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Remote BP Monitoring in the PP Period

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ClinicalTrials.gov Identifier: NCT03728790
Recruitment Status : Completed
First Posted : November 2, 2018
Results First Posted : September 28, 2020
Last Update Posted : September 28, 2020
Sponsor:
Collaborators:
Philips Healthcare
New York Presbyterian Hospital
Information provided by (Responsible Party):
Leslie Moroz, Columbia University

Tracking Information
First Submitted Date  ICMJE October 28, 2018
First Posted Date  ICMJE November 2, 2018
Results First Submitted Date  ICMJE July 24, 2020
Results First Posted Date  ICMJE September 28, 2020
Last Update Posted Date September 28, 2020
Actual Study Start Date  ICMJE November 9, 2018
Actual Primary Completion Date July 28, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2020)
Blood Pressure (BP) Surveillance Adherence [ Time Frame: Up to 14 days from delivery hospitalization discharge ]
Percentage of recommended twice-daily blood pressures reported between hospital discharge and first outpatient blood pressure assessment
Original Primary Outcome Measures  ICMJE
 (submitted: October 31, 2018)
Blood Pressure Measurement Percentage [ Time Frame: Up to 10 days from delivery ]
Percentage of the recommended twice daily blood pressures recorded between hospital discharge and the 7-10 day postpartum blood pressure check in-person visit.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2020)
  • Elevated Blood Pressure Percentage [ Time Frame: Up to 14 days from delivery hospitalization discharge ]
    Percentage of recorded blood pressure values at first outpatient blood pressure assessment that are elevated (>140 systolic or >90 diastolic)
  • Number of Participants With Outpatient BP Assessment Within 14 Days [ Time Frame: Up to 14 days from delivery hospitalization discharge ]
    Number of participants who had a documented outpatient BP assessment within 14 days of hospital discharge
  • Incidence of BP Elevations [ Time Frame: Up to 14 days from delivery hospitalization discharge ]
    Incidence of elevated blood pressure at outpatient blood pressure assessment
  • Number of Participants With Outpatient PP Assessment [ Time Frame: Up to 8 weeks from delivery ]
    Number of participants who had an outpatient postpartum (PP) assessment
  • Incidence of BP Elevations [ Time Frame: Up to 8 weeks from delivery ]
    Incidence of elevated blood pressure (BP) at the postpartum visit
  • Time to Medication Initiation [ Time Frame: Up to 8 weeks from delivery ]
    Time to initiation of antihypertensive medications (in patients who were not on medications at time of discharge)
  • Number of Participants Initiated on Antihypertensive Therapy After Hospital Discharge [ Time Frame: Up to 8 weeks from delivery ]
    Number of participants discharged from delivery hospitalization without antihypertensive therapy, who were subsequently started on antihypertensive therapy
  • Number of Participants Readmitted [ Time Frame: Up to 8 weeks from delivery ]
    Number of participants who were readmitted after delivery hospitalization discharge
  • Number of Participants With ED Visit [ Time Frame: Up to 8 weeks from delivery ]
    Number of participants who had an Emergency Department (ED) visit after delivery hospitalization discharge
  • Number of Participants Who Developed Preeclampsia-associated Complications [ Time Frame: Up to 8 weeks from delivery ]
    Number of patients who experienced preeclampsia-related morbidity (eg: stroke, seizure, posterior reversible encephalopathy syndrome (PRES) , pulmonary edema, liver function abnormality, reversible cerebral vasoconstriction syndrome (RCVS) , renal insufficiency, thrombocytopenia) after delivery hospitalization discharge.
  • Number of Participants Referred to Primary Care for Continued Blood Pressure Management [ Time Frame: Up to 8 weeks from delivery ]
    Number of participants who require a referral to primary care physicians for continued blood pressure management after being discharged from obstetric care at the postpartum visit
  • Score on the Modified Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ) [ Time Frame: Up to 8 weeks from delivery ]
    The modified TSUQ is an 18-item survey that will be used to measure patient satisfaction with remote blood pressure monitoring. Individuals score each of the items based on their satisfaction, with 1=strongly disagree to 5=strongly agree. The responses would then be used to calculate a mean score on the 5-point scale, with 5 indicating the most satisfaction.
