Remote Monitoring and Follow-up for Postpartum Hypertensive Disorders of Pregnancy
NCT ID: NCT05124327
Last Updated: 2023-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2022-03-07
2022-06-30
Brief Summary
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Telemedicine follow-up within 10 days of delivery (48-72 hours after discharge) reduces readmission rates, increase access to- and compliance with care, and improve patient safety satisfaction, thus establishing feasibility. Home vital sign monitoring gives an increased volume of data points for providers to utilize in titrating antihypertensive medications to optimize blood pressure control, ultimately decreasing stroke and cardiovascular risk. Existing research lacks comprehension regarding specific cardiological impacts of labile postpartum blood pressures, however researchers inferentially hypothesize that poor blood pressure management in the postpartum period can have devastating long-term cardiological consequences.
This QI project will demonstrate standardized programming for patients with hypertensive disorders of pregnancy (HDP), which may potentially lead to increased compliance, satisfaction, and accessibility, resulting in improved long-term cardiovascular health in vulnerable populations. The American heart Association (AHA) and ACOG have established that HDP are associated with long-term cardiovascular disease, however obstetricians lack guidance on effective, evidence-based research for standardization of care, leading to subsequently disjointed medical management with much room for error in transitioning from obstetrician to internist or cardiologist. Thus, implementing and establishing feasibility of remote monitoring and follow-up while applying standardized algorithms and protocols for antihypertensive medication titration and management may provide support in addressing and eradicating these gaps. As such, this pilot project has massive prospective future applicability and benefit for a highly vulnerable population.
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Detailed Description
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30 participants will be manually enrolled with Vytrack after eligibility is confirmed by the primary investigator. Participants will receive standard education on how to properly use Vytrack technology and prompted to check their vital signs twice daily (morning and night) or more per primary obstetrician preference until the end of their enrollment period (ten days postpartum), while additionally maintaining their primary obstetrician's standard care. Additionally, participants will be scheduled for a virtual medical appointment at 48-72 hours post hospital discharge for vital sign evaluation and optimization with a provider, employing an algorithm to titrate antihypertensive therapy as needed. The initial usage of antihypertensive therapy will be in accordance with the participant's care team as an inpatient.
The goal of this project is predominantly to establish feasibility of such programming in this large academic hospital setting through ascertaining retention rates over ten days postpartum as well as participant satisfaction, with a target of at least 90% retention and compliance rate and at least 80% satisfaction over traditional methods. Satisfaction will be analyzed through post-participation surveys, displaying Likert-scale style questions. Secondarily, through improved patient engagement in postpartum care and accessibility to standardized management, this QI project anticipates at least a 20% reduction in postpartum readmissions for hypertensive emergencies.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Intervention Group
Implementation of quality improvement initiative to utilize RPM in PP HDP. Patients will utilize remote monitoring technology and bluetooth enabled BP buff to self monitor BPs- autopopulate to provider portal, and then have a telemedicine appointment at 48 hours post hospital discharge.
QI project- usage of RPM
close monitoring through RPM to analyze feasibility and compare readmission rates
Interventions
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QI project- usage of RPM
close monitoring through RPM to analyze feasibility and compare readmission rates
Eligibility Criteria
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Inclusion Criteria
* aged 18 years or greater
* in the hospital after delivery
* any documented concern related to blood pressure elevation including preeclampsia, gestational hypertension, essential/chronic/pregestational hypertension, or new onset postpartum hypertension
* with or without lab abnormalities
* any gestational age
* English-speaking
* access to a smartphone device
Exclusion Criteria
* documented HELLP syndrome (hemolysis, elevated liver enzymes, low platelets)
* patients requiring a massive transfusion protocol (MTP)
* patients who underwent hysterectomies
* patients that were admitted to the ICU after delivery and patients who experienced fetal demise.
18 Years
FEMALE
No
Sponsors
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University of California, Los Angeles
OTHER
Cedars-Sinai Medical Center
OTHER
Responsible Party
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Margo B. Minissian
Executive Director
Principal Investigators
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Leah Spiro, FNP
Role: STUDY_DIRECTOR
Cedars-Sinai Medical Center
Locations
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Cedars Sinai Medical Center
Los Angeles, California, United States
Countries
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Related Links
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Assad, N., Drewry, A., Hoppe, K.K., Passmore, S.R., Thomas, N.A. (2021). Patient perceptions, opinions and satisfaction of telehealth with remote blood pressure monitoring postpartum. BMC Pregnancy Childbirth, 21: 153
Attenello, F.J., D'Alton, M., Friedman, A.M., Goffman, D., Mack, W.J., Wen, T., \& Wright, J.D. (2019). Hypertensive postpartum admissions among women without a history of hypertension or preeclampsia. Obstetrics and Gynecology, 133(4), 712-719.
Beigi, R.H., Binstock, A., Hauspurg, A., Hyagriv, S.N., Larkin, J., Lemon, L., Watson, A.R., \& Quinn, B.A. (2019). A postpartum remote hypertension monitoring protocol implemented at the hospital level. Obstetrics \& Gynecology, 134(4), 685-691.
Early postpartum discharge during the COVID-19 pandemic. Journal of Perinatal Medicine, 48(9), 1008-101
Castleman, J.S., Ganapathy, R., Grewal, A. (2016). Remote monitoring of blood pressure to reduce the risk of preeclampsia related complications with an innovative use of mobile technology. Pregnancy Hypertension, 6(4), 263-264.
Telehealth with remote blood pressure monitoring for postpartum hypertension: A prospective single-cohort feasibility study. Pregna
Exploring implementation of m-health monitoring in postpartum women with hypertension. Telemedicine Journal and E-Health, 23(10), 8
Lackan, N. A., Lykens, K., Mains, D.A., Sammer, C.E., \& Singh, K.P. (2010). What is patient safety culture? A review of the literature. Journal of Nursing Scholarship, 42(2), 156-165.
McFarlin, B.L., Mogos, M.F., Salemi, J. L., Salihu, H.H., \& Spooner, K.K. (2018). Hypertensive disorders of pregnancy and postpartum readmission in the United States national surveillance of the revolving door. Journal of Hypertension, 36(3), 608-618.
Other Identifiers
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STUDY00001570
Identifier Type: -
Identifier Source: org_study_id
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