Remote Monitoring and Follow-up for Postpartum Hypertensive Disorders of Pregnancy
Primary Purpose
Hypertensive Disorder of Pregnancy, Preeclampsia, Gestational Hypertension
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
QI project- usage of RPM
Sponsored by
About this trial
This is an interventional prevention trial for Hypertensive Disorder of Pregnancy focused on measuring Remote monitoring, Hypertension, Pregnancy, HDP, RPM, Telemedicine
Eligibility Criteria
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.
Sites / Locations
- Cedars Sinai Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Intervention Group
Arm Description
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.
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Readmission rate
postpartum readmission for hypertensive crises
Out of range blood pressures
blood pressures that are outside of the normal range (above 160/110)
titration of blood pressure medication
how many times antihypertensives needed to be titrated
Full Information
NCT ID
NCT05124327
First Posted
October 1, 2021
Last Updated
February 6, 2023
Sponsor
Cedars-Sinai Medical Center
Collaborators
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT05124327
Brief Title
Remote Monitoring and Follow-up for Postpartum Hypertensive Disorders of Pregnancy
Official Title
Compliance and Satisfaction With a Remote Postpartum Vital Sign Monitoring and Follow-up Program for Hypertensive Disorders of Pregnancy (HDP) for 10 Days Postpartum
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 7, 2022 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center
Collaborators
University of California, Los Angeles
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
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertensive Disorder of Pregnancy, Preeclampsia, Gestational Hypertension
Keywords
Remote monitoring, Hypertension, Pregnancy, HDP, RPM, Telemedicine
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
QI project- usage of RPM
Intervention Description
close monitoring through RPM to analyze feasibility and compare readmission rates
Primary Outcome Measure Information:
Title
Patient satisfaction with RPM compared with standard of care
Description
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
Time Frame
through 10 days postpartum
Title
Adherence with the program
Description
volume of patients that are compliant with providing study measurements- i.e submit vital signs in VyTrac application twice a day for enrollment period
Time Frame
ten days postpartum
Secondary Outcome Measure Information:
Title
Readmission rate
Description
postpartum readmission for hypertensive crises
Time Frame
through 6 weeks postpartum
Title
Out of range blood pressures
Description
blood pressures that are outside of the normal range (above 160/110)
Time Frame
through 10 days postpartum
Title
titration of blood pressure medication
Description
how many times antihypertensives needed to be titrated
Time Frame
within 10 days postpartum
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
postpartum patients
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leah Spiro, FNP
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.acog.org/-/media/project/acog/acogorg/clinical/files/committee-opinion/articles/2018/05/optimizing-postpartum-care.pdf
Description
ACOG
URL
http://dx.doi.org/10.1186/s12884-021-03632-9
Description
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
URL
http://dx.doi.org/10.1097/AOG.0000000000003099
Description
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.
URL
http://dx.doi.org/10.1097/AOG.0000000000003479
Description
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.
URL
http://dx.doi.org/10.1515/jpm-2020-0337
Description
Early postpartum discharge during the COVID-19 pandemic. Journal of Perinatal Medicine, 48(9), 1008-101
URL
http://dx.doi.org/10.1093/aje/kwaa135
Description
Hypertensive disorders of pregnancy, cesarean delivery, and severe maternal morbidity in an urban safety-net population. American Journal of Epi
URL
http://dx.doi.org/10.1016/j.preghy.2016.04.005
Description
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.
URL
https://www.smfm.org/publications/259-smfm-special-report-putting-the-m-back-in-mfm-addressing-education-about-disparities-in-maternal-outcomes-and-care
Description
SMFM special report: Putting the "M" back in MFM
URL
https://pubmed.ncbi.nlm.nih.gov/30825917/
Description
Telehealth with remote blood pressure monitoring for postpartum hypertension: A prospective single-cohort feasibility study. Pregna
URL
https://pubmed.ncbi.nlm.nih.gov/28475431/
Description
Exploring implementation of m-health monitoring in postpartum women with hypertension. Telemedicine Journal and E-Health, 23(10), 8
URL
https://pubmed.ncbi.nlm.nih.gov/20618600/
Description
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.
URL
http://dx.doi.org/10.1097/HJH.0000000000001594
Description
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.
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Remote Monitoring and Follow-up for Postpartum Hypertensive Disorders of Pregnancy
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