Trial Outcomes & Findings for Remote BP Monitoring in the PP Period (NCT NCT03728790)
NCT ID: NCT03728790
Last Updated: 2025-01-01
Results Overview
Percentage of recommended twice-daily blood pressures reported between hospital discharge and first outpatient blood pressure assessment
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
213 participants
Primary outcome timeframe
Up to 14 days from delivery hospitalization discharge
Results posted on
2025-01-01
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
112
|
101
|
|
Overall Study
COMPLETED
|
112
|
101
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Remote BP Monitoring in the PP Period
Baseline characteristics by cohort
| Measure |
Usual Care
n=112 Participants
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
n=101 Participants
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
n=213 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32 years
n=5 Participants
|
33 years
n=7 Participants
|
33 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
112 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
213 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
67 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
32 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
19 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Multiparous
|
81 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
|
Married/Partnered
|
76 participants
n=5 Participants
|
89 participants
n=7 Participants
|
165 participants
n=5 Participants
|
|
Highest level of education
Graduate School
|
35 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Highest level of education
College
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Highest level of education
Some college
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Highest level of education
High school
|
26 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Highest level of education
Some high school
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Highest level of education
Elementary school
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Highest level of education
Declined to answer
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Employment status
Employed
|
75 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
|
Employment status
Unemployed
|
33 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Employment status
Self-employed
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Type of insurance
Public Insurance
|
47 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Type of insurance
Private Insurance
|
65 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Born outside of United States
|
54 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Religion
Christian
|
57 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Religion
Jewish
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Religion
Muslim
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Religion
Jehovah's Witness
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Religion
Hindu
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Religion
None
|
37 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Religion
Other
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Type of prenatal care
Generalist
|
62 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Type of prenatal care
Maternal fetal medicine (MFM)
|
45 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Type of prenatal care
No prenatal care
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Smoking status
Current Smokers
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Smoking status
Former Smokers
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Drug use status
Current users
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Drug use status
Former users
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Time of initiation of prenatal care
First trimester
|
84 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
166 Participants
n=5 Participants
|
|
Time of initiation of prenatal care
Second trimester
|
24 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Time of initiation of prenatal care
Third trimester
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Time of initiation of prenatal care
Unknown
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Time of initiation of prenatal care
No prenatal care
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Diabetes diagnosis
Type 1 Diabetes
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Diabetes diagnosis
Type 2 Diabetes
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Diabetes diagnosis
Gestational diabetes, diet controlled
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Diabetes diagnosis
Gestational diabetes, oral agents
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Diabetes diagnosis
Gestational diabetes, insulin
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Gestational age at delivery
20-23 6/7 weeks
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Gestational age at delivery
24-27 6/7 weeks
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Gestational age at delivery
28-33 6/7 weeks
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Gestational age at delivery
34-36 6/7 weeks
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Gestational age at delivery
37-38 6/7 weeks
|
52 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Gestational age at delivery
39-40 6/7 weeks
|
26 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Gestational age at delivery
>41 weeks
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Type of delivery
Cesarean Delivery
|
56 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Type of delivery
Spontaneous Vaginal Delivery
|
53 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Type of delivery
Forceps-assisted Vaginal Delivery
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Neonatal disposition
Fetal Demise
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Neonatal disposition
Neonatal Demise
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Neonatal disposition
Neonatal intensive care unit (NICU) admission
|
28 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Type of hypertension
Chronic Hypertension
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Type of hypertension
Superimposed preeclampsia
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Type of hypertension
Gestational Hypertension
|
38 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Type of hypertension
Preeclampsia without severe features
|
12 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Type of hypertension
Preeclampsia with severe features/HELLP Syndrome
|
36 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Type of hypertension
Eclampsia
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Exposure to magnesium sulfate
|
44 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Urgent antihypertensive medication antepartum or intrapartum
|
21 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Discharged on antihypertensive medication
|
47 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 14 days from delivery hospitalization dischargePercentage of recommended twice-daily blood pressures reported between hospital discharge and first outpatient blood pressure assessment
Outcome measures
| Measure |
Usual Care
n=112 Participants
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
n=101 Participants
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.
|
|---|---|---|
|
Blood Pressure (BP) Surveillance Adherence
|
0.0 percentage of recommended BPs reported
Interval 0.0 to 100.0
|
61.1 percentage of recommended BPs reported
Interval 0.0 to 92.3
|
SECONDARY outcome
Timeframe: Up to 14 days from delivery hospitalization dischargePopulation: The analyzed population only includes participants who recorded at least one blood pressure at home after hospital discharge.
Of all blood pressure (BP) recordings collected per arm, the total percentage of those that were elevated will be reported. Elevated blood pressure defined as \>/=140 systolic or \>/=90 diastolic) by time of first outpatient blood pressure assessment (or 14 days from discharge, whichever came first).
Outcome measures
| Measure |
Usual Care
n=31 Participants
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
n=89 Participants
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 Percentage of Elevated Blood Pressure Readings
|
37.52 percentage of elevated BP readings
|
49.6 percentage of elevated BP readings
|
SECONDARY outcome
Timeframe: Up to 14 days from delivery hospitalization dischargeNumber of participants who had a documented outpatient BP assessment within 14 days of hospital discharge (excluding measurements taken at home)
Outcome measures
| Measure |
Usual Care
n=112 Participants
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
n=101 Participants
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.
|
|---|---|---|
|
Number of Participants With Outpatient BP Assessment Within 14 Days
|
69 Participants
|
59 Participants
|
SECONDARY outcome
Timeframe: Up to 14 days from delivery hospitalization dischargePopulation: 1 participant in the Usual Care group attended but did not have BP recorded at outpatient visit. 2 participants in the Remote Patient Monitoring group attended but did not have BP recorded at outpatient visit.
