Chronic Hypertension Complicating Pregnancy, Gestational Hypertension, Preeclampsia
Conditions
Keywords
chronic or gestational hypertension, preeclampsia, remote blood pressure monitoring, smartphone application
Brief summary
Remote postpartum blood pressure monitoring program with text messages has been shown to increase adherence to recommended postpartum blood pressure checks among those with hypertension at discharge from birth hospitalization, but these programs require medically trained professionals to respond to each individual text message. A bluetooth-enabled blood pressure cuff that synchs automatically a smartphone application that leverages Artificial Intelligence to provide tailored recommendations based on recorded blood pressure measurements--and can also provide on-demand education on hypertension--may be less costly way to provide similar support.
Detailed description
Preeclampsia or gestational hypertension-described as hypertension in pregnancy-affects up to 10% of all pregnancies and is a main driver of maternal morbidity in Rhode Island and the United States. The rates of hypertension in pregnancy have disproportionately affected women of color and may explain why racial minorities have higher maternal morbidity. The American College of Obstetricians and Gynecologists has called for novel interventions to improve health equity and maternal morbidity outcomes among women hypertension in pregnancy. Technology-based interventions (i.e. remote blood pressure monitoring, telehealth visits, text-based communication) have improved access to care but, to date, have not yet demonstrated an effect on reducing maternal morbidity outcomes. It is possible that the lack of effect on maternal morbidity is due to the simplicity of the technology-based interventions previously employed (i.e. text message-based systems). Advanced digital health interventions on blood pressure--namely remote blood pressure monitoring through Bluetooth-enabled blood pressure cuffs and incorporation of a commercially available smartphone application that includes education and patient support as part of a hypertension in pregnancy pathway-may more effectively improve perinatal health equity compared to standard SMS-based messaging by reducing perinatal morbidity/mortality among women of color hypertension during their pregnancy. The investigators propose a pilot randomized control trial to examine the feasibility, acceptability, and preliminary estimates of effects of smartphone application-based (app-based) Bluetooth enabled remote blood pressure monitoring (intervention group) when compared to a SMS (short message system such as text message) based remote blood pressure monitoring group (control group). The investigators' long-term goal is to use the most cost-effective intervention (app-based vs SMS-based remote blood pressure monitoring) to improve health equity and maternal morbidity outcomes for pregnant women with hypertension during pregnancy who live in Rhode Island and beyond. The investigators plan to use pilot data from this proposal to support an efficacy trial powered to detect differences in maternal morbidity outcomes between app-based remote blood pressure monitoring and routine care with SMS monitoring. In addition, this proposal stems from a hospital-wide effort at Women & Infants Hospital (WIH) to reduce racial disparities among women of color in terms of frequency of severe maternal morbidity (SMM). SMM is a metric created by the Centers for Disease Control and Prevention that includes blood transfusion as well as adverse outcomes ranging from arrhythmia to eclampsia to intubation. SMM associated with hypertension is driven by asymptomatic postpartum hypertension. This is easily identified and managed prior to becoming SMM when patients adhere to recommended blood pressure checks after discharge. Excluding blood transfusion (which does not pertain to hypertension), the overall rate of SMM among women with hypertension during pregnancy who deliver at WIH is 6.6%. However, there is a significant difference along racial and ethnic lines: the rate of SMM in the setting of hypertension among black women is 6.8% compared to 4.5% among white women, and the rate of SMM in the setting of preeclampsia is 9.4% among Hispanic women compared to 4.9% among non-Hispanic women. The overall dual aim of the initiative is to reduce the disparity in rates of SMM among those with hypertension between black and white women and between Hispanic and non-Hispanic women by at least 33% by December 31, 2022. As part of WIH's equity initiative, automatic blood pressure cuffs (non Bluetooth enabled) will be provided to consenting women with hypertension at discharge from delivery hospitalization as part of routine care. In this study, rates of SMM before the hospital-wide implementation of SMS-based remote blood pressure monitoring will be compared to those after. Thus, for this proposal, this proposal exploring whether app-based remote blood pressure monitoring is required to decrease maternal morbidity compared to standard care with remote SMS blood pressure monitoring.
