Remote Monitoring and Follow-up for Postpartum Hypertensive Disorders of Pregnancy

Compliance and Satisfaction With a Remote Postpartum Vital Sign Monitoring and Follow-up Program for Hypertensive Disorders of Pregnancy (HDP) for 10 Days Postpartum

The literature unequivocally supports follow-up in the postpartum period post hospital discharge in hypertensive patients, compared to uncomplicated delivery follow-up recommendations of 4-6 weeks postpartum, leading to decreased morbidity and mortality, utilizing at-home blood pressure monitoring and virtual/telemedicine appointments. There is much evidence that telemedicine visits are equally, if not more effective, result in cost savings, and are generally preferred by patients, specifically when there is a risk of exposure for the patient and newborn, an appropriate factor to consider amidst the global Covid-19 pandemic. Maternal health and well-being have substantial links with cultural and racial factors. Black women are three times as likely to have morbid outcomes related to gestational complications, specifically hypertensive disorders of pregnancy. Minority populations have historically displayed inferior access to care due to concerns related to transportation, healthcare insurance, or provider accessibility and distrust, resulting in diminished compliance with follow-up and negative health sequelae.

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.

Study Overview

• Status: Completed
• Conditions: Preeclampsia; Hypertensive Disorder of Pregnancy; Gestational Hypertension
• Intervention / Treatment: Other: QI project- usage of RPM

Detailed Description

This QI project out of CSMC will create a formal remote patient follow-up and monitoring program utilizing the platform Vytrack as its' primary technology. Vytrack has the capability to sync with the EHR utilized by CSMC (C-S Link, an iteration of Epic), however this feature will not be utilized in establishing feasibility during this pilot project, due to cost prohibitions. Vytrack will provide participants with Bluetooth technology that automatically uploads in real-time and access to an application on participant's personal smartphone devices. Providers may choose to create emergency alerts within desired parameters for participant's uploaded vital signs via a provider portal.

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Leah M Spiro, FNP; Phone Number: 8185125456; Email: leahlousky@gmail.com
• Study Contact Backup: Name: Margo Minissian, PhD; Email: margo.minissian@cshs.org

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• postpartum hypertensive women
• 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:

• patients with eclampsia
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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.	Other: QI project- usage of RPM; close monitoring through RPM to analyze feasibility and compare readmission rates

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction with RPM compared with standard of care	Patient satisfaction with remote patient monitoring as measured by designed satisfaction surveys (not yet validated) after intervention. Survey is Likert style scale, each response is associated with a value	through 10 days postpartum
Adherence with the program	volume of patients that are compliant with providing study measurements- i.e submit vital signs in VyTrac application twice a day for enrollment period	ten days postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Readmission rate	postpartum readmission for hypertensive crises	through 6 weeks postpartum
Out of range blood pressures	blood pressures that are outside of the normal range (above 160/110)	through 10 days postpartum
titration of blood pressure medication	how many times antihypertensives needed to be titrated	within 10 days postpartum

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Collaborators: University of California, Los Angeles

Publications and helpful links

Helpful Links

• ACOG
• 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
• Hypertensive disorders of pregnancy, cesarean delivery, and severe maternal morbidity in an urban safety-net population. American Journal of Epi
• 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.
• SMFM special report: Putting the "M" back in MFM
• 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
• Hauspurg, A., Hubel, C.A., Michos, E.D., Ouyang, P., & Ying, W. (2018). Adverse pregnancy outcome and future maternal cardiovascular disease. Clinical Cardiology, 41(2), 239-246.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 7, 2022
• Primary Completion (ACTUAL): June 30, 2022
• Study Completion (ACTUAL): June 30, 2022

Study Registration Dates

• First Submitted: October 1, 2021
• First Submitted That Met QC Criteria: November 16, 2021
• First Posted (ACTUAL): November 17, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Telemedicine; Hypertension; Pregnancy; Remote monitoring; HDP; RPM
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Infections; Toxemia; Hypertension; Pre-Eclampsia; Pregnancy Complications; Hypertension, Pregnancy-Induced
• Other Study ID Numbers: STUDY00001570

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No