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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
213
Bluetooth-enabled blood pressure cuff to assess whether this technology helps providers collect more data regarding their patients' blood pressures in the postpartum period.
Columbia University Medical Center
New York, New York, United States
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
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
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
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
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
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
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Time frame: Up to 8 weeks from delivery
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
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
Number of Participants Readmitted
Number of participants who were readmitted after delivery hospitalization discharge
Time frame: Up to 8 weeks from delivery
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
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
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
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
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)
Communications
Number of communications between patient and obstetric provider
Time frame: Up to 14 days post delivery hospitalization discharge