Hypertensive Disorder of PregnancyNCT05124327
Remote Monitoring and Follow-up for Postpartum Hypertensive Disorders of Pregnancy
A study testing QI project- usage of RPM in people with Hypertensive Disorder of Pregnancy and Preeclampsia, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hypertensive Disorder of Pregnancy, Preeclampsia, Gestational Hypertension
- What is being tested?
- QI project- usage of RPM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2022to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars Sinai Medical Center
Los Angeles, California, 90048
About this study
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
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.
Read the 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.
- Being tested
- QI project- usage of RPM
- Keywords
- Remote monitoring, Hypertension, Pregnancy, HDP, RPM, Telemedicine
- Medical subject headings
- Toxemia, Pre-Eclampsia, Hypertension, Pregnancy-Induced, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QI project- usage of RPMOther
close monitoring through RPM to analyze feasibility and compare readmission rates
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: QI project- usage of RPM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: ten days postpartum
Secondary outcomes (3)
Readmission rate
postpartum readmission for hypertensive crises
Measured: through 6 weeks postpartum
Out of range blood pressures
blood pressures that are outside of the normal range (above 160/110)
Measured: through 10 days postpartum
titration of blood pressure medication
how many times antihypertensives needed to be titrated
Measured: within 10 days postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start7 Mar 2022
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertensive Disorder of PregnancyStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles
- Responsible party
- Principal investigator, Margo B. Minissian, Cedars-Sinai Medical Center
- Investigators
- Leah Spiro, FNP, Study director, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05124327
- Sponsor's protocol ID
- STUDY00001570
- Status last verified
- Feb 2023
- First submitted
- 1 Oct 2021
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05124327
- Acronym / sponsor ID
- STUDY00001570
- Keywords
- Remote monitoring, Hypertension, Pregnancy, HDP, RPM, Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- University of California, Los Angeles
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 17 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Other | Other: QI project- usage of RPMImplementation 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QI project- usage of RPMclose monitoring through RPM to analyze feasibility and compare readmission rates | Other | Intervention Group |
Primary outcome
Patient satisfaction with RPM compared with standard of care
Time frame: through 10 days postpartum
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
Time frame: ten days postpartum
volume of patients that are compliant with providing study measurements- i.e submit vital signs in VyTrac application twice a day for enrollment period
3 secondary outcomes
Readmission rate
Time frame: through 6 weeks postpartum
Out of range blood pressures
Time frame: through 10 days postpartum
titration of blood pressure medication
Time frame: within 10 days postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- ACOGLink provided by the sponsor.
- 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: 153Link provided by the sponsor.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Early postpartum discharge during the COVID-19 pandemic. Journal of Perinatal Medicine, 48(9), 1008-101Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leah Spiro, FNP study director
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QI project- usage of RPM in people with Hypertensive Disorder of Pregnancy and Preeclampsia, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction with RPM compared with standard of care (time frame: through 10 days postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.