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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Text-message based remote blood pressure monitoring | Active Comparator | 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. |
|
| App-based remote blood pressure monitoring | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| App-based remote blood pressure monitoring | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure Ascertainment | Number of participants who adhere to recommended blood pressure check after hospital discharge | 3-10 days postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Postpartum Readmission for Hypertension or Preeclampsia | Readmission rate for HTN/preeclampsia | Within 30 days of hospital discharge, patient is readmitted for complications related to hypertension or preeclampsia |
| Adherence to Evidence-based Practice |
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Inclusion Criteria:
Exclusion Criteria:
Anyone who is postpartum--regardless of gender identity--will be eliglble to participate
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| Name | Affiliation | Role |
|---|---|---|
| Adam Lewkowitz, MD, MPHS | Women and Infants Hospital of Rhode Island | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women & Infants Hospital of Rhode Island | Providence | Rhode Island | 02905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38880206 | Derived | Lewkowitz AK, Baker R, Schlichting LE, Ware CF, Rousseau J, Miller ES, Hauspurg A, Rouse DJ, Richardson C, Gutman R, Tuuli MG. A pilot randomized trial of automatic, artificial intelligence-based vs manual, electronic medical record-based remote postpartum blood pressure monitoring. Am J Obstet Gynecol. 2024 Sep;231(3):358-360.e3. doi: 10.1016/j.ajog.2024.06.008. Epub 2024 Jun 14. No abstract available. | |
| 38810010 |
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Data from this small pilot will not be made available to other researchers.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Blood Pressure Ascertainment | Number of participants who adhere to recommended blood pressure check after hospital discharge | Posted | Count of Participants | Participants | 3-10 days postpartum |
|
Adverse data were collected from randomization until study completion (6 weeks postpartum)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adam Lewkowitz | Women & Infants Hospital of Rhode Island | 401-274-1122 | alewkowitz@kentri.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 17, 2023 | Dec 11, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011225 | Pre-Eclampsia |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D006973 | Hypertension |
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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.
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| text-message based remote blood pressure monitoring | Behavioral | Participants will receive automatic blood pressure cuffs and instructions as to how to upload their measurements to the Electronic Medical Record. |
|
Medication initiation/titration, postpartum blood pressure goal of <150/100 |
| From randomization until 6 weeks postpartum |
| 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 | From randomization until 6 weeks postpartum |
| "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 | Assessed at randomization and at 40 days postpartum, reported at 40 days postpartum |
| 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. | Assessed at randomization and at 40 days postpartum, reported at 40 days postpartum |
| Derived |
| Lewkowitz AK, Schlichting LE, Ayala NK, O'Neill A, McCleary KD, Hardy EJ, Hamel M, Tuuli MG. Association Between Hispanic Ethnicity and Engagement in a Remote Postpartum Blood Pressure Monitoring Programs: Secondary Analysis of a Pilot Randomized Trial. R I Med J (2013). 2024 Jun 3;107(6):17-18. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
|
|
| Secondary | Postpartum Readmission for Hypertension or Preeclampsia | Readmission rate for HTN/preeclampsia | Posted | Count of Participants | Participants | Within 30 days of hospital discharge, patient is readmitted for complications related to hypertension or preeclampsia |
|
|
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| Secondary | Adherence to Evidence-based Practice | Medication initiation/titration, postpartum blood pressure goal of <150/100 | Posted | Count of Participants | Participants | From randomization until 6 weeks postpartum |
|
|
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| 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 | Posted | Count of Participants | Participants | From randomization until 6 weeks postpartum |
|
|
|
| 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 | Posted | Median | Inter-Quartile Range | score on a scale | Assessed at randomization and at 40 days postpartum, reported at 40 days postpartum |
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|
|
| 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. | Posted | Median | Inter-Quartile Range | score on a scale | Assessed at randomization and at 40 days postpartum, reported at 40 days postpartum |
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | 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. | 0 | 59 | 0 | 59 | 0 | 59 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |