Hypertension
Conditions
Keywords
postpartum, blood pressure, women, blood pressure monitoring
Brief summary
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.
Detailed description
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.
Interventions
DEVICERemote Blood Pressure Cuff
specialized, Bluetooth enabled blood pressure monitoring cuff
DEVICEBlood pressure monitoring smart phone app, BabyScripts™
app that works with the monitoring cuff
BEHAVIORALInstructions
Verbal and written instructions to conduct blood pressure checks at home
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Women that received prenatal care at one of the Atrium Health Wake Forest Baptist Obstetrics/Maternal-Fetal Medicine outpatient clinic locations in Forsyth County, North Carolina * Women that delivered an infant(s) at The Birth Center at Atrium Health Wake Forest Baptist * Women that delivered an infant(s) at home or outside facility, and were transported to Atrium Health Wake Forest Baptist and received postpartum care in The Birth Center * Currently resides in Forsyth County, North Carolina * Able to read and understand either English or Spanish * Owns or has daily access to a smart phone (iOS or Android operating system) with available Wi-Fi or monthly mobile data plan
Exclusion criteria
* Women that received postpartum care at any location other than The Birth Center at Atrium Health Wake Forest Baptist * Resides outside of Forsyth County, North Carolina * Under 18 years of age * Unable to read or understand either English or Spanish * Does not own or have daily access to a smart phone (iOS or Android operating system) with available Wi-Fi or monthly mobile data plan
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Number of Remote Blood Pressure (rBPM) Measurements Obtained Per Participant | Discharge through Week 3 postpartum | 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 |
| Proportion of Participants Monitoring Blood Pressure (BP) According to American College of Obstetricians and Gynecologists (ACOG) Guidelines | Discharge through Day 10 postpartum | 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. |
| Median Total Cost of Health Care | From discharge through week 8 postpartum | Cost of hospital based medical care of subjects in US dollars. |
| Number of Participants Experiencing at Least One Day With a Severe Hypertension Event | Discharge through week 1 postpartum | 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. |
| Number of Participants With One or More Urgent or Emergent Care Encounters | Discharge through week 3 postpartum | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Number of Encounters for Urgent or Emergent Care | Discharge through week 8 postpartum | Study team will use the electronic health record to identify encounters to the Emergency Department, OB Triage, and Urgent Care facilities |
| Acceptability of rBPM in Postpartum Period | Week 3 postpartum | 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. |
| Median Length of Stay (LOS) in Hospital After Delivery | Baseline (date of delivery) through discharge, assessed for up to 8 weeks postpartum | — |
| Median Number of Hospital Readmissions | Discharge through week 8 postpartum | — |
| Median Length of Stay (LOS) for Hospital Readmissions | 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 | Discharge through 12 months postpartum | — |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORElizabeth T Jensen, MPH PhD
Atrium Health Wake Forest Baptist
Participant flow
Recruitment details
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
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 30.3 years STANDARD_DEVIATION 6.06 |
| Race/Ethnicity, Customized Ethnicity Ethnicity: Hispanic or Latino | 229 Participants |
| Race/Ethnicity, Customized Ethnicity Ethnicity: Not Hispanic or Latino | 446 Participants |
| Race/Ethnicity, Customized Ethnicity Ethnicity: Prefer not to say | 53 Participants |
| Race/Ethnicity, Customized Ethnicity Ethnicity: Some other race, ethnicity or origin | 16 Participants |
| Race/Ethnicity, Customized Ethnicity Ethnicity: Unknown or not reported/missing | 23 Participants |
| Race/Ethnicity, Customized Race Race: American Indian or Alaska Native | 11 Participants |
| Race/Ethnicity, Customized Race Race: AsIan | 36 Participants |
| Race/Ethnicity, Customized Race Race: Black or African American | 178 Participants |
| Race/Ethnicity, Customized Race Race: More than one race | 18 Participants |
| Race/Ethnicity, Customized Race Race: Native Hawaiian or Other Pacific Islander | 4 Participants |
| Race/Ethnicity, Customized Race Race: Prefer not to say | 72 Participants |
| Race/Ethnicity, Customized Race Race: Prefer to self-describe | 14 Participants |
| Race/Ethnicity, Customized Race Race: Some other race, ethnicity, or origin | 118 Participants |
| Race/Ethnicity, Customized Race Race: Unknown or not reported/missing | 23 Participants |
| Race/Ethnicity, Customized Race Race: White | 286 Participants |
| Sex: Female, Male Female | 1525 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 797 | 0 / 728 |
| other Total, other adverse events | 45 / 797 | 116 / 728 |
| serious Total, serious adverse events | 26 / 797 | 34 / 728 |
Outcome results
None listed