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Remote Surveillance of Postpartum Hypertension (TextBP)

Primary Purpose

Hypertension in Pregnancy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Remote (text based) surveillance
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypertension in Pregnancy focused on measuring Hypertension, Pregnancy, Text

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital of the University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of Care

Remote (text based) surveillance

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
Number of Participants With Hypertension Related Readmission Within 2 Weeks Postpartum
Number of participants with hypertension related readmission within 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.

Full Information

First Posted
June 6, 2017
Last Updated
April 10, 2023
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT03185455
Brief Title
Remote Surveillance of Postpartum Hypertension
Acronym
TextBP
Official Title
Remote Surveillance of Postpartum Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
August 22, 2016 (Actual)
Primary Completion Date
January 20, 2017 (Actual)
Study Completion Date
January 23, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension in Pregnancy
Keywords
Hypertension, Pregnancy, Text

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study will be a randomized, two arm trial. Patient will be randomized to usual one time office visit based blood pressure check or to text-message based remote surveillance for two weeks. Randomization will be performed using a computer generated sequence using REDCAP. Demographic information will be collected from those who decline randomization or are ineligible in order to assess patient characteristics of those willing to be randomized and who meet eligibility.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
206 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
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.
Arm Title
Remote (text based) surveillance
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Remote (text based) surveillance
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants Whose Blood Pressure Was Assessed in the First Ten Days Following Discharge
Description
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.
Time Frame
10 days postdischarge
Secondary Outcome Measure Information:
Title
Number of Participants Who Required Antihypertensive Medication Initiation or Dose Adjustment Within 2 Weeks Postpartum
Description
Number of participants who required antihypertensive medication initiation or dose adjustment within 2 weeks postpartum
Time Frame
2 weeks postpartum
Title
Number of Participants Who Required Additional ER or Office Visits for Hypertension (Not Resulting in Readmission) Within 2 Weeks Postpartum
Description
Number of participants who required additional ER or office visits for hypertension (not resulting in readmission) within 2 weeks postpartum
Time Frame
2 weeks postpartum
Title
Number of Participants With Hypertension Related Readmission Within 2 Weeks Postpartum
Description
Number of participants with hypertension related readmission within 2 weeks postpartum
Time Frame
2 weeks postpartum
Title
Patient Satisfaction
Description
Patient who would recommend the program to a family or friend as per the Patient Satisfaction Survey completed at 2 weeks postpartum.
Time Frame
2 weeks postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29703800
Citation
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.
Results Reference
derived

Learn more about this trial

Remote Surveillance of Postpartum Hypertension

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