Incidence of elevated blood pressure (\>140 systolic or \>90 diastolic) at outpatient blood pressure assessment
Outcome measures
| Measure |
Usual Care
n=68 Participants
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
n=57 Participants
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.
|
|---|---|---|
|
Percentage of Participants With Elevated BP After Discharge
|
27.9 percentage of participants
|
24.5 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 8 weeks from deliveryNumber of participants who had an outpatient postpartum (PP) assessment
Outcome measures
| Measure |
Usual Care
n=112 Participants
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
n=101 Participants
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.
|
|---|---|---|
|
Number of Participants With Outpatient PP Assessment
|
88 Participants
|
82 Participants
|
SECONDARY outcome
Timeframe: Up to 8 weeks from deliveryPopulation: The analyzed population only includes participants who had an outpatient postpartum assessment.
Incidence of elevated blood pressure (\>140 systolic or \>90 diastolic) at the postpartum visit
Outcome measures
| Measure |
Usual Care
n=88 Participants
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
n=82 Participants
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.
|
|---|---|---|
|
Percentage of Participants With Elevated Blood Pressure at the Postpartum Visit
|
13.6 percentage of participants
|
17.1 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 8 weeks from deliveryPopulation: The analyzed population only includes participants in each arm who were not on medications at the time of discharge.
Time to initiation of antihypertensive medications (in patients who were not on medications at time of discharge)
Outcome measures
| Measure |
Usual Care
n=65 Participants
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
n=60 Participants
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.
|
|---|---|---|
|
Time to Medication Initiation
|
6.5 days
Interval 2.75 to 18.0
|
6.0 days
Interval 3.0 to 13.0
|
SECONDARY outcome
Timeframe: Up to 8 weeks from deliveryPopulation: The analyzed population only includes participants who were not on medications at the time of discharge.
Number of participants discharged from delivery hospitalization without antihypertensive therapy, who were subsequently started on antihypertensive therapy
Outcome measures
| Measure |
Usual Care
n=65 Participants
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
n=60 Participants
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.
|
|---|---|---|
|
Number of Participants Initiated on Antihypertensive Therapy After Hospital Discharge
|
10 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Up to 8 weeks from deliveryNumber of participants who were readmitted after delivery hospitalization discharge
Outcome measures
| Measure |
Usual Care
n=112 Participants
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
n=101 Participants
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.
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|---|---|---|
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Number of Participants Readmitted
|
7 Participants
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13 Participants
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SECONDARY outcome
Timeframe: Up to 8 weeks from deliveryNumber of participants who had an Emergency Department (ED) visit after delivery hospitalization discharge
Outcome measures
| Measure |
Usual Care
n=112 Participants
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
n=101 Participants
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.
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|---|---|---|
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Number of Participants With ED Visit
|
17 Participants
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25 Participants
|
SECONDARY outcome
Timeframe: Up to 8 weeks from deliveryNumber 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.
Outcome measures
| Measure |
Usual Care
n=112 Participants
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
n=101 Participants
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.
|
|---|---|---|
|
Number of Participants Who Developed Preeclampsia-associated Complications
|
4 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Up to 8 weeks from deliveryNumber 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
Outcome measures
| Measure |
Usual Care
n=112 Participants
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
n=101 Participants
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.
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|---|---|---|
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Number of Participants Referred to Primary Care for Continued Blood Pressure Management
|
31 Participants
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38 Participants
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SECONDARY outcome
Timeframe: Up to 8 weeks from deliveryPopulation: This questionnaire was not given to the Usual Care group since they did not participate in a telemedicine program. There were 52 respondents to the survey in the remote patient monitoring group.
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.
Outcome measures
| Measure |
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.
|
Remote Patient Monitoring
n=52 Participants
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.
|
|---|---|---|
|
Score on the Modified Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ)
|
—
|
4.03 score on a scale
Standard Deviation 0.95
|
SECONDARY outcome
Timeframe: Baseline, program end (up to 8 weeks from delivery)Population: The analyzed population only includes participants who completed both the Start Survey and the End 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. The number reported is the average score for each group.
Outcome measures
| Measure |
Usual Care
n=61 Participants
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
n=42 Participants
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.
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|---|---|---|
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Score on the Philips Program Start Survey and the Philips Program End Survey
Baseline (Start Survey)
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4.77 score on a scale
Standard Deviation 0.71
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4.57 score on a scale
Standard Deviation 2.23
|
|
Score on the Philips Program Start Survey and the Philips Program End Survey
Program End (End Survey)
|
4.59 score on a scale
Standard Deviation 0.82
|
4.55 score on a scale
Standard Deviation 0.85
|
SECONDARY outcome
Timeframe: Up to 14 days post delivery hospitalization dischargeNumber of communications between patient and obstetric provider
Outcome measures
| Measure |
Usual Care
n=112 Participants
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
n=101 Participants
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.
|
|---|---|---|
|
Communications
|
0.12 Communications
Interval 0.0 to 2.0
|
0.57 Communications
Interval 0.0 to 4.0
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Adverse Events
Usual Care
Serious events: 7 serious events
Other events: 0 other events
Deaths: 0 deaths
Remote Patient Monitoring
Serious events: 13 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Usual Care
n=112 participants at risk
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
n=101 participants at risk
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.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Readmission
|
6.2%
7/112 • Number of events 7 • 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.
|
12.9%
13/101 • Number of events 13 • 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.
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Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place