Trial Outcomes & Findings for Monitoring and Testing of Blood Pressure in Postpartum Women (NCT NCT05236725)

All women, 18 years of age and older, who have delivered or are planning to deliver an infant(s) at The Birth Center at Atrium Health Wake Forest Baptist and reside in Forsyth County will be eligible for enrollment and invited to participate in the SMART-BP study. We enrolled women during the prenatal period from the Atrium Health Wake Forest Baptist Obstetrics clinics as well as after delivery. Enrollment period was 3/1/2022 through 8/30/2024

Monitoring and Testing of Blood Pressure in Postpartum Women

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

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.

Cost of hospital based medical care of subjects in US dollars.

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.

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.

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.

Study team will use the electronic health record to identify encounters to the Emergency Department, OB Triage, and Urgent Care facilities

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.

Intended to assess the performance of the predictive algorithm in identifying postpartum high blood pressure readmissions. Study team will utilize blood pressure measures obtained through 3 weeks postpartum, as well as any hypertensive disorders of pregnancy events postpartum through 8 weeks postpartum, to include Emergency Department/Urgent Care/Obstetrics Triage encounters and any readmissions. The predictive algorithm is informed by information documented in the electronic health record, prior to delivery and during pregnancy.