Reach Out: Emergency Department-Initiated Hypertension Behavioral Intervention Connecting Multiple Health Systems
ReachOut ED
Reach Out: Randomized Clinical Trial of Emergency Department-Initiated Hypertension Behavioral Intervention Connecting Multiple Health Systems
2 other identifiers
interventional
488
1 country
1
Brief Summary
This study evaluates a health theory based mobile health behavioral intervention to reduce blood pressure (BP) among hypertensive patients evaluated in a community Emergency Department (ED) setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hypertension
Started Mar 2019
Typical duration for not_applicable hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2018
CompletedFirst Posted
Study publicly available on registry
February 6, 2018
CompletedStudy Start
First participant enrolled
March 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 8, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 8, 2021
CompletedResults Posted
Study results publicly available
June 20, 2024
CompletedJune 20, 2024
May 1, 2024
2 years
January 30, 2018
November 15, 2023
May 23, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Mean Systolic Blood Pressure
Change in 12-month Systolic Blood Pressure (SBP)
12 months
Secondary Outcomes (2)
Hazard Ratio Analysis of Participant Time From Enrollment Emergency Department Visit to the First PCP Visit
Baseline ED visit (in days)
Odds Ratio Analysis of Participants Completing 2 or More Primary Care Visits
12 months
Study Arms (8)
Arm 1
EXPERIMENTALNo healthy behavior texts BP Monitoring Weekly Via Text Messaging No physician appointment and transportation scheduling
Arm 2
EXPERIMENTALHealthy Behavior Texts BP Monitoring Weekly Via Text Messaging No physician appointment and transportation scheduling
Arm 3
EXPERIMENTALNo healthy behavior texts BP Monitoring Daily Via Text Messaging No physician appointment and transportation scheduling
Arm 4
EXPERIMENTALHealthy Behavior Texts BP Monitoring Daily Via Text Messaging No physician appointment and transportation scheduling
Arm 5
EXPERIMENTALNo healthy behavior texts BP Monitoring Weekly Via Text Messaging Physician appointment and transportation scheduling
Arm 6
EXPERIMENTALHealthy Behavior Texts BP Monitoring Weekly Via Text Messaging Physician appointment and transportation scheduling
Arm 7
EXPERIMENTALNo healthy behavior texts BP Monitoring Daily Via Text Messaging Physician appointment and transportation scheduling
Arm 8
EXPERIMENTALHealthy Behavior Texts BP Monitoring Daily Via Text Messaging Physician appointment and transportation scheduling
Interventions
Participants receive motivational health behavior texts
Participants do not receive healthy behavior texts
Daily text messages will prompt participants for BP by home cuff
Weekly text messages will prompt participants for BP by home cuff
Participants receive assistance scheduling physician appointment and transportation to those appointments
Participants do not receive assistance scheduling physician appointment or transportation
Eligibility Criteria
You may qualify if:
- Age of 18 or greater
- 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
You may not qualify if:
- Unable to read English (\<1% at study site)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hurley Medical Center
Flint, Michigan, 48503, United States
Related Publications (4)
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.
PMID: 38805251DERIVEDSkolarus 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.
PMID: 37192282DERIVEDSkolarus 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.
PMID: 34819115DERIVEDMeurer 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.
PMID: 32493502DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Principal Investigator
- Organization
- University of Michigan
Study Officials
- PRINCIPAL INVESTIGATOR
William Meurer, MD
University of Michigan
- PRINCIPAL INVESTIGATOR
Lesli Skolarus, MD
University of Michigan
- STUDY DIRECTOR
Mackenzie Dinh, MS
University of Michigan
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Emergency Medicine
Study Record Dates
First Submitted
January 30, 2018
First Posted
February 6, 2018
Study Start
March 25, 2019
Primary Completion
April 8, 2021
Study Completion
April 8, 2021
Last Updated
June 20, 2024
Results First Posted
June 20, 2024
Record last verified: 2024-05