- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05350878
Implementing Mobile Technology for Unhealthy Alcohol Use
August 28, 2025 updated by: Megan O'Grady, UConn Health
Implementing Mobile Technology for Unhealthy Alcohol Use in Emergency Departments
Scalable approaches are needed to support patients identified in the emergency department as unhealthy alcohol users and text messaging intervention approaches are a promising solution.
However, the process of providers making text messing interventions for unhealthy alcohol use available to patients in an efficient way within already busy and overburdened emergency department workflows (i.e., implementation in real-world emergency department settings) and patients adopting them remains a new area of research.
Study investigators will examine barriers and facilitators to the adoption of text messaging interventions for unhealthy alcohol use in emergency departments and use a stakeholder-engaged process to develop and test practical implementation strategies that could provide much needed support to patients who screen positive while reducing burden on emergency departments.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Unhealthy alcohol use (UAU) is one of the leading causes of premature mortality among adults in the United States and has been increasing during the COVID-19 pandemic.
UAU is more frequent among emergency department (ED) patients than in the general population and ED visits involving alcohol consumption have increased in recent years.
Substance use has been described as the most important modifiable health behavior in the ED, and the ED has been highlighted as a key setting to intervene with UAU individuals.
Consequently, health systems across the country need low burden, scalable ways to intervene with individuals but often have limited time and resources.
Mobile technologies have been suggested as a solution to assist EDs in addressing UAU and one of the lowest burden, scalable approaches are text messaging interventions.
Text messaging interventions for ED and trauma patients and other populations have shown good outcomes, including reductions in drinking quantity and frequency.
Despite strong research support and promise for scalability, there is little evidence that technology-based behavioral health interventions can be effectively implemented into healthcare settings.
There are few studies in which technology interventions for behavioral health are put into real world healthcare settings; those that have been conducted show that the benefits seen in randomized trials are often not realized.
While EDs are promising venues for addressing UAU using text messaging interventions, the process of providers making them available to patients in an efficient way within already busy and overburdened ED workflows (i.e., implementation in real-world ED settings) and patients adopting them remains a new area of research.
This proposal builds on the longstanding collaboration of our interdisciplinary team on the implementation of substance use screening and brief interventions in healthcare settings.
In response to the NIH Notice of Special Interest for Research in the Emergency Setting, the investigators propose to examine potential barriers and facilitators to staff offering and patients accepting a text messaging intervention in the ED.
The investigators will then use a stakeholder-engaged Intervention Mapping process to develop a multi-component implementation strategy for EDs.
Finally, the investigators will conduct a mixed method 2-arm cluster-randomized pilot study in 4 EDs that serve ~13,000 UAU patients per year to assess the feasibility, acceptability and preliminary effectiveness of the implementation strategy.
The Integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework will guide study activities.
Low burden technology, like text messaging, along with targeted implementation support and strategies driven by identified barriers and facilitators could sustain large-scale ED-based alcohol screening programs and provide much needed support to patients who screen positive while reducing burden on EDs.
The proposed study would be the first to develop and test this targeted implementation strategy.
This 2-year R21 will prepare for a future, larger, fully-powered hybrid effectiveness-implementation trial.
Study Type
Interventional
Enrollment (Actual)
344
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
-
New Hyde Park, New York, United States, 11040
- Northwell Health
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Patient Inclusion Criteria
- Emergency department patient at one of the participating sites
- 18 years or older
- English-language fluency
- Owing a text-capable phone
Staff Inclusion Criteria:
- Emergency department staff and providers who work in the intervention sites
- Employed full or part time by the participating health system
Exclusion Criteria: None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Implementation Intervention
Through virtual and in-person meetings, the internal/external facilitation team will support sites in utilizing the multi-component implementation strategy for 7 months
|
Virtual and in-person implementation support
|
|
No Intervention: Implementation as Usual
In control 'implementation as usual' sites, no facilitation or implementation strategies will be provided.
Controls will receive 1) an informational session on the text intervention during grand rounds/staff meetings and 2) flyers to provide patients with intervention enrollment information.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Implementation Effectiveness
Time Frame: 5-month intervention period
|
The proportion of eligible patients who enroll in the alcohol text messaging intervention
|
5-month intervention period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Implementation Feasibility using the Feasibility of Intervention Measure (FIM)
Time Frame: 6-months post-intervention
|
Feasibility of text messaging implementation strategy
|
6-months post-intervention
|
|
Implementation Acceptability using the Acceptability of Intervention Measure (AIM)
Time Frame: 6-months post-intervention
|
Acceptability of text messaging implementation strategy
|
6-months post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Megan A O'Grady, PhD, UConn Health
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2023
Primary Completion (Actual)
December 1, 2024
Study Completion (Actual)
December 1, 2024
Study Registration Dates
First Submitted
April 18, 2022
First Submitted That Met QC Criteria
April 22, 2022
First Posted (Actual)
April 28, 2022
Study Record Updates
Last Update Posted (Estimated)
September 5, 2025
Last Update Submitted That Met QC Criteria
August 28, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- O22-184-1
- R21AA029734 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Individual participant data will be shared in the NIAAA Data Archive
IPD Sharing Time Frame
Data will be available at the end of the study
IPD Sharing Access Criteria
Per NIAAA archive access criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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