Remote BP Monitoring in the PP Period
- Conditions
- Hypertensive Disorder of Pregnancy
- Interventions
- Device: Remote Patient Monitoring
- Registration Number
- NCT03728790
- Lead Sponsor
- Columbia University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 213
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Remote Patient Monitoring 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 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 Readmitted Up to 8 weeks from delivery Number of participants who were readmitted after delivery hospitalization 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
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
Trial Locations
- Locations (1)
Columbia University Medical Center
🇺🇸New York, New York, United States