Reach Out: Emergency Department-Initiated Hypertension Behavioral Intervention Connecting Multiple Health Systems
NCT ID: NCT03422718
Last Updated: 2024-06-20
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
488 participants
INTERVENTIONAL
2019-03-25
2021-04-08
Brief Summary
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Detailed Description
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The Emergency Department (ED) represents a missed opportunity to identify and treat hypertension in difficult-to-reach populations. Currently, there are 136 million ED visits per year and nearly all have at least one blood pressure measured and recorded. African Americans and socioeconomically disadvantaged patients are disproportionally represented in the ED patient population and both are increasing. In the age of electronic health records and mobile health, the ED can feasibly become an integral partner in chronic disease management by programming the electronic health record to identify hypertensive patients and dispense a mobile health behavioral intervention. Facilitating ED follow up at primary care clinics is a key feature of the proposed intervention. Thereby leveraging the strengths of the ED and its large patient volume of uncontrolled, difficult-to-reach, hypertensive patients, with the strengths of the primary care clinics, continuity of care is the key to improving community wide utilization of health services and receipt of guideline concordant medical care.
This study looks to determine which behavioral intervention components best contribute to a reduction in systolic blood pressure at one year through a multi-component theory based mobile health behavioral intervention.
Sample Size and Population
We originally planned to enroll approximately 960 patients into the eligibility phase. From this group, we estimate that 480 participants will report qualifying BPs and will be randomized to one of the eight intervention arms. We anticipate 240 participants will fully complete the 12 month, in person follow up visits. However, after accruing approximately 400 randomized participants, we noted lower than expected retention at 6 month visits. Therefore, we adjusted the maximum total number of enrollments and randomizations upwards by 50% each. The overall intention is to achieve approximately 240 protocol completers (attendees at 12-month visit). We will continue to monitor accrual and retention in order to achieve this target.
Data Analysis
The primary analysis will fit a linear regression model with the outcome of SBP change (baseline minus 12 months) and main effect-coded binary predictors of healthy behavior texts (yes vs. no), prompted BP self-monitoring frequency (high vs. low), and primary care provider visit scheduling and transportation (active vs. passive). Initial analyses will focus on the main effects. Additional analyses will include all the two-way interactions of the three intervention components (only considering interactions where at least one of the factors in the interaction demonstrates a sufficiently large main effect).
The main secondary analyses will use time-to event (Cox Proportional Hazards) and logistic regression. For the endpoint of interest, (either time to first primary care visit, or the binary variable indicating attendance at two or more primary care visits within 1 year of randomization), the investigators will fit an adjusted regression model.
Extension Study:
Reach Out Cognition which will extend Reach Out data collection past the current 12 months to 15 and 18 months. During Reach Out Cognition, we aim to assess novel approaches to mobile health (mHealth) self-administered cognition and blood pressure (BP) measurements. These approaches may include cognitive assessments via mobile applications (apps) and Web-based surveys, and wireless BP measurements via Bluetooth-enabled blood pressure cuffs and apps.
The study population for Reach Out Cognition will be drawn from Reach Out participants who complete the Reach Out intervention and are defined as: participants who complete the 12-month outcome assessment. We anticipate about 240 participants will have completed Reach Out's 12-month outcome assessment and will be eligible for Reach Out Cognition.
Descriptive statistics will be used to evaluate acceptability, feasibility and satisfaction. The de-nominator is the number of Reach Out participants who complete the 12 month assessments. Regarding feasibility, we will separately determine the feasibility by mHealth measure (i.e. cognition vs. BP), phone type (i.e. smartphone vs. feature phone) and operating system type (iOS vs. Android vs. Windows) as a continuous and dichotomous (\>50% completion of each assessment type) measure. The satisfaction scale will be assessed for all participants. Given the difference in procedures by phone type, we will compare satisfaction between the smartphone and feature phone users using a Kruskal-Wallis test.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Arm 1
No healthy behavior texts BP Monitoring Weekly Via Text Messaging No physician appointment and transportation scheduling
No healthy behavior texts
Participants do not receive healthy behavior texts
BP Monitoring Weekly Via Text Messaging
Weekly text messages will prompt participants for BP by home cuff
No physician appointment and transportation scheduling
Participants do not receive assistance scheduling physician appointment or transportation
Arm 2
Healthy Behavior Texts BP Monitoring Weekly Via Text Messaging No physician appointment and transportation scheduling
Healthy Behavior Texts
Participants receive motivational health behavior texts
BP Monitoring Weekly Via Text Messaging
Weekly text messages will prompt participants for BP by home cuff
No physician appointment and transportation scheduling
Participants do not receive assistance scheduling physician appointment or transportation
Arm 3
No healthy behavior texts BP Monitoring Daily Via Text Messaging No physician appointment and transportation scheduling
No healthy behavior texts
Participants do not receive healthy behavior texts
BP Monitoring Daily Via Text Messaging
Daily text messages will prompt participants for BP by home cuff
No physician appointment and transportation scheduling
Participants do not receive assistance scheduling physician appointment or transportation
Arm 4
