Hypertensive Disorder of Pregnancy
Conditions
Keywords
hypertensive disorders of pregnancy, preeclampsia, gestational hypertension, HELLP
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.
Interventions
Bluetooth-enabled blood pressure cuff to assess whether this technology helps providers collect more data regarding their patients' blood pressures in the postpartum period.
Sponsors
Study design
Intervention model description
Randomized Control Trial with 2 arms
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 (excluding measurements taken at home) |
| Percentage of Participants With Elevated BP After Discharge | Up to 14 days from delivery hospitalization discharge | Incidence of elevated blood pressure (\>140 systolic or \>90 diastolic) at outpatient blood pressure assessment |
| Number of Participants With Outpatient PP Assessment | Up to 8 weeks from delivery | Number of participants who had an outpatient postpartum (PP) assessment |
| Percentage of Participants With Elevated Blood Pressure at the Postpartum Visit | Up to 8 weeks from delivery | Incidence of elevated blood pressure (\>140 systolic or \>90 diastolic) at the postpartum visit |
| 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) |
| 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 |
| Total Percentage of Elevated Blood Pressure Readings | Up to 14 days from delivery hospitalization 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). |
| 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 |
| 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. |
| 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 |
| 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. |
| Score on the Philips Program Start Survey and the Philips Program End Survey | Baseline, program end (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. The number reported is the average score for each group. |
| Communications | Up to 14 days post delivery hospitalization discharge | Number of communications between patient and obstetric provider |
| Number of Participants Readmitted | Up to 8 weeks from delivery | Number of participants who were readmitted after delivery hospitalization discharge |
Countries
United States
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 112 |
| 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. | 101 |
| Total | 213 |
Baseline characteristics
| Characteristic | Total | Usual Care | Remote Patient Monitoring |
|---|---|---|---|
| Age, Continuous | 33 years | 32 years | 33 years |
| Born outside of United States | 103 Participants | 54 Participants | 49 Participants |
| Diabetes diagnosis Gestational diabetes, diet controlled | 13 Participants | 5 Participants | 8 Participants |
| Diabetes diagnosis Gestational diabetes, insulin | 10 Participants | 7 Participants | 3 Participants |
| Diabetes diagnosis Gestational diabetes, oral agents | 5 Participants | 1 Participants | 4 Participants |
| Diabetes diagnosis Type 1 Diabetes | 1 Participants | 1 Participants | 0 Participants |
| Diabetes diagnosis Type 2 Diabetes | 5 Participants | 4 Participants | 1 Participants |
| Discharged on antihypertensive medication | 88 Participants | 47 Participants | 41 Participants |
| Drug use status Current users | 1 Participants | 0 Participants | 1 Participants |
| Drug use status Former users | 7 Participants | 6 Participants | 1 Participants |
| Employment status Employed | 141 Participants | 75 Participants | 66 Participants |
| Employment status Self-employed | 9 Participants | 4 Participants | 5 Participants |
| Employment status Unemployed | 63 Participants | 33 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 120 Participants | 67 Participants | 53 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 93 Participants | 45 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Exposure to magnesium sulfate | 78 Participants | 44 Participants | 34 Participants |
| Gestational age at delivery 20-23 6/7 weeks | 1 Participants | 0 Participants | 1 Participants |
| Gestational age at delivery 24-27 6/7 weeks | 4 Participants | 3 Participants | 1 Participants |
| Gestational age at delivery 28-33 6/7 weeks | 20 Participants | 12 Participants | 8 Participants |
| Gestational age at delivery 34-36 6/7 weeks | 36 Participants | 16 Participants | 20 Participants |
| Gestational age at delivery 37-38 6/7 weeks | 94 Participants | 52 Participants | 42 Participants |
| Gestational age at delivery 39-40 6/7 weeks | 55 Participants | 26 Participants | 29 Participants |
| Gestational age at delivery >41 weeks | 3 Participants | 3 Participants | 0 Participants |
| Highest level of education College | 51 Participants | 25 Participants | 26 Participants |
| Highest level of education Declined to answer | 3 Participants | 3 Participants | 0 Participants |
| Highest level of education Elementary school | 2 Participants | 1 Participants | 1 Participants |
| Highest level of education Graduate School | 61 Participants | 35 Participants | 26 Participants |
| Highest level of education High school | 53 Participants | 26 Participants | 27 Participants |
| Highest level of education Some college | 34 Participants | 16 Participants | 18 Participants |
| Highest level of education Some high school | 9 Participants | 6 Participants | 3 Participants |
| Married/Partnered | 165 participants | 76 participants | 89 participants |
| Multiparous | 164 Participants | 81 Participants | 83 Participants |
| Neonatal disposition Fetal Demise | 1 Participants | 1 Participants | 0 Participants |
