EMPOWER: Effects of Monitoring blood Pressure Of pregnant Women Electronically and Remotely

Last registered on May 22, 2023
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Pre-Trial

Trial Information

General Information

Title
EMPOWER: Effects of Monitoring blood Pressure Of pregnant Women Electronically and Remotely
RCT ID
AEARCTR-0010678
Initial registration date
December 20, 2022

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
January 03, 2023, 4:58 PM EST

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Last updated
May 22, 2023, 8:30 PM EDT

Last updated is the most recent time when changes to the trial's registration were published.

Locations

Country
United States of America
Region
Missouri

Primary Investigator

Name
Matthew Notowidigdo
Affiliation
University of Chicago Booth School of Business
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Other Primary Investigator(s)

PI Name
Sanjog Misra
PI Affiliation
University of Chicago
Contact Investigator
PI Name
Marcella Alsan
PI Affiliation
Harvard University
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Additional Trial Information

Status
On going
Start date
2022-10-01
End date
2023-12-01
Keywords
Behavior, Gender, Health
Additional Keywords
JEL code(s)
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
Despite advancing medical technologies, severe maternal morbidity has increased by about 200 percent over the past few decades (CDC 2021). A recent study found that 4 out of 5 pregnancy-related deaths are preventable. A common cause of maternal mortality is preeclampsia – a dangerous pregnancy and postpartum complication associated with high blood pressure which can result in seizure, organ damage, or stroke. It affects about 1 in 25 pregnant women and causes 15 percent of premature births (CDC 2021). Several interventions have aimed to mitigate the devastating effects of preeclampsia, including the distribution of self-monitoring blood pressure (SMBP) cuffs. Distributing SMBP cuffs may allow for the early detection of possible increases in blood pressure and give women agency within their own health care decisions.

We propose to randomize the distribution of 4500 self-monitoring blood pressure cuffs (SMBP)- across prenatal facilities in the state of Missouri. Using Medicaid data, provider-level surveys, and individual-level SMS surveys, we will assess the impact that the distribution of SMBPs has on the detection and management of hypertensive disorders of pregnancy, feelings of empowerment during the prenatal and postpartum periods for vulnerable women, and the detection or management of high blood pressure in other household members through spillover effects.
External Link(s)

Registration Citation

Citation
Alsan, Marcella , Sanjog Misra and Matthew Notowidigdo. 2023. "EMPOWER: Effects of Monitoring blood Pressure Of pregnant Women Electronically and Remotely." AEA RCT Registry. May 22. https://doi.org/10.1257/rct.10678-2.0
Sponsors & Partners

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Experimental Details

Interventions

Intervention(s)
We propose to randomize the distribution of 4500 self-monitoring blood pressure cuffs (SMBP)- across prenatal facilities in the state of Missouri. We hypothesize that the distribution of SMBPs will increase detection and management of hypertensive disorders of pregnancy, increase feelings of empowerment during the prenatal and postpartum periods for vulnerable women, and increase the detection or management of high blood pressure in other household members through spillover effects.

Using medicaid data, provider-level surveys, and individual-level SMS surveys we plan to assess a variety of administrative and survey outcomes ranging from admittance to the prenatal ward to feelings of agency in healthcare related decisions.
Intervention Start Date
2022-10-01
Intervention End Date
2023-12-01

Primary Outcomes

Primary Outcomes (end points)
Our primary administrative data outcomes include: (1) Detection of pregnancy-related hypertension, (2) Number of visits to prenatal providers, (3) Prescription of anti-hypertensive and other management medications, (4) Admittance to the prenatal ward, (5) Complications at delivery, (6) Attendance of postpartum check-up.

Our primary survey data outcomes include: (1) General demographics, (2) Feelings of agency in healthcare decisions, (3) Satisfaction with healthcare services/treatment
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
Secondary Administrative Data Outcomes: (1) Detection of hypertension in household members, (2) Infant mortality, (3) Infant morbidity
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
The analysis will compare outcomes for those who were randomized to receive the intervention to those who were randomized to the control group. We will estimate the intent-to-treat effect using ordinary least squares estimation in a difference-in-difference methodology.
Experimental Design Details
Randomization Method
Randomization method utilized in this study is a stratified cluster method. We stratified based on clinic size (number of annual births). The randomization was completed via STATA.
Randomization Unit
The unit of randomization is clinic-level.
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
53 clinics
Sample size: planned number of observations
10,000 patients across 53 clusters.
Sample size (or number of clusters) by treatment arms
22 clinics in the control group and 31 in the treatment group
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Supporting Documents and Materials
IRB

Institutional Review Boards (IRBs)

IRB Name
University of Chicago
IRB Approval Date
2022-12-18
IRB Approval Number
IRB22-1499
Analysis Plan

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Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials