An interventional study of Implementation Intervention in Alcohol Drinking, sponsored by UConn Health. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by UConn Health · Not applicable, Interventional, and Health services research
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.
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.
925 studies on the registry are indexed under Alcohol Drinking; 172 are open to participants now.
This study's enrollment of 228 is above the median of 108 across 802 interventional studies indexed under Alcohol Drinking.
Browse Alcohol Drinking studies →UConn Health is the lead sponsor of 182 studies on the registry; 18 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
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Patient Inclusion Criteria
Staff Inclusion Criteria:
Exclusion Criteria: None
Through virtual and in-person meetings, the internal/external facilitation team will support sites in utilizing the multi-component implementation strategy for 7 months
Other: Implementation 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.
Virtual and in-person implementation support
Implementation Effectiveness
The proportion of eligible patients who enrolled in the alcohol text messaging intervention in the implementation intervention and the control condition.
Time frame: 5-month intervention period and subsequent sustainability period
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.
Time frame: 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.
Time frame: 6-months post-intervention
Units of randomization were emergency departments. Two emergency departments were assigned to the Implementation Intervention Condition, and 2 to the Implementation as Usual Condition for a total of 4 emergency departments. Within the Implementation Intervention condition emergency department sites, staff and patients were surveyed and demographics were collected. Within the Implementation as Usual condition emergency departments sites, data was only collected for patients.
| Milestone | Implementation Intervention | Implementation as Usual |
|---|---|---|
| Started | 217 | 11 |
| Staff started | 119 | 0 |
| Patients started | 98 | 11 |
| Staff completed | 119 | 0 |
| Patients completed | 98 | 0 |
| Completed | 217 | 11 |
| Not completed | 0 | 0 |
The proportion of eligible patients who enrolled in the alcohol text messaging intervention in the implementation intervention and the control condition.
| Participants | Implementation Intervention | Implementation as Usual |
|---|---|---|
| Implementation Effectiveness | 42 | 11 |
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.
| score on a Likert scale | Implementation Intervention: Patients | Implementation Intervention: Staff |
|---|---|---|
| Implementation Feasibility Using the Feasibility of Intervention Measure (FIM) | 4.30 ± .95 | 3.89 ± .85 |
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.
| score on a Likert scale | Implementation Intervention: Patients | Implementation Intervention: Staff |
|---|---|---|
| Implementation Acceptability Using the Acceptability of Intervention Measure (AIM) | 4.35 ± .63 | 4.06 ± .71 |
Collected over 7 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Implementation Intervention | 0/217 (0%) | 0/217 (0%) | 0/217 (0%) |
| Implementation as Usual | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
Data was missing for several baseline demographic items, which is why the baseline number of participants was different than the assignment in the participant flow.
| Age, Continuous(Years) | Implementation Intervention: Patients | Implementation as Usual: Patients | Implementation Intervention: Staff | Total |
|---|---|---|---|---|
| Mean | 37.61 (21 to 70) | 33.8 (21 to 60) | 39.96 (18 to 62) | 39.34 (18 to 70) |
| Sex: Female, Male(Participants) | Implementation Intervention: Patients | Implementation as Usual: Patients | Implementation Intervention: Staff | Total |
|---|---|---|---|---|
| Female | 34 | 5 | 77 | 116 |
| Male | 34 | 6 | 31 | 71 |
| Race (NIH/OMB)(Participants) | Implementation Intervention: Patients | Implementation as Usual: Patients | Implementation Intervention: Staff | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 2 | 0 | 0 | 2 |
| Asian | 1 | 0 | 8 | 9 |
| Native