Monitoring and Testing of Blood Pressure in Postpartum Women

Study Overview
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Brief Summary
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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 BP, after delivery even if they have not had this problem before or during their pregnancy. Untreated or unknown high BP can lead to medical complications, and if severe, can be life threatening. Monitoring, or checking, remote BP after a woman has delivered her baby (or babies) has been suggested to be a better way to monitor BPs without having to stay in the hospital for a longer time after delivery. Other researchers report that women who have checked their BP remotely after delivery found out that this was both possible and acceptable.

Detailed Description
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This is a randomized control trial (RCT). 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, NC 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  2 weeks after delivery.

Official Title
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Systematic Monitoring and Remote Testing of Blood Pressure in Postpartum Women

Conditions
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Hypertension

Intervention / Treatment
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* Device: Remote Blood Pressure Cuff
* Device: Blood Pressure (BP) monitoring smart phone app, BabyScripts™
* Behavioral: Instructions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women that received prenatal care at one of the Atrium Health Wake Forest Baptist OB/MFM outpatient clinic locations in Forsyth County, NC 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, NC 18 years of age or older 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, NC 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care (SOC)<br>Subjects randomized to SOC arm are provided with the appropriate standard of care depending upon their risk level (as determined by their individual provider or WFBMC Maternal-Fetal Medicine provider) | |
| Experimental: Remote Blood Pressure Monitoring (rBPM)<br>Subjects randomized to rBPM arm receive the appropriate standard of care depending upon their risk level, as well as the remote BP monitoring app (BabyScripts) and Bluetooth enabled BP cuff/monitor, and will receive the following equipment and monitoring: a specialized, Bluetooth enabled BP monitoring cuff (Clinically Validated, A&D Medical Wireless Blood Pressure Monitor-Upper Arm (Appendix 2) BP monitoring smart phone app, BabyScripts™ Verbal and written instructions, to conduct BP checks at home | Device: Remote Blood Pressure Cuff<br>* specialized, Bluetooth enabled BP monitoring cuff<br>Device: Blood Pressure (BP) monitoring smart phone app, BabyScripts™<br>* app that works with the monitoring cuff<br>Behavioral: Instructions<br>* Verbal and written instructions to conduct BP checks at home<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median number of rBPM measures obtained | Used to determine feasibility of remote blood pressure monitoring intervention (rBPM) | Discharge through Week 3 postpartum | 
| Proportion of women monitoring blood pressure (BP) according to American College of Obstetricians and Gynecologists (ACOG) guidelines | Impact of rBPM on adherence to ACOG recommendations | Day 10 postpartum | 
| Median total cost of health care |  | From discharge through week 8 postpartum | 
| Median number of Severe Hypertension events |  | Discharge through week 1 postpartum | 
| Median number of Severe Hypertension events |  | 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 | Discharge through week 3 postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | Week 3 postpartum | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postpartum, blood pressure, women, blood pressure monitoring