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

NCT05124327 | Completed

• 1 other identifier: STUDY00001570
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertensive Disorder of Pregnancy; Preeclampsia; Gestational Hypertension

Keywords

Remote monitoring; Hypertension; Pregnancy; HDP; RPM; Telemedicine

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Readmission rate

  through 6 weeks postpartum

• Out of range blood pressures

  through 10 days postpartum

• titration of blood pressure medication

  within 10 days postpartum

Study Arms (1)

Intervention Group

OTHER

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

Interventions

QI project- usage of RPM OTHER

close monitoring through RPM to analyze feasibility and compare readmission rates

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: postpartum patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• University of California, Los Angeles: collaborator

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related 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
• 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.

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

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

Study Officials

• Leah Spiro, FNP

  Cedars-Sinai Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: November 17, 2021
• Study Start: March 7, 2022
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)