis of medical claims data. J Gen Intern Med. 2014 Apr;29(4):636-45. doi: 10.1007/s11606-013-2744-2. Epub 2014 Jan 29.
Results Reference
background
PubMed Identifier
27583396
Citation
Levine LD, Nkonde-Price C, Limaye M, Srinivas SK. Factors associated with postpartum follow-up and persistent hypertension among women with severe preeclampsia. J Perinatol. 2016 Dec;36(12):1079-1082. doi: 10.1038/jp.2016.137. Epub 2016 Sep 1.
Results Reference
background
PubMed Identifier
32851901
Citation
Lewey J, Levine LD, Yang L, Triebwasser JE, Groeneveld PW. Patterns of Postpartum Ambulatory Care Follow-up Care Among Women With Hypertensive Disorders of Pregnancy. J Am Heart Assoc. 2020 Sep;9(17):e016357. doi: 10.1161/JAHA.120.016357. Epub 2020 Aug 27.
Results Reference
background
PubMed Identifier
29703800
Citation
Hirshberg A, Downes K, Srinivas S. Comparing standard office-based follow-up with text-based remote monitoring in the management of postpartum hypertension: a randomised clinical trial. BMJ Qual Saf. 2018 Nov;27(11):871-877. doi: 10.1136/bmjqs-2018-007837. Epub 2018 Apr 27.
Results Reference
background
PubMed Identifier
31121137
Citation
Hirshberg A, Sammel MD, Srinivas SK. Text message remote monitoring reduced racial disparities in postpartum blood pressure ascertainment. Am J Obstet Gynecol. 2019 Sep;221(3):283-285. doi: 10.1016/j.ajog.2019.05.011. Epub 2019 May 20. No abstract available.
Results Reference
background
PubMed Identifier
31406293
Citation
Patel MS. Nudges for influenza vaccination. Nat Hum Behav. 2018 Oct;2(10):720-721. doi: 10.1038/s41562-018-0445-x. No abstract available.
Results Reference
background
PubMed Identifier
31541658
Citation
Patel MS, Navathe AS, Liao JM. Using Nudges to Improve Value by Increasing Imaging-Based Cancer Screening. J Am Coll Radiol. 2020 Jan;17(1 Pt A):38-41. doi: 10.1016/j.jacr.2019.08.025. Epub 2019 Sep 18. No abstract available.
Results Reference
background
PubMed Identifier
28337690
Citation
Patel MS, Volpp KG, Small DS, Wynne C, Zhu J, Yang L, Honeywell S Jr, Day SC. Using Active Choice Within the Electronic Health Record to Increase Influenza Vaccination Rates. J Gen Intern Med. 2017 Jul;32(7):790-795. doi: 10.1007/s11606-017-4046-6. Epub 2017 Mar 23.
Results Reference
background
PubMed Identifier
31406294
Citation
Yokum D, Lauffenburger JC, Ghazinouri R, Choudhry NK. Letters designed with behavioural science increase influenza vaccination in Medicare beneficiaries. Nat Hum Behav. 2018 Oct;2(10):743-749. doi: 10.1038/s41562-018-0432-2. Epub 2018 Oct 1.
Results Reference
background
PubMed Identifier
31730186
Citation
Hsiang EY, Mehta SJ, Small DS, Rareshide CAL, Snider CK, Day SC, Patel MS. Association of an Active Choice Intervention in the Electronic Health Record Directed to Medical Assistants With Clinician Ordering and Patient Completion of Breast and Colorectal Cancer Screening Tests. JAMA Netw Open. 2019 Nov 1;2(11):e1915619. doi: 10.1001/jamanetworkopen.2019.15619.
Results Reference
background
PubMed Identifier
30646039
Citation
Patel MS, Kurtzman GW, Kannan S, Small DS, Morris A, Honeywell S Jr, Leri D, Rareshide CAL, Day SC, Mahoney KB, Volpp KG, Asch DA. Effect of an Automated Patient Dashboard Using Active Choice and Peer Comparison Performance Feedback to Physicians on Statin Prescribing: The PRESCRIBE Cluster Randomized Clinical Trial. JAMA Netw Open. 2018 Jul 6;1(3):e180818. doi: 10.1001/jamanetworkopen.2018.0818.
Results Reference
background

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