Remote Surveillance of Postpartum Hypertension (TextBP)

Women with hypertensive disorders of pregnancy need postpartum blood pressure (BP) surveillance to detect persistent hypertension. Various barriers result in only 30% attendance at postpartum BP visits. A more effective strategy is needed. Women with hypertension of pregnancy will be randomized to either text-based monitoring or office visits. Those randomized to the intervention will receive a BP cuff and text in their BP to an automated, clinician derived, HIPAA compliant text-based algorithm.

Study Overview

• Status: Completed
• Conditions: Hypertension in Pregnancy
• Intervention / Treatment: Other: Remote (text based) surveillance

Detailed Description

Hypertension is a leading cause of maternal morbidity, mortality and obstetrical readmissions. Peak blood pressure usually occurs 3-6 days postpartum, and is typically unaccompanied by warning symptoms. Although there is a clear need for effective and reliable blood pressure surveillance after delivery, there are significant obstacles to in-person visits in the immediate postpartum period, including sleep deprivation, newborn care, and transportation needs. These barriers have proven real as we observed only 30-50% attendance to office blood pressure visits following delivery. This proposal will investigate whether text-based communication between patients and providers is an effective alternative method for monitoring postpartum hypertension in at risk women.

Women with hypertensive disorders of pregnancy with access to a cell phone with unlimited text message capabilities will be randomized to either office visit blood pressure checks after discharge or receive a blood pressure cuff and text in blood pressures for two weeks postpartum using a standardized, HIPAA compliant, physician derived automated platform.

• Study Type: Interventional
• Enrollment (Actual): 206
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women with chronic hypertension, gestational hypertension, or preeclampsia who deliver at the Hospital of the University of Pennsylvania will be eligible to participate. All patients must be > 18 years old, able to speak and read English, have a hypertension diagnosis, and have access to a cell phone with unlimited text message capabilities.

Exclusion Criteria:

• Women without access to a cell phone with unlimited text message capabilities will be excluded from the study in order to eliminate barriers to participate in remote surveillance. However, we will track the number of women not eligible for this reason in order to understand generalizability in an urban population.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care; Those randomized to the standard protocol for blood pressure monitoring will be scheduled for an office based nursing blood pressure visits 4-6 days postpartum. Care at this visit is based on a physician derived algorithm.
Experimental: Remote (text based) surveillance; Those randomized to remote surveillance will be provided with electronic blood pressure monitors prior to discharge and instructed on their use. Every day, for two weeks post-discharge, patients will receive a standard text message in the morning from a HIPAA compliant automated monitoring system reminding them to text their blood pressure. They will be asked to send in one blood pressure a day at minimum. They may be asked to send in more depending on the blood pressure result and clinical algorithm. This system will provide timely responses to patient texts and create a physician derived response to elevated blood pressures based on a programmed algorithm. Additionally, for blood pressures that reach a dangerous threshold, a clinical provider will be alerted per the algorithm and contact the patient for further evaluation.	Other: Remote (text based) surveillance; Women with hypertensive disorders of pregnancy with access to a cell phone with unlimited text message capabilities will be randomized to either office visit blood pressure checks after discharge or receive a blood pressure cuff and text in blood pressures for two weeks postpartum using a standardized, HIPAA compliant, physician derived automated platform.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Whose Blood Pressure Was Assessed in the First Ten Days Following Discharge	the percentage of patients in which a single blood pressure is obtained in the first 10 days following discharge. Within the texting group, the percentage of patients in whom blood pressures values are obtained at 72 hours and 7-10 days postpartum, in accordance with American College of Obstetricians and Gynecologists recommendations, will be assessed as well.	10 days postdischarge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Required Antihypertensive Medication Initiation or Dose Adjustment Within 2 Weeks Postpartum	Number of participants who required antihypertensive medication initiation or dose adjustment within 2 weeks postpartum	2 weeks postpartum
Number of Participants Who Required Additional ER or Office Visits for Hypertension (Not Resulting in Readmission) Within 2 Weeks Postpartum	Number of participants who required additional ER or office visits for hypertension (not resulting in readmission) within 2 weeks postpartum	2 weeks postpartum
Number of Participants With Hypertension Related Readmission Within 2 Weeks Postpartum	Number of participants with hypertension related readmission within 2 weeks postpartum	2 weeks postpartum
Patient Satisfaction	Patient who would recommend the program to a family or friend as per the Patient Satisfaction Survey completed at 2 weeks postpartum.	2 weeks postpartum

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Publications and helpful links

General Publications

• Hirshberg A, Downes K, Srinivas S. Comparing standard office-based follow-up with text-based remote monitoring in the management of postpartum hypertension: a randomised clinical trial. BMJ Qual Saf. 2018 Nov;27(11):871-877. doi: 10.1136/bmjqs-2018-007837. Epub 2018 Apr 27.

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2016
• Primary Completion (Actual): January 20, 2017
• Study Completion (Actual): January 23, 2017

Study Registration Dates

• First Submitted: June 6, 2017
• First Submitted That Met QC Criteria: June 12, 2017
• First Posted (Actual): June 14, 2017

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Hypertension; Pregnancy; Text
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Pregnancy Complications; Hypertension; Hypertension, Pregnancy-Induced
• Other Study ID Numbers: 825390

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No