Nudge to Drive Transitions of Care

NCT04660032 | Completed Results

• 1 other identifier: 844269
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Nudge; Postpartum; Fourth trimester; Cardiovascular disease

Outcome Measures

Primary Outcomes (1)

• 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.

  4-12 weeks postpartum

Secondary Outcomes (4)

• Nudge Message Opened Within 1 Week of Receipt

  Prior to postpartum visit

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

  4-12 weeks postpartum

• Number of Participants With Postpartum Visit Notes That Used Example Text

  4-12 weeks postpartum

• Number of Patients With Preventative Care Follow-up

  6 months postpartum

Study Arms (2)

Nudge

EXPERIMENTAL

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

Behavioral: Nudge

Usual care

NO INTERVENTION

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

Interventions

Nudge BEHAVIORAL

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.

Nudge

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (21)

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  PMID: 21333604 BACKGROUND

• 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.

  PMID: 28701338 BACKGROUND

• 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.

  PMID: 26391409 BACKGROUND

• 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.

  PMID: 27400006 BACKGROUND

• 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.

  PMID: 28228456 BACKGROUND

• 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.

  PMID: 30786794 BACKGROUND

• 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.

  PMID: 20597458 BACKGROUND

• ACOG Committee Opinion No. 736: Optimizing Postpartum Care. Obstet Gynecol. 2018 May;131(5):e140-e150. doi: 10.1097/AOG.0000000000002633.

  PMID: 29683911 BACKGROUND

• 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.

  PMID: 29748185 BACKGROUND

• 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.

  PMID: 24474651 BACKGROUND

• 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.

  PMID: 27583396 BACKGROUND

• 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.

  PMID: 32851901 BACKGROUND

• 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.

  PMID: 29703800 BACKGROUND

• 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.

  PMID: 31121137 BACKGROUND

• 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.

  PMID: 31406293 BACKGROUND

• 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.

  PMID: 31541658 BACKGROUND

• 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.

  PMID: 28337690 BACKGROUND

• 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.

  PMID: 31406294 BACKGROUND

• 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.

  PMID: 31730186 BACKGROUND

• 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.

  PMID: 30646039 BACKGROUND

• Triebwasser JE, Lewey J, Walheim L, Sehdev HM, Srinivas SK. Electronic Reminder to Transition Care After Hypertensive Disorders of Pregnancy: A Randomized Controlled Trial. Obstet Gynecol. 2023 Jul 1;142(1):91-98. doi: 10.1097/AOG.0000000000005237. Epub 2023 Jun 7.

  PMID: 37294089 DERIVED

MeSH Terms

Conditions

Pre-Eclampsia; Hypertension, Pregnancy-Induced; Toxemia; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Infections

Results Point of Contact

• Title: Dr. Jourdan Triebwasser
• Organization: University of Michigan

jtriebwa@med.umich.edu

734-764-1406

Study Officials

• Jourdan E Triebwasser, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participant will be unaware of whether their obstetric provider received an electronic prompt.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: December 9, 2020
• Study Start: February 8, 2021
• Primary Completion: June 22, 2022
• Study Completion: April 20, 2023
• Last Updated: August 5, 2024
• Results First Posted: August 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)