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Remote BP Monitoring in the PP Period

Sponsor
Columbia University (Other)
Overall Status
Completed
CT.gov ID
NCT03728790
Collaborator
Philips Healthcare (Industry), New York Presbyterian Hospital (Other)
213
Enrollment
1
Location
2
Arms
18
Actual Duration (Months)
11.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Remote Patient Monitoring
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
213 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized Control Trial with 2 armsRandomized Control Trial with 2 arms
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
A Remote Postpartum (PP) Blood Pressure Surveillance and Reminder System for Hypertensive Disorders of Pregnancy: A Randomized Clinical Trial
Actual Study Start Date :
Nov 9, 2018
Actual Primary Completion Date :
Jul 28, 2019
Actual Study Completion Date :
May 11, 2020

Arms and Interventions

Arm Intervention/Treatment
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.

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.

Outcome Measures

Primary Outcome Measures

  1. Blood Pressure (BP) Surveillance Adherence [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

Secondary Outcome Measures

  1. Elevated Blood Pressure Percentage [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)

  2. Number of Participants With Outpatient BP Assessment Within 14 Days [Up to 14 days from delivery hospitalization discharge]

    Number of participants who had a documented outpatient BP assessment within 14 days of hospital discharge

  3. Incidence of BP Elevations [Up to 14 days from delivery hospitalization discharge]

    Incidence of elevated blood pressure at outpatient blood pressure assessment

  4. Number of Participants With Outpatient PP Assessment [Up to 8 weeks from delivery]

    Number of participants who had an outpatient postpartum (PP) assessment

  5. Incidence of BP Elevations [Up to 8 weeks from delivery]

    Incidence of elevated blood pressure (BP) at the postpartum visit

  6. Time to Medication Initiation [Up to 8 weeks from delivery]

    Time to initiation of antihypertensive medications (in patients who were not on medications at time of discharge)

  7. Number of Participants Initiated on Antihypertensive Therapy After Hospital Discharge [Up to 8 weeks from delivery]

    Number of participants discharged from delivery hospitalization without antihypertensive therapy, who were subsequently started on antihypertensive therapy

  8. Number of Participants Readmitted [Up to 8 weeks from delivery]

    Number of participants who were readmitted after delivery hospitalization discharge

  9. Number of Participants With ED Visit [Up to 8 weeks from delivery]

    Number of participants who had an Emergency Department (ED) visit after delivery hospitalization discharge

  10. Number of Participants Who Developed Preeclampsia-associated Complications [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.

  11. Number of Participants Referred to Primary Care for Continued Blood Pressure Management [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

  12. Score on the Modified Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ) [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.

  13. Change in Score on the Philips Program Survey [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.

  14. Communications [Up to 14 days post delivery hospitalization discharge]

    Elevated blood pressures that led to communication with an obstetric provider

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Columbia University Medical Center New York New York United States 10032

Sponsors and Collaborators

  • Columbia University
  • Philips Healthcare
  • New York Presbyterian Hospital

Investigators

  • Principal Investigator: Leslie Moroz, MD, Columbia University

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Leslie Moroz, Assistant Professor of Obstetrics & Gynecology, Columbia University
ClinicalTrials.gov Identifier:
NCT03728790
Other Study ID Numbers:
  • AAAS0065
First Posted:
Nov 2, 2018
Last Update Posted:
Sep 28, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Leslie Moroz, Assistant Professor of Obstetrics & Gynecology, Columbia University
hypertensive disorders of pregnancy
preeclampsia
gestational hypertension
HELLP
Additional relevant MeSH terms:
Toxemia
Pregnancy Complications
Pre-Eclampsia
Hypertension

Study Results

Participant Flow

Recruitment Details Subjects were recruited from the inpatient postpartum service after delivery. Recruitment began on November 9, 2018. The last participant was recruited on July 10, 2019.
Pre-assignment Detail 426 women with hypertension were assessed for eligibility. 123 women were excluded: 1 was under 18 years old, 49 resided outside of New York State, 22 received care at a non-participating office, 48 were planning on following up at another institution, 2 spoke a language other than English or Spanish and 1 was unable to use the tablet. 90 declined.
Arm/Group Title Usual Care Remote Patient Monitoring
Arm/Group 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. 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.
Period Title: Overall Study
STARTED 112 101
COMPLETED 112 101
NOT COMPLETED 0 0