| Neonatal disposition Neonatal Demise | 1 Participants | 1 Participants | 0 Participants |
| Neonatal disposition Neonatal intensive care unit (NICU) admission | 47 Participants | 28 Participants | 19 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 16 Participants | 11 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 64 Participants | 32 Participants | 32 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 28 Participants | 19 Participants | 9 Participants |
| Race (NIH/OMB) White | 103 Participants | 48 Participants | 55 Participants |
| Religion Christian | 112 Participants | 57 Participants | 55 Participants |
| Religion Hindu | 2 Participants | 0 Participants | 2 Participants |
| Religion Jehovah's Witness | 3 Participants | 3 Participants | 0 Participants |
| Religion Jewish | 11 Participants | 4 Participants | 7 Participants |
| Religion Muslim | 6 Participants | 4 Participants | 2 Participants |
| Religion None | 71 Participants | 37 Participants | 34 Participants |
| Religion Other | 8 Participants | 7 Participants | 1 Participants |
| Sex: Female, Male Female | 213 Participants | 112 Participants | 101 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Smoking status Current Smokers | 1 Participants | 0 Participants | 1 Participants |
| Smoking status Former Smokers | 11 Participants | 6 Participants | 5 Participants |
| Time of initiation of prenatal care First trimester | 166 Participants | 84 Participants | 82 Participants |
| Time of initiation of prenatal care No prenatal care | 1 Participants | 0 Participants | 1 Participants |
| Time of initiation of prenatal care Second trimester | 39 Participants | 24 Participants | 15 Participants |
| Time of initiation of prenatal care Third trimester | 3 Participants | 1 Participants | 2 Participants |
| Time of initiation of prenatal care Unknown | 4 Participants | 3 Participants | 1 Participants |
| Type of delivery Cesarean Delivery | 113 Participants | 56 Participants | 57 Participants |
| Type of delivery Forceps-assisted Vaginal Delivery | 4 Participants | 3 Participants | 1 Participants |
| Type of delivery Spontaneous Vaginal Delivery | 96 Participants | 53 Participants | 43 Participants |
| Type of hypertension Chronic Hypertension | 29 Participants | 14 Participants | 15 Participants |
| Type of hypertension Eclampsia | 1 Participants | 0 Participants | 1 Participants |
| Type of hypertension Gestational Hypertension | 71 Participants | 38 Participants | 33 Participants |
| Type of hypertension Preeclampsia without severe features | 29 Participants | 12 Participants | 17 Participants |
| Type of hypertension Preeclampsia with severe features/HELLP Syndrome | 62 Participants | 36 Participants | 26 Participants |
| Type of hypertension Superimposed preeclampsia | 21 Participants | 12 Participants | 9 Participants |
| Type of insurance Private Insurance | 125 Participants | 65 Participants | 60 Participants |
| Type of insurance Public Insurance | 88 Participants | 47 Participants | 41 Participants |
| Type of prenatal care Generalist | 117 Participants | 62 Participants | 55 Participants |
| Type of prenatal care Maternal fetal medicine (MFM) | 88 Participants | 45 Participants | 43 Participants |
| Type of prenatal care No prenatal care | 8 Participants | 5 Participants | 3 Participants |
| Urgent antihypertensive medication antepartum or intrapartum | 36 Participants | 21 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 112 | 0 / 101 |
| other Total, other adverse events | 0 / 112 | 0 / 101 |
| serious Total, serious adverse events | 7 / 112 | 13 / 101 |
Outcome results
Blood Pressure (BP) Surveillance Adherence
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Usual Care | Blood Pressure (BP) Surveillance Adherence | 0.0 percentage of recommended BPs reported |
| Remote Patient Monitoring | Blood Pressure (BP) Surveillance Adherence | 61.1 percentage of recommended BPs reported |
Communications
Number of communications between patient and obstetric provider
Time frame: Up to 14 days post delivery hospitalization discharge
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Communications | 0.12 Communications |
| Remote Patient Monitoring | Communications | 0.57 Communications |
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
Time frame: Up to 8 weeks from delivery
Population: The analyzed population only includes participants who were not on medications at the time of discharge.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Number of Participants Initiated on Antihypertensive Therapy After Hospital Discharge | 10 Participants |
| Remote Patient Monitoring | Number of Participants Initiated on Antihypertensive Therapy After Hospital Discharge | 24 Participants |
Number of Participants Readmitted
Number of participants who were readmitted after delivery hospitalization discharge
Time frame: Up to 8 weeks from delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Number of Participants Readmitted | 7 Participants |
| Remote Patient Monitoring | Number of Participants Readmitted | 13 Participants |
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
Time frame: Up to 8 weeks from delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Number of Participants Referred to Primary Care for Continued Blood Pressure Management | 31 Participants |
| Remote Patient Monitoring | Number of Participants Referred to Primary Care for Continued Blood Pressure Management | 38 Participants |
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.
