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Remote BP Monitoring in the PP Period

Primary Purpose

Hypertensive Disorder of Pregnancy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Remote Patient Monitoring
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypertensive Disorder of Pregnancy focused on measuring hypertensive disorders of pregnancy, preeclampsia, gestational hypertension, HELLP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Columbia University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

Remote Patient Monitoring

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Blood Pressure (BP) Surveillance Adherence
Percentage of recommended twice-daily blood pressures reported between hospital discharge and first outpatient blood pressure assessment

Secondary Outcome Measures

Elevated Blood Pressure Percentage
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
Number of participants who had a documented outpatient BP assessment within 14 days of hospital discharge
Incidence of BP Elevations
Incidence of elevated blood pressure at outpatient blood pressure assessment
Number of Participants With Outpatient PP Assessment
Number of participants who had an outpatient postpartum (PP) assessment
Incidence of BP Elevations
Incidence of elevated blood pressure (BP) at the postpartum visit
Time to Medication Initiation
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
Number of participants discharged from delivery hospitalization without antihypertensive therapy, who were subsequently started on antihypertensive therapy
Number of Participants Readmitted
Number of participants who were readmitted after delivery hospitalization discharge
Number of Participants With ED Visit
Number of participants who had an Emergency Department (ED) visit after delivery hospitalization discharge
Number of Participants Who Developed Preeclampsia-associated Complications
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
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)
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
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
Elevated blood pressures that led to communication with an obstetric provider

Full Information

First Posted
October 28, 2018
Last Updated
September 5, 2020
Sponsor
Columbia University
Collaborators
Philips Healthcare, New York Presbyterian Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03728790
Brief Title
Remote BP Monitoring in the PP Period
Official Title
A Remote Postpartum (PP) Blood Pressure Surveillance and Reminder System for Hypertensive Disorders of Pregnancy: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
November 9, 2018 (Actual)
Primary Completion Date
July 28, 2019 (Actual)
Study Completion Date
May 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
Philips Healthcare, New York Presbyterian Hospital

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertensive Disorder of Pregnancy
Keywords
hypertensive disorders of pregnancy, preeclampsia, gestational hypertension, HELLP

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Control Trial with 2 arms
Masking
None (Open Label)
Allocation
Randomized
Enrollment
213 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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.
Arm Title
Remote Patient Monitoring
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
Remote Patient Monitoring
Intervention Description
Bluetooth-enabled blood pressure cuff to assess whether this technology helps providers collect more data regarding their patients' blood pressures in the postpartum period.
Primary Outcome Measure Information:
Title
Blood Pressure (BP) Surveillance Adherence
Description
Percentage of recommended twice-daily blood pressures reported between hospital discharge and first outpatient blood pressure assessment
Time Frame
Up to 14 days from delivery hospitalization discharge
Secondary Outcome Measure Information:
Title
Elevated Blood Pressure Percentage
Description
Percentage of recorded blood pressure values at first outpatient blood pressure assessment that are elevated (>140 systolic or >90 diastolic)
Time Frame
Up to 14 days from delivery hospitalization discharge
Title
Number of Participants With Outpatient BP Assessment Within 14 Days
Description
Number of participants who had a documented outpatient BP assessment within 14 days of hospital discharge
Time Frame
Up to 14 days from delivery hospitalization discharge
Title
Incidence of BP Elevations
Description
Incidence of elevated blood pressure at outpatient blood pressure assessment
Time Frame
Up to 14 days from delivery hospitalization discharge
Title
Number of Participants With Outpatient PP Assessment
Description
Number of participants who had an outpatient postpartum (PP) assessment
Time Frame
Up to 8 weeks from delivery
Title
Incidence of BP Elevations
Description
Incidence of elevated blood pressure (BP) at the postpartum visit
Time Frame
Up to 8 weeks from delivery
Title
Time to Medication Initiation
Description
Time to initiation of antihypertensive medications (in patients who were not on medications at time of discharge)
Time Frame
Up to 8 weeks from delivery
Title
Number of Participants Initiated on Antihypertensive Therapy After Hospital Discharge
Description
Number of participants discharged from delivery hospitalization without antihypertensive therapy, who were subsequently started on antihypertensive therapy
Time Frame
Up to 8 weeks from delivery
Title
Number of Participants Readmitted
Description
Number of participants who were readmitted after delivery hospitalization discharge
Time Frame
Up to 8 weeks from delivery
Title
Number of Participants With ED Visit
Description
Number of participants who had an Emergency Department (ED) visit after delivery hospitalization discharge
Time Frame
Up to 8 weeks from delivery
Title
Number of Participants Who Developed Preeclampsia-associated Complications
Description
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.
Time Frame
Up to 8 weeks from delivery
Title
Number of Participants Referred to Primary Care for Continued Blood Pressure Management
Description
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
Time Frame
Up to 8 weeks from delivery
Title
Score on the Modified Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ)
Description
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.
Time Frame
Up to 8 weeks from delivery
Title
Change in Score on the Philips Program Survey
Description
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.
Time Frame
Up to 8 weeks from delivery
Title
Communications
Description
Elevated blood pressures that led to communication with an obstetric provider
Time Frame
Up to 14 days post delivery hospitalization discharge

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leslie Moroz, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Remote BP Monitoring in the PP Period

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