Baseline Characteristics

Arm/Group Title Usual Care Remote Patient Monitoring Total
Arm/Group 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. 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. Total of all reporting groups
Overall Participants 112 101 213
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]
32
33
33
Sex: Female, Male (Count of Participants)
Female
112
100%
101
100%
213
100%
Male
0
0%
0
0%
0
0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
67
59.8%
53
52.5%
120
56.3%
Not Hispanic or Latino
45
40.2%
48
47.5%
93
43.7%
Unknown or Not Reported
0
0%
0
0%
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
Asian
11
9.8%
5
5%
16
7.5%
Native Hawaiian or Other Pacific Islander
1
0.9%
0
0%
1
0.5%
Black or African American
32
28.6%
32
31.7%
64
30%
White
48
42.9%
55
54.5%
103
48.4%
More than one race
1
0.9%
0
0%
1
0.5%
Unknown or Not Reported
19
17%
9
8.9%
28
13.1%
Multiparous (Count of Participants)
Count of Participants [Participants]
81
72.3%
83
82.2%
164
77%
Married/Partnered (participants) [Number]
Number [participants]
76
67.9%
89
88.1%
165
77.5%
Highest level of education (Count of Participants)
Graduate School
35
31.3%
26
25.7%
61
28.6%
College
25
22.3%
26
25.7%
51
23.9%
Some college
16
14.3%
18
17.8%
34
16%
High school
26
23.2%
27
26.7%
53
24.9%
Some high school
6
5.4%
3
3%
9
4.2%
Elementary school
1
0.9%
1
1%
2
0.9%
Declined to answer
3
2.7%
0
0%
3
1.4%
Employment status (Count of Participants)
Employed
75
67%
66
65.3%
141
66.2%
Unemployed
33
29.5%
30
29.7%
63
29.6%
Self-employed
4
3.6%
5
5%
9
4.2%
Type of insurance (Count of Participants)
Public Insurance
47
42%
41
40.6%
88
41.3%
Private Insurance
65
58%
60
59.4%
125
58.7%
Born outside of United States (Count of Participants)
Count of Participants [Participants]
54
48.2%
49
48.5%
103
48.4%
Religion (Count of Participants)
Christian
57
50.9%
55
54.5%
112
52.6%
Jewish
4
3.6%
7
6.9%
11
5.2%
Muslim
4
3.6%
2
2%
6
2.8%
Jehovah's Witness
3
2.7%
0
0%
3
1.4%
Hindu
0
0%
2
2%
2
0.9%
None
37
33%
34
33.7%
71
33.3%
Other
7
6.3%
1
1%
8
3.8%
Type of prenatal care (Count of Participants)
Generalist
62
55.4%
55
54.5%
117
54.9%
Maternal fetal medicine (MFM)
45
40.2%
43
42.6%
88
41.3%
No prenatal care
5
4.5%
3
3%
8
3.8%
Smoking status (Count of Participants)
Current Smokers
0
0%
1
1%
1
0.5%
Former Smokers
6
5.4%
5
5%
11
5.2%
Drug use status (Count of Participants)
Current users
0
0%
1
1%
1
0.5%
Former users
6
5.4%
1
1%
7
3.3%
Time of initiation of prenatal care (Count of Participants)
First trimester
84
75%
82
81.2%
166
77.9%
Second trimester
24
21.4%
15
14.9%
39
18.3%
Third trimester
1
0.9%
2
2%
3
1.4%
Unknown
3
2.7%
1
1%
4
1.9%
No prenatal care
0
0%
1
1%
1
0.5%
Diabetes diagnosis (Count of Participants)
Type 1 Diabetes
1
0.9%
0
0%
1
0.5%
Type 2 Diabetes
4
3.6%
1
1%
5
2.3%
Gestational diabetes, diet controlled
5
4.5%
8
7.9%
13
6.1%
Gestational diabetes, oral agents
1
0.9%
4
4%
5
2.3%
Gestational diabetes, insulin
7
6.3%
3
3%
10
4.7%
Gestational age at delivery (Count of Participants)
20-23 6/7 weeks
0
0%
1
1%
1
0.5%
24-27 6/7 weeks
3
2.7%
1
1%
4
1.9%
28-33 6/7 weeks
12
10.7%
8
7.9%
20
9.4%
34-36 6/7 weeks
16
14.3%
20
19.8%
36
16.9%
37-38 6/7 weeks
52
46.4%
42
41.6%
94
44.1%
39-40 6/7 weeks
26
23.2%
29
28.7%
55
25.8%
>41 weeks
3
2.7%
0
0%
3
1.4%
Type of delivery (Count of Participants)
Cesarean Delivery
56
50%
57
56.4%
113
53.1%
Spontaneous Vaginal Delivery
53
47.3%
43
42.6%
96
45.1%
Forceps-assisted Vaginal Delivery
3
2.7%
1
1%
4
1.9%
Neonatal disposition (Count of Participants)
Fetal Demise
1
0.9%
0
0%
1
0.5%
Neonatal Demise
1
0.9%
0
0%
1
0.5%
Neonatal intensive care unit (NICU) admission
28
25%
19
18.8%
47
22.1%
Type of hypertension (Count of Participants)
Chronic Hypertension
14
12.5%
15
14.9%
29
13.6%
Superimposed preeclampsia
12
10.7%
9
8.9%
21
9.9%
Gestational Hypertension
38
33.9%
33
32.7%
71
33.3%
Preeclampsia without severe features
12
10.7%
17
16.8%
29
13.6%
Preeclampsia with severe features/HELLP Syndrome
36
32.1%
26
25.7%
62
29.1%
Eclampsia
0
0%
1
1%
1
0.5%
Exposure to magnesium sulfate (Count of Participants)
Count of Participants [Participants]
44
39.3%
34
33.7%
78
36.6%
Urgent antihypertensive medication antepartum or intrapartum (Count of Participants)
Count of Participants [Participants]
21
18.8%
15
14.9%
36
16.9%
Discharged on antihypertensive medication (Count of Participants)
Count of Participants [Participants]
47
42%
41
40.6%
88
41.3%

