The purpose of this research study is to find out the usefulness of checking a woman's blood pressure remotely (at home) for 3 weeks after being discharged from the hospital after having a baby (or babies). Some women can develop hypertension, or high blood pressure, after delivery even if they have not had this problem before or during their pregnancy. Untreated or unknown high blood pressure can lead to medical complications, and if severe, can be life threatening. Monitoring, or checking, remote blood pressure after a woman has delivered her baby (or babies) has been suggested to be a better way to monitor blood pressures without having to stay in the hospital for a longer time after delivery. Other researchers report that women who have checked their blood pressure remotely after delivery found out that this was both possible and acceptable.
This is a randomized control trial. All women, 18 years of age and older, delivering an infant(s) at The Birth Center at Atrium Health Wake Forest Baptist and residing in Forsyth County, North Carolina that have been approached by our Home Visit Coordinators will be eligible for enrollment and invited to participate in the SMART-BP study prior to discharge from the postpartum unit. Per established protocols, the Home Visit Coordinators for the Nurse Education Support Team Program attempt to approach all women that deliver in The Birth Center and who reside in Forsyth County. At this initial introduction, the Home Visit Coordinators determine if the patient has any need for, or interest in, any of the vetted community resources available to her and her family. Information about any of these resources are provided to the patient at that time. Additionally, the Home Visit Coordinators offer to schedule a nurse "home visit." This nurse home visit occurs via phone call, telehealth visit, or an in person visit approximately 2 weeks after delivery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
1,607
specialized, Bluetooth enabled blood pressure monitoring cuff
app that works with the monitoring cuff
Verbal and written instructions to conduct blood pressure checks at home
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States
Median Number of Remote Blood Pressure (rBPM) Measurements Obtained Per Participant
Used to determine feasibility of remote blood pressure monitoring intervention (rBPM) in postpartum women. This measure represents the median number of remote blood pressure monitoring (rBPM) measurements collected per participant during the study period. The total number of rBPM readings obtained for each participant was calculated, and the median value across all participants in the analysis population was reported
Time frame: Discharge through Week 3 postpartum
Proportion of Participants Monitoring Blood Pressure (BP) According to American College of Obstetricians and Gynecologists (ACOG) Guidelines
This outcome measures the proportion of participants whose postpartum blood pressure monitoring adhered to American College of Obstetricians and Gynecologists (ACOG) recommendations. Adherence includes: Initial Monitoring (first 72 hours postpartum): inpatient or equivalent monitoring for women with pregnancy-related hypertension; and Early Follow-Up (3-10 days postpartum): documentation of a follow-up visit or remote blood pressure check within 3-10 days after hospital discharge. Monitoring data will be obtained from electronic health records and remote blood pressure monitoring logs. Participants are counted once if they met both ACOG-recommended monitoring intervals.
Time frame: Discharge through Day 10 postpartum
Median Total Cost of Health Care
Cost of hospital based medical care of subjects in US dollars.
Time frame: From discharge through week 8 postpartum
Number of Participants Experiencing at Least One Day With a Severe Hypertension Event
This measure captures the number of participants who experienced one or more days in which a severe hypertension event occurred. A participant is counted once if they had ≥1 day meeting severe hypertension criteria, regardless of the total number of qualifying days. A severe or critical hypertensive event is defined as any blood pressure reading in which the systolic value is ≥160 mmHg and/or the diastolic value is ≥110 mmHg.
Time frame: Discharge through week 1 postpartum
Number of Participants Experiencing at Least One Day With a Severe Hypertension Event
This measure captures the number of participants who experienced one or more days in which a severe hypertension event occurred. A participant is counted once if they had ≥1 day meeting severe hypertension criteria, regardless of the total number of qualifying days. A severe or critical hypertensive event is defined as any blood pressure reading in which the systolic value is ≥160 mmHg and/or the diastolic value is ≥110 mmHg.
Time frame: Discharge through week 3 postpartum
Number of Participants With One or More Urgent or Emergent Care Encounters
The study team will use the electronic health record (EHR) to identify the number of participants who had one or more encounters at Emergency Department, Obstetric Triage, or Urgent Care facilities affiliated with Atrium Health Wake Forest Baptist. Encounters will be identified using visit type classifications and associated encounter codes documented in the EHR. Only encounters occurring within the specified study time frame and attributable to enrolled participants will be included. Each participant will be counted once regardless of the total number of urgent or emergent care visits they experienced.
Time frame: Discharge through week 3 postpartum
Median Number of Encounters for Urgent or Emergent Care
Study team will use the electronic health record to identify encounters to the Emergency Department, OB Triage, and Urgent Care facilities
Time frame: Discharge through week 8 postpartum
Acceptability of rBPM in Postpartum Period
Survey to determine subject's level of satisfaction with use of the rBPM tools. Survey responses will be compared among subjects from varying demographic and socioeconomic groups. Survey is designed utilizing a Likert-type scale with 1-2 being higher level of acceptability, 3 being neutral, and 4-5 being lower level of acceptability of the rBPM tools. Study team will report the overall proportion and estimate the proportion of women with higher vs. lower levels of acceptability among women of different demographic and socioeconomic groups. This aim only applies to the women in the treatment (rBPM) arm.
Time frame: Week 3 postpartum
Median Length of Stay (LOS) in Hospital After Delivery
Time frame: Baseline (date of delivery) through discharge, assessed for up to 8 weeks postpartum
Median Number of Hospital Readmissions
Time frame: Discharge through week 8 postpartum
Median Length of Stay (LOS) for Hospital Readmissions
Time frame: Discharge through week 8 postpartum
Median Number of Women That Have a Follow-up Encounter Scheduled With Their Primary Care Physician (PCP) Within 12 Months After Delivery
Time frame: Discharge through 12 months postpartum
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