Interventions
BEHAVIORALApp-based remote blood pressure monitoring
Fully synched bluetooth-enabled remote blood pressure monitoring using a smartphone application. The digital health company, Twistle, has modified an existing postpartum hypertension pathway in their app according to our hospital's management algorithm.
BEHAVIORALtext-message based remote blood pressure monitoring
Participants will receive automatic blood pressure cuffs and instructions as to how to upload their measurements to the Electronic Medical Record.
Sponsors
Women and Infants Hospital of Rhode Island
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Participants who consent will be unaware of the existence of the other remote blood pressure monitoring program. The nurse practitioner who manages postpartum hypertension for all participants will be aware of randomization group but will manage each participant per a standard treatment algorithm regardless of randomization group. The research team and outcomes assessors will be blinded to the randomization group.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* a) English- or Spanish-speaking * b) maternal age \>18 years old * c) smartphone ownership for remote blood pressure ascertainment * d) diagnosis of gestational hypertension, preeclampsia, or chronic hypertension at hospital discharge * e) plan to receive postpartum care at a Women & Infants Hospital (WIH)-affiliated clinic
Exclusion criteria
* a) fetal anomaly * b) prisoners * c) lack of smartphone * d) inability to consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure Ascertainment | 3-10 days postpartum | Number of participants who adhere to recommended blood pressure check after hospital discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postpartum Readmission for Hypertension or Preeclampsia | Within 30 days of hospital discharge, patient is readmitted for complications related to hypertension or preeclampsia | Readmission rate for HTN/preeclampsia |
| Adherence to Evidence-based Practice | From randomization until 6 weeks postpartum | Medication initiation/titration, postpartum blood pressure goal of \<150/100 |
| Postpartum Severe Maternal Morbidity Composite | From randomization until 6 weeks postpartum | Stroke, seizure/eclampsia, acute fatty liver of pregnancy, posterior reversible encephalopathy syndrome, pulmonary edema, heart failure, hemolysis elevated liver enzymes and low platelets, placental abruption, postpartum hemorrhage, acute kidney injury, transaminitis |
| Using Any Number From 0 to 10 Where 0 is the Worst Possible Experience and 10 is the Best Possible Experience, Please Rate Your Experience in the Postpartum Hypertension Program | Assessed at randomization and at 40 days postpartum, reported at 40 days postpartum | Patient preference of treatment group |
| Decisional Regret Scale | Assessed at randomization and at 40 days postpartum, reported at 40 days postpartum | Extent to which participant regrets participating in a treatment group. To help interpret the score more readily with other scales ranging from 0 to 100, these scores can then be converted to a 0-100 scale by subtracting 1 from each item then multiply by 25. To obtain a final score, the items are summed and averaged. A score of 0 means no regret; a score of 100 means high regret. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Text-message Based Remote Blood Pressure Monitoring Women in this group will receive current standard of care: remote blood pressure monitoring via text message. Specifically, they will receive automatic blood pressure cuffs, instructions how to obtain their blood pressures and log them into our Electronic Medical Record, and contact information for the nurse practitioner and community health worker managing the program. The NP will respond via text message to each individual measurement with instructions as to next steps.
text-message based remote blood pressure monitoring: Participants will receive automatic blood pressure cuffs and instructions as to how to upload their measurements to the Electronic Medical Record. | 60 |
| App-based Remote Blood Pressure Monitoring Women in this group will receive a Bluetooth-enabled automatic blood pressure cuff that synchs automatically to a smartphone application that incorporates Artificial Intelligence to respond to each recorded measurements with recommended next steps and also document the measurement and response in a secure platform. This affiliated smartphone application will also contain education on hypertension management. Upon receipt of the blood pressure cuff, participants will be instructed to set up the program/app.
