Alcohol DrinkingNCT05350878
Implementing Mobile Technology for Unhealthy Alcohol Use
A study testing Implementation Intervention in people with Alcohol Drinking, run by UConn Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Drinking
- What is being tested?
- Implementation Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2023to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Alcohol Drinking
- Being tested
- Implementation Intervention
- Keywords
- Implementation Science, Text Messaging, Unhealthy Alcohol Use, Mobile Health, mHealth
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation InterventionOther
Virtual and in-person implementation support
| Study group | Role | What they receive |
|---|---|---|
| Implementation Intervention | Experimental | Through virtual and in-person meetings, the internal/external facilitation team will support sites in utilizing the multi-component implementation strategy for 7 months Receives: Other: Implementation Intervention |
| Implementation as Usual | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Implementation Effectiveness
The proportion of eligible patients who enrolled in the alcohol text messaging intervention in the implementation intervention and the control condition.
Measured: 5-month intervention period and subsequent sustainability period
Secondary outcomes (2)
Implementation Feasibility Using the Feasibility of Intervention Measure (FIM)
Feasibility of text messaging implementation strategy using the Feasibility of Intervention Measure (FIM). Measures the extent to which an intervention can be successfully used or implemented in a given context. 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree. Higher scores indicate better feasibility.
Measured: 6-months post-intervention
Implementation Acceptability Using the Acceptability of Intervention Measure (AIM)
Acceptability of text messaging implementation strategy; AIM (Acceptability of Intervention Measure) evaluates how agreeable, palatable, or satisfactory an intervention is to stakeholders. Response Scale: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree. Higher scores indicate better acceptability.
Measured: 6-months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start1 Oct 2023
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Cluster Randomized
- Masking
- None (open label)
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- Northwell Health, Partnership to End Addiction, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Megan O'Grady, UConn Health
- Investigators
- Megan A O'Grady, PhD, Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05350878
- Sponsor's protocol ID
- O22-184-1
- Other IDs
- R21AA029734
- Status last verified
- Aug 2026
- First submitted
- 18 Apr 2022
- Last updated
- 7 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be shared in the NIAAA Data Archive
Publications
O'Grady MA, Kapoor S, Harrison L, Kwon N, Suleiman AO, Muench FJ. Implementing a text-messaging intervention for unhealthy alcohol use in emergency departments: protocol for implementation strategy development and a pilot cluster randomized implementation trial. Implement Sci Commun. 2022 Aug 6;3(1):86. doi: 10.1186/s43058-022-00333-y.
PubMed 35933560
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Mobile Technology for Unhealthy Alcohol Use in Emergency Departments
- ClinicalTrials.gov ID
- NCT05350878
- Acronym / sponsor ID
- O22-184-1
- Conditions
- Alcohol Drinking
- Keywords
- Implementation Science, Text Messaging, Unhealthy Alcohol Use, Mobile Health, mHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- Northwell Health, Partnership to End Addiction, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 28 Apr 2022 (actual)
- Results
- Posted 7 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Cluster Randomized
| Arm | Type | Receives |
|---|---|---|
| Implementation Intervention | Experimental | Other: Implementation InterventionThrough virtual and in-person meetings, the internal/external facilitation team will support sites in utilizing the multi-component implementation strategy for 7 months |
| Implementation as Usual | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation InterventionVirtual and in-person implementation support | Other | Implementation Intervention |
Primary outcome
Implementation Effectiveness
Time frame: 5-month intervention period and subsequent sustainability period
The proportion of eligible patients who enrolled in the alcohol text messaging intervention in the implementation intervention and the control condition.
2 secondary outcomes
Implementation Feasibility Using the Feasibility of Intervention Measure (FIM)
Time frame: 6-months post-intervention
Implementation Acceptability Using the Acceptability of Intervention Measure (AIM)
Time frame: 6-months post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35933560O'Grady MA, Kapoor S, Harrison L, Kwon N, Suleiman AO, Muench FJ. Implementing a text-messaging intervention for unhealthy alcohol use in emergency departments: protocol for implementation strategy development and a pilot cluster randomized implementation trial. Implement Sci Commun. 2022 Aug 6;3(1):86. doi: 10.1186/s43058-022-00333-y.
- Individual participant dataSharing planned: Yes. Individual participant data will be shared in the NIAAA Data Archive
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan A O'Grady, PhD principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation Intervention in people with Alcohol Drinking, run by UConn Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implementation Effectiveness (time frame: 5-month intervention period and subsequent sustainability period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05350878, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.