  • Change in Score on the Philips Program Survey [ Time Frame: Up to 8 weeks from delivery ]
    The Philips program start survey is a 4 question survey to gauge how patients relate to their care and their doctors prior to initiation of their blood pressure monitoring program. Individuals score each of the items based on the perception of their care, with 5 being best and 1 being worst. The responses would then be used to calculate a mean score on the 5-point scale, with 5 indicating the most satisfaction, and compared between the 2 groups. The Philips program end survey is a 6 question survey to gauge how patients related to their care and their doctors after the completion of their blood pressure monitoring program. Individuals score each of the items based on the perception of their care, with 5 being best and 1 being worst. The responses would then be used to calculate a mean score on the 5-point scale, with 5 indicating the most satisfaction, and compared between the 2 groups.
  • Communications [ Time Frame: Up to 14 days post delivery hospitalization discharge ]
    Elevated blood pressures that led to communication with an obstetric provider
Original Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2018)
  • Elevated Blood Pressure Percentage [ Time Frame: Up to 10 days from delivery ]
    Percentage of recorded blood pressure values in 7-10 days postpartum that are elevated (>140 systolic OR >90 diastolic)
  • Percentage of Elevated Blood Pressure Leading to Conversation between Patient and Provider [ Time Frame: Up to 10 days from delivery ]
    Percentage of elevated blood pressures that triggered a phone call or conversation with an obstetric provider
  • Visit Compliance Rate [ Time Frame: Up to 10 days from delivery ]
    Rate of attendance at 7-10 day blood pressure check visit
  • Incidence of BP Elevations [ Time Frame: Up to 10 days from delivery ]
    Incidence of elevated blood pressure at the 7-10 day blood pressure check visit
  • Visit Compliance Rate [ Time Frame: 6 weeks from delivery ]
    Rate of attendance at 6 week postpartum visit
  • Incidence of BP Elevations [ Time Frame: 6 weeks from delivery ]
    Incidence of elevated blood pressure (BP) at the 6-week postpartum visit
  • Time to Medication Initiation [ Time Frame: 6 weeks from delivery ]
    Time to initiation of antihypertensive medications (in patients who were not on medications at time of discharge)
  • Final Antihypertensive Dosage [ Time Frame: 6 weeks from delivery ]
    Final dosage of antihypertensive medications at 6 weeks postpartum
  • Readmission Rate [ Time Frame: 6 weeks from delivery ]
    Rate of readmission in the postpartum period
  • ED Visit Rate [ Time Frame: 6 weeks from delivery ]
    Rate of emergency department (ED) visits
  • Rate of Morbidity [ Time Frame: 6 weeks from delivery ]
    Incidence of hypertension-related morbidities (eg: stroke, seizure, PRES)
  • Percentage With Primary Care Referrals [ Time Frame: 6 weeks from delivery ]
    Percentage of patients who require a referral to primary care physicians after being discharged from obstetric care at the 6-week postpartum visit
  • Score on the Modified Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ) [ Time Frame: 6 weeks from delivery ]
    The modified TSUQ is an 18-item survey that will be used to measure patient satisfaction with remote blood pressure monitoring. Individuals score each of the items based on their satisfaction, with 1=strongly disagree to 5=strongly agree. The responses would then be used to calculate a mean score on the 5-point scale, with 5 indicating the most satisfaction.