App-based remote blood pressure monitoring: Fully synched bluetooth-enabled remote blood pressure monitoring using a smartphone application. The digital health company, Twistle, has modified an existing postpartum hypertension pathway in their app according to our hospital's management algorithm. | 59 |
| Total | 119 |
Baseline characteristics
| Characteristic | Total | Text-message Based Remote Blood Pressure Monitoring | App-based Remote Blood Pressure Monitoring |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 119 Participants | 60 Participants | 59 Participants |
| Age, Continuous | 32 years | 32 years | 31 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 21 Participants | 9 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 62 Participants | 34 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 36 Participants | 17 Participants | 19 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 11 Participants | 7 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 | 45 Participants | 20 Participants | 25 Participants |
| Race (NIH/OMB) White | 54 Participants | 27 Participants | 27 Participants |
| Region of Enrollment United States | 119 participants | 60 participants | 59 participants |
| Sex: Female, Male Female | 119 Participants | 60 Participants | 59 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 59 |
| other Total, other adverse events | 0 / 60 | 0 / 59 |
| serious Total, serious adverse events | 0 / 60 | 0 / 59 |
Outcome results
Primary
Blood Pressure Ascertainment
Number of participants who adhere to recommended blood pressure check after hospital discharge
Time frame: 3-10 days postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Text-message Based Remote Blood Pressure Monitoring | Blood Pressure Ascertainment | 40 Participants |
| App-based Remote Blood Pressure Monitoring | Blood Pressure Ascertainment | 39 Participants |
Secondary
Adherence to Evidence-based Practice
Medication initiation/titration, postpartum blood pressure goal of \<150/100
Time frame: From randomization until 6 weeks postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Text-message Based Remote Blood Pressure Monitoring | Adherence to Evidence-based Practice | 15 Participants |
| App-based Remote Blood Pressure Monitoring | Adherence to Evidence-based Practice | 16 Participants |
Secondary
Decisional Regret Scale
Extent to which participant regrets participating in a treatment group. To help interpret the score more readily with other scales ranging from 0 to 100, these scores can then be converted to a 0-100 scale by subtracting 1 from each item then multiply by 25. To obtain a final score, the items are summed and averaged. A score of 0 means no regret; a score of 100 means high regret.
Time frame: Assessed at randomization and at 40 days postpartum, reported at 40 days postpartum
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Text-message Based Remote Blood Pressure Monitoring | Decisional Regret Scale | 5 score on a scale |
| App-based Remote Blood Pressure Monitoring | Decisional Regret Scale | 0 score on a scale |
Secondary
Postpartum Readmission for Hypertension or Preeclampsia
Readmission rate for HTN/preeclampsia
Time frame: Within 30 days of hospital discharge, patient is readmitted for complications related to hypertension or preeclampsia
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Text-message Based Remote Blood Pressure Monitoring | Postpartum Readmission for Hypertension or Preeclampsia | 4 Participants |
| App-based Remote Blood Pressure Monitoring | Postpartum Readmission for Hypertension or Preeclampsia | 8 Participants |
Secondary
Postpartum Severe Maternal Morbidity Composite
Stroke, seizure/eclampsia, acute fatty liver of pregnancy, posterior reversible encephalopathy syndrome, pulmonary edema, heart failure, hemolysis elevated liver enzymes and low platelets, placental abruption, postpartum hemorrhage, acute kidney injury, transaminitis
Time frame: From randomization until 6 weeks postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Text-message Based Remote Blood Pressure Monitoring | Postpartum Severe Maternal Morbidity Composite | 0 Participants |
| App-based Remote Blood Pressure Monitoring | Postpartum Severe Maternal Morbidity Composite | 0 Participants |
Secondary
Using Any Number From 0 to 10 Where 0 is the Worst Possible Experience and 10 is the Best Possible Experience, Please Rate Your Experience in the Postpartum Hypertension Program
Patient preference of treatment group
Time frame: Assessed at randomization and at 40 days postpartum, reported at 40 days postpartum
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Text-message Based Remote Blood Pressure Monitoring | Using Any Number From 0 to 10 Where 0 is the Worst Possible Experience and 10 is the Best Possible Experience, Please Rate Your Experience in the Postpartum Hypertension Program | 10 score on a scale |
| App-based Remote Blood Pressure Monitoring | Using Any Number From 0 to 10 Where 0 is the Worst Possible Experience and 10 is the Best Possible Experience, Please Rate Your Experience in the Postpartum Hypertension Program | 10 score on a scale |