Healthy Behavior Texts BP Monitoring Daily Via Text Messaging No physician appointment and transportation scheduling
Healthy Behavior Texts
Participants receive motivational health behavior texts
BP Monitoring Daily Via Text Messaging
Daily text messages will prompt participants for BP by home cuff
No physician appointment and transportation scheduling
Participants do not receive assistance scheduling physician appointment or transportation
Arm 5
No healthy behavior texts BP Monitoring Weekly Via Text Messaging Physician appointment and transportation scheduling
No healthy behavior texts
Participants do not receive healthy behavior texts
BP Monitoring Weekly Via Text Messaging
Weekly text messages will prompt participants for BP by home cuff
Physician appointment and transportation scheduling
Participants receive assistance scheduling physician appointment and transportation to those appointments
Arm 6
Healthy Behavior Texts BP Monitoring Weekly Via Text Messaging Physician appointment and transportation scheduling
Healthy Behavior Texts
Participants receive motivational health behavior texts
BP Monitoring Weekly Via Text Messaging
Weekly text messages will prompt participants for BP by home cuff
Physician appointment and transportation scheduling
Participants receive assistance scheduling physician appointment and transportation to those appointments
Arm 7
No healthy behavior texts BP Monitoring Daily Via Text Messaging Physician appointment and transportation scheduling
No healthy behavior texts
Participants do not receive healthy behavior texts
BP Monitoring Daily Via Text Messaging
Daily text messages will prompt participants for BP by home cuff
Physician appointment and transportation scheduling
Participants receive assistance scheduling physician appointment and transportation to those appointments
Arm 8
Healthy Behavior Texts BP Monitoring Daily Via Text Messaging Physician appointment and transportation scheduling
Healthy Behavior Texts
Participants receive motivational health behavior texts
BP Monitoring Daily Via Text Messaging
Daily text messages will prompt participants for BP by home cuff
Physician appointment and transportation scheduling
Participants receive assistance scheduling physician appointment and transportation to those appointments
Interventions
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Healthy Behavior Texts
Participants receive motivational health behavior texts
No healthy behavior texts
Participants do not receive healthy behavior texts
BP Monitoring Daily Via Text Messaging
Daily text messages will prompt participants for BP by home cuff
BP Monitoring Weekly Via Text Messaging
Weekly text messages will prompt participants for BP by home cuff
Physician appointment and transportation scheduling
Participants receive assistance scheduling physician appointment and transportation to those appointments
No physician appointment and transportation scheduling
Participants do not receive assistance scheduling physician appointment or transportation
Eligibility Criteria
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Inclusion Criteria
* At least one BP with Systolic Blood Pressure (SBP) ≥ 160 or a Diastolic Blood Pressure (DBP) ≥ 100 (criteria 1)
* If the patient has repeated measurements after achieving Criteria 1, at least one of the repeat BP remains SBP ≥ 140 or a DBP ≥ 90
* Must have cell phones with text-messaging capability and willingness to receive texts
* Likely to be discharged from the ED
Exclusion Criteria
* Prisoners
* Pregnant
* Pre-existing condition making one year follow-up unlikely
* Terminal illness with death expected within 90 days
* Current use of 3 or more antihypertensive agents
* Patients with other serious medical conditions that prevent self-monitoring of BP
* Critical illness with placement in resuscitation bay
* Dementia/cognitive impairment
18 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Institute on Minority Health and Health Disparities (NIMHD)
NIH
University of Michigan
OTHER
Responsible Party
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William J Meurer
Associate Professor of Emergency Medicine
Principal Investigators
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William Meurer, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Lesli Skolarus, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Mackenzie Dinh, MS
Role: STUDY_DIRECTOR
University of Michigan
Locations
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Hurley Medical Center
Flint, Michigan, United States
Countries
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References
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Dinh M, Lin CC, Whitfield C, Farhan Z, Meurer WJ, Bailey S, Skolarus LE. Exploring the Acceptability and Feasibility of Remote Blood Pressure Measurements and Cognition Assessments Among Participants Recruited From a Safety-Net Emergency Department (Reach Out Cognition): Nonrandomized Mobile Health Trial. JMIR Form Res. 2024 May 28;8:e54010. doi: 10.2196/54010.
Skolarus LE, Dinh M, Kidwell KM, Lin CC, Buis LR, Brown DL, Oteng R, Giacalone M, Warden K, Trimble DE, Whitfield C, Farhan Z, Flood A, Borgialli D, Montas S, Jaggi M, Meurer WJ. Reach Out Emergency Department: A Randomized Factorial Trial to Determine the Optimal Mobile Health Components to Reduce Blood Pressure. Circ Cardiovasc Qual Outcomes. 2023 May;16(5):e009606. doi: 10.1161/CIRCOUTCOMES.122.009606. Epub 2023 May 16.
Skolarus LE, Dinh M, Kidwell KM, Farhan Z, Whitfield C, Levine DA, Meurer WJ. Supplement study update for Reach Out: a multi-arm randomized trial of behavioral interventions for hypertension initiated in the emergency department: Reach Out Cognition. Trials. 2021 Nov 24;22(1):836. doi: 10.1186/s13063-021-05806-4.
Meurer WJ, Dinh M, Kidwell KM, Flood A, Champoux E, Whitfield C, Trimble D, Cowdery J, Borgialli D, Montas S, Cunningham R, Buis LR, Brown D, Skolarus L. Reach out behavioral intervention for hypertension initiated in the emergency department connecting multiple health systems: study protocol for a randomized control trial. Trials. 2020 Jun 3;21(1):456. doi: 10.1186/s13063-020-04340-z.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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HUM00138470
Identifier Type: -
Identifier Source: org_study_id
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