Time frame: Up to 8 weeks from delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Number of Participants Who Developed Preeclampsia-associated Complications | 4 Participants |
| Remote Patient Monitoring | Number of Participants Who Developed Preeclampsia-associated Complications | 9 Participants |
Number of Participants With ED Visit
Number of participants who had an Emergency Department (ED) visit after delivery hospitalization discharge
Time frame: Up to 8 weeks from delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Number of Participants With ED Visit | 17 Participants |
| Remote Patient Monitoring | Number of Participants With ED Visit | 25 Participants |
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 (excluding measurements taken at home)
Time frame: Up to 14 days from delivery hospitalization discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Number of Participants With Outpatient BP Assessment Within 14 Days | 69 Participants |
| Remote Patient Monitoring | Number of Participants With Outpatient BP Assessment Within 14 Days | 59 Participants |
Number of Participants With Outpatient PP Assessment
Number of participants who had an outpatient postpartum (PP) assessment
Time frame: Up to 8 weeks from delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Number of Participants With Outpatient PP Assessment | 88 Participants |
| Remote Patient Monitoring | Number of Participants With Outpatient PP Assessment | 82 Participants |
Percentage of Participants With Elevated Blood Pressure at the Postpartum Visit
Incidence of elevated blood pressure (\>140 systolic or \>90 diastolic) at the postpartum visit
Time frame: Up to 8 weeks from delivery
Population: The analyzed population only includes participants who had an outpatient postpartum assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Percentage of Participants With Elevated Blood Pressure at the Postpartum Visit | 13.6 percentage of participants |
| Remote Patient Monitoring | Percentage of Participants With Elevated Blood Pressure at the Postpartum Visit | 17.1 percentage of participants |
Percentage of Participants With Elevated BP After Discharge
Incidence of elevated blood pressure (\>140 systolic or \>90 diastolic) at outpatient blood pressure assessment
Time frame: Up to 14 days from delivery hospitalization discharge
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Percentage of Participants With Elevated BP After Discharge | 27.9 percentage of participants |
| Remote Patient Monitoring | Percentage of Participants With Elevated BP After Discharge | 24.5 percentage of participants |
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.
Time frame: Up to 8 weeks from delivery
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Remote Patient Monitoring | Score on the Modified Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ) | 4.03 score on a scale | Standard Deviation 0.95 |
Score on the Philips Program Start Survey and the Philips Program 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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Score on the Philips Program Start Survey and the Philips Program End Survey | Baseline (Start Survey) | 4.77 score on a scale | Standard Deviation 0.71 |
| Usual Care | 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 |
| Remote Patient Monitoring | Score on the Philips Program Start Survey and the Philips Program End Survey | Baseline (Start Survey) | 4.57 score on a scale | Standard Deviation 2.23 |
| Remote Patient Monitoring | Score on the Philips Program Start Survey and the Philips Program End Survey | Program End (End Survey) | 4.55 score on a scale | Standard Deviation 0.85 |
Time to Medication Initiation
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
Population: The analyzed population only includes participants in each arm who were not on medications at the time of discharge.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Usual Care | Time to Medication Initiation | 6.5 days |
| Remote Patient Monitoring | Time to Medication Initiation | 6.0 days |
Total Percentage of Elevated Blood Pressure Readings
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).
Time frame: Up to 14 days from delivery hospitalization discharge
Population: The analyzed population only includes participants who recorded at least one blood pressure at home after hospital discharge.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Total Percentage of Elevated Blood Pressure Readings | 37.52 percentage of elevated BP readings |
| Remote Patient Monitoring | Total Percentage of Elevated Blood Pressure Readings | 49.6 percentage of elevated BP readings |