Clinical trial NCT03185455: Remote Surveillance of Postpartum Hypertension
Official title: Remote Surveillance of Postpartum Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension in Pregnancy
Keywords: Hypertension
Pregnancy
Text
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 206
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Number of Participants Whose Blood Pressure Was Assessed in the First Ten Days Following Discharge
timeFrame: 10 days postdischarge
Secondary outcomes:
measure: Number of Participants Who Required Antihypertensive Medication Initiation or Dose Adjustment Within 2 Weeks Postpartum
timeFrame: 2 weeks postpartum
measure: Number of Participants Who Required Additional ER or Office Visits for Hypertension (Not Resulting in Readmission) Within 2 Weeks Postpartum
timeFrame: 2 weeks postpartum
measure: Number of Participants With Hypertension Related Readmission Within 2 Weeks Postpartum
timeFrame: 2 weeks postpartum
measure: Patient Satisfaction
timeFrame: 2 weeks postpartum
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
References:
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.