Outcome Measures

1. Primary Outcome
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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Remote Patient Monitoring
Arm/Group 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. 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.
Measure Participants 112 101
Median (Full Range) [percentage of recommended BPs reported]
0.0
61.1
2. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
3. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Remote Patient Monitoring
Arm/Group 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. 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.
Measure Participants 112 101
Count of Participants [Participants]
69
61.6%
59
58.4%
4. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
5. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Remote Patient Monitoring
Arm/Group 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. 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.
Measure Participants 112 101
Count of Participants [Participants]
88
78.6%
82
81.2%
6. Secondary Outcome
Title Incidence of BP Elevations
Description Incidence of elevated blood pressure (BP) at the postpartum visit
Time Frame Up to 8 weeks from delivery

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
7. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
The analyzed population only includes participants in each arm who were not on medications at the time of discharge.
Arm/Group Title Usual Care Remote Patient Monitoring
Arm/Group 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. 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.
Measure Participants 65 60
Median (Inter-Quartile Range) [days]
6.5
6.0
8. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Remote Patient Monitoring
Arm/Group 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. 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.
Measure Participants 65 60
Count of Participants [Participants]
10
8.9%
24
23.8%
9. Secondary Outcome
Title Number of Participants Readmitted
Description Number of participants who were readmitted after delivery hospitalization discharge
Time Frame Up to 8 weeks from delivery

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Remote Patient Monitoring
Arm/Group 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. 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.
Measure Participants 112 101
Count of Participants [Participants]
7
6.3%
13
12.9%
10. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Remote Patient Monitoring
Arm/Group 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. 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.
Measure Participants 112 101
Count of Participants [Participants]
17
15.2%
25
24.8%
11. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Remote Patient Monitoring
Arm/Group 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. 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.
Measure Participants 112 101
Count of Participants [Participants]
4
3.6%
9
8.9%
12. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Remote Patient Monitoring
Arm/Group 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. 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.
Measure Participants 112 101
Count of Participants [Participants]
31
27.7%
38
37.6%
13. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
14. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
15. Secondary Outcome
Title Communications
Description Elevated blood pressures that led to communication with an obstetric provider
Time Frame Up to 14 days post delivery hospitalization discharge

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description

Adverse Events

Time Frame Adverse event data were collected through the end of the study period, which ended at the time of participants' postpartum visit or 8 weeks postpartum, whichever came first.
Adverse Event Reporting Description
Arm/Group Title Usual Care Remote Patient Monitoring
Arm/Group 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. 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.
All Cause Mortality
Usual Care Remote Patient Monitoring
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/112 (0%) 0/101 (0%)
Serious Adverse Events
Usual Care Remote Patient Monitoring
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 7/112 (6.3%) 13/101 (12.9%)
Pregnancy, puerperium and perinatal conditions
Readmission 7/112 (6.3%) 7 13/101 (12.9%) 13
Other (Not Including Serious) Adverse Events
Usual Care Remote Patient Monitoring
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/112 (0%) 0/101 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Dr. Leslie Moroz
Organization Columbia University
Phone 646-532-8208
Email lm3000@cumc.columbia.edu
Responsible Party:
Leslie Moroz, Assistant Professor of Obstetrics & Gynecology, Columbia University
ClinicalTrials.gov Identifier:
NCT03728790
Other Study ID Numbers:
  • AAAS0065
First Posted:
Nov 2, 2018
Last Update Posted:
Sep 28, 2020
Last Verified:
Sep 1, 2020