SMART-BP: Monitoring and Testing of Blood Pressure in Postpartum Women
Study Details
Study Description
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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This is a randomized control trial (RCT). All women, 18 years of age and older, delivering an infant(s) at The Birth Center at Wake Forest Baptist Medical Center and residing in Forsyth County 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 Home Visit/Stork at Home 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 (when feasible and approved by the institution) ~3 weeks after delivery.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Standard of Care (SOC) 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) 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) on loan to be used for the duration of the study (21 days total). BP monitoring smart phone app, BabyScripts™ Verbal and written instructions, to conduct BP checks at home |
Device: Remote Blood Pressure Cuff
specialized, Bluetooth enabled BP monitoring cuff
Device: Blood Pressure (BP) monitoring smart phone app, BabyScripts™
app that works with the monitoring cuff
Behavioral: Instructions
Verbal and written instructions to conduct BP checks at home
|
Outcome Measures
Primary Outcome Measures
- Median number of rBPM measures obtained [Discharge through Week 3 postpartum]
Used to determine feasibility of remote blood pressure monitoring intervention (rBPM)
- Proportion of women monitoring blood pressure (BP) according to American College of Obstetricians and Gynecologists (ACOG) guidelines [Day 10 postpartum]
Impact of rBPM on adherence to ACOG recommendations
- 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 [Discharge through week 3 postpartum]
Study team will use the electronic health record to identify encounters to the Emergency Department, OB Triage, and Urgent Care facilities
Secondary Outcome Measures
- 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]
Other Outcome Measures
- Validate and calibrate previously developed predictive algorithm [Discharge through week 8 postpartum]
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 ED/Urgent Care/OB Triage encounters and any readmissions. The predictive algorithm is informed by information documented in the electronic health record, prior to delivery and during pregnancy.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Women that deliver an infant(s) at The Birth Center at Wake Forest Baptist Medical Center
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Women that delivered an infant(s) at home or outside facility, and were transported to WFBMC and received postpartum care in The Birth Center
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Currently resides in Forsyth County, NC
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18 years of age or older
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Able to read and understand either English or Spanish
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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:
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Women that received postpartum care at any location other than The Birth Center at WFBMC
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Resides outside of Forsyth County, NC
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Under 18 years of age
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Unable to read or understand either English or Spanish
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Atrium Health Wake Forest Baptist | Winston-Salem | North Carolina | United States | 27157 |
Sponsors and Collaborators
- Wake Forest University Health Sciences
Investigators
- Principal Investigator: Elizabeth T Jensen, MPH PhD, Atrium Health Wake Forest Baptist
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB00077904