Hypertension in Pregnancy
Conditions
Keywords
Hypertension, Pregnancy, Text
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.
Interventions
OTHERRemote (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.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Whose Blood Pressure Was Assessed in the First Ten Days Following Discharge | 10 days postdischarge | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Required Antihypertensive Medication Initiation or Dose Adjustment Within 2 Weeks Postpartum | 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 | 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 | 2 weeks postpartum | Number of participants with hypertension related readmission within 2 weeks postpartum |
| Patient Satisfaction | 2 weeks postpartum | Patient who would recommend the program to a family or friend as per the Patient Satisfaction Survey completed at 2 weeks postpartum. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care Women randomized to the standard protocol for blood pressure monitoring will be scheduled for an office based nursing blood pressure visits 4-6 days postpartum. The date and time of the office appointment is specified in the discharge document and reviewed with the patient prior to discharge. Care at this visit is based on a physician derived algorithm. | 103 |
| Remote (Text Based) Surveillance Women randomized to the text-based surveillance arm will be given an automatic Omron© blood pressure cuff and instructed on use by research team members prior to discharge. Patients will be enrolled into the texting program platform developed through Way to Health. A starting introductory text message is sent by the Way to Health platform to the phone number provided on day of discharge. Patients receive reminders to text message their blood pressures twice daily for two weeks postpartum, starting on the day after discharge. Immediate feedback is provided to the patient based on a preprogrammed automated algorithm. The primary investigator is alerted with pre-specified severe range blood pressure values (systolic blood pressure \> 160 mmHg or diastolic \> 100 mmHg) via text message or email and care is escalated as needed based on the same outpatient algorithm used in the office.
Remote (text based) surveillance: Women with hypertensive disorders of pregnancy with access to | 103 |
| Total | 206 |
Baseline characteristics
| Characteristic | Standard of Care | Remote (Text Based) Surveillance | Total |
|---|---|---|---|
| Age, Continuous | 28 years STANDARD_DEVIATION 5 | 28 years STANDARD_DEVIATION 6 | 28 years STANDARD_DEVIATION 5.9 |
| Body Mass Index | 31 kg/m^2 | 30.1 kg/m^2 | 30.2 kg/m^2 |
| Breastfeeding | 72 Participants | 71 Participants | 143 Participants |
| Cesarean delivery in labor | 18 Participants | 23 Participants | 41 Participants |
| Chronic hypertension with antihypertensive medication | 6 Participants | 5 Participants | 11 Participants |
| Chronic hypertension without antihypertensive medication | 7 Participants | 9 Participants | 16 Participants |
| Discharged on oral antihypertensive medication | 19 Participants | 24 Participants | 43 Participants |
| Eclampsia | 0 Participants | 1 Participants | 1 Participants |
| Gestational age at delivery | 38 weeks | 38 weeks | 38 weeks |
| Gestational age at diagnosis | 38 weeks | 38 weeks | 38 weeks |
| Gestational diabetes | 8 Participants | 6 Participants | 14 Participants |
| Gestational hypertension/preeclampsia without severe features | 68 Participants | 63 Participants | 131 Participants |
| Hemolysis Elevated Liver Enzymes Low Platelet syndrome | 3 Participants | 0 Participants | 3 Participants |
| Induction of labor | 58 Participants | 54 Participants | 112 Participants |
| Live birth | 100 Participants | 100 Participants | 200 Participants |
| Magnesium sulfate use | 32 Participants | 35 Participants | 67 Participants |
| Medicaid Insurance | 61 Participants | 59 Participants | 120 Participants |
| Nulliparous | 52 Participants | 61 Participants | 113 Participants |
| Planned cesarean delivery | 16 Participants | 10 Participants | 26 Participants |
| Postpartum discharge day | 2 day | 2 day | 2 day |
| Preeclampsia with severe features | 22 Participants | 25 Participants | 47 Participants |
| Pregestational diabetes | 3 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 73 Participants | 68 Participants | 141 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 5 Participants | 6 Participants |
| Race (NIH/OMB) White | 25 Participants | 28 Participants | 53 Participants |
| Region of Enrollment United States | 103 participants | 103 participants | 206 participants |
| Renal disease | 5 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Female | 103 Participants | 103 Participants | 206 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Superimposed preeclampsia | 10 Participants | 14 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 103 | 0 / 103 |
| other Total, other adverse events | 0 / 103 | 0 / 103 |
| serious Total, serious adverse events | 0 / 103 | 0 / 103 |
Outcome results
Primary
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.
Time frame: 10 days postdischarge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care | Number of Participants Whose Blood Pressure Was Assessed in the First Ten Days Following Discharge | 45 Participants |
| Remote (Text Based) Surveillance | Number of Participants Whose Blood Pressure Was Assessed in the First Ten Days Following Discharge | 95 Participants |
Secondary
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
Time frame: 2 weeks postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care | Number of Participants Who Required Additional ER or Office Visits for Hypertension (Not Resulting in Readmission) Within 2 Weeks Postpartum | 2 Participants |
| Remote (Text Based) Surveillance | Number of Participants Who Required Additional ER or Office Visits for Hypertension (Not Resulting in Readmission) Within 2 Weeks Postpartum | 3 Participants |
Secondary
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
Time frame: 2 weeks postpartum
Population: Only women who attended the office visit were analyzed in the standard of care group
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care | Number of Participants Who Required Antihypertensive Medication Initiation or Dose Adjustment Within 2 Weeks Postpartum | 10 Participants |
| Remote (Text Based) Surveillance | Number of Participants Who Required Antihypertensive Medication Initiation or Dose Adjustment Within 2 Weeks Postpartum | 17 Participants |
Secondary
Number of Participants With Hypertension Related Readmission Within 2 Weeks Postpartum
Number of participants with hypertension related readmission within 2 weeks postpartum
Time frame: 2 weeks postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care | Number of Participants With Hypertension Related Readmission Within 2 Weeks Postpartum | 4 Participants |
| Remote (Text Based) Surveillance | Number of Participants With Hypertension Related Readmission Within 2 Weeks Postpartum | 0 Participants |
Secondary
Patient Satisfaction
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
Population: The data population analyzed in the Remote Surveillance Arm included only those who completed the satisfaction survey. Participants in the standard of care arm were not eligible to complete the Patient Satisfaction Survey since they did not receive the intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care | Patient Satisfaction | 0 Participants |
| Remote (Text Based) Surveillance | Patient Satisfaction | 77 Participants |