  • Change in Score on the Philips Program Survey [ Time Frame: 6 weeks from delivery ]
    The Philips program start survey is a 4 question survey to gauge how patients relate to their care and their doctors prior to initiation of their blood pressure monitoring program. Individuals score each of the items based on the perception of their care, with 5 being best and 1 being worst. The responses would then be used to calculate a mean score on the 5-point scale, with 5 indicating the most satisfaction, and compared between the 2 groups. The Philips program end survey is a 6 question survey to gauge how patients related to their care and their doctors after the completion of their blood pressure monitoring program. Individuals score each of the items based on the perception of their care, with 5 being best and 1 being worst. The responses would then be used to calculate a mean score on the 5-point scale, with 5 indicating the most satisfaction, and compared between the 2 groups.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Remote BP Monitoring in the PP Period
Official Title  ICMJE A Remote Postpartum (PP) Blood Pressure Surveillance and Reminder System for Hypertensive Disorders of Pregnancy: A Randomized Clinical Trial
Brief Summary The purpose of this study is to trial remote patient monitoring (RPM) in the postpartum hypertensive population in a randomized control design, with an aim to increase the number of blood pressure measurements taken during the fragile and under-monitored postpartum period and to thereby improve postpartum blood pressure control and reduce severe morbidity and mortality. The investigators plan to compare the number of blood pressures recorded in the first 10 days postpartum between patients who have been enrolled in an RPM trial to those who are being treated with the usual care.
Detailed Description Many women develop high blood pressure as a complication of pregnancy. This high blood pressure can often take many weeks to resolve, and for some women it never resolves completely. If untreated, high blood pressure of pregnancy can lead to serious consequences, such as seizure or stroke. Unfortunately, because most women are sent home from the hospital just 2-3 days after having a baby, the best way of monitoring blood pressure at home is still unknown. Most women are given a prescription for a blood pressure cuff to use at home and an appointment to see their doctor at about one week after delivery to review their blood pressures, but many women have trouble checking their blood pressures, sometimes because they have a new baby at home and sometimes for other reasons like transportation or difficult social situations. Using a Bluetooth blood pressure monitoring system might help women have better blood pressure monitoring after they are discharged from the hospital after delivery, and therefore help to prevent some of the complications that can happen because of high blood pressure related to pregnancy.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized Control Trial with 2 arms
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Hypertensive Disorder of Pregnancy
Intervention  ICMJE Device: Remote Patient Monitoring
Bluetooth-enabled blood pressure cuff to assess whether this technology helps providers collect more data regarding their patients' blood pressures in the postpartum period.
Study Arms  ICMJE
  • No Intervention: Usual Care
    Usual care group patients will be assigned to the usual care given to patients with hypertensive disorders of pregnancy at Columbia University Irving Medical Center (CUIMC). This involves a prescription for a blood pressure cuff if they do not already have one, with which they will be asked to measure their blood pressure twice per day. They will be asked to keep a log of their blood pressure measurements and to bring that log to their next provider visit.
  • Experimental: Remote Patient Monitoring
    Remote Patient Monitoring patients will use a Bluetooth-enabled blood pressure cuff, which will transmit blood pressure measurements via Bluetooth from the monitor to a tablet, which is able to be accessed by nurses staffing a remote clinical care center. Patients will also be prompted to answer surveys assessing symptoms of preeclampsia. The nurses will review measurements and survey results, which will be flagged in order of urgency. The measurements uploaded into the remote monitoring system will also be reviewed at the patient's next provider visit.
    Intervention: Device: Remote Patient Monitoring
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 5, 2019)
213
Original Estimated Enrollment  ICMJE
 (submitted: October 31, 2018)
202
Actual Study Completion Date  ICMJE May 11, 2020
Actual Primary Completion Date July 28, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Postpartum women
  • Previous diagnosis of chronic hypertension, or antepartum diagnosis of hypertensive disorder of pregnancy (defined as documented blood pressure of ≥140 systolic or ≥90 diastolic on at least 2 occasions at least 4 hours apart)
  • At least 18 years of age
  • English or Spanish speakers

Exclusion Criteria:

  • Non-English or Spanish speakers
  • Women who are not planning on obtaining their postpartum follow up at CUIMC
  • Women who are physically unable to hold or use the tablet
  • Women who do not have a working phone
  • Provider unwilling or unable to set up escalation pathway
  • Women who reside outside of New York State
  • Hypertension diagnosed postpartum
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03728790
Other Study ID Numbers  ICMJE AAAS0065
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Leslie Moroz, Columbia University
Study Sponsor  ICMJE Columbia University
Collaborators  ICMJE
  • Philips Healthcare
  • New York Presbyterian Hospital
Investigators  ICMJE
Principal Investigator: Leslie Moroz, MD Columbia University
PRS Account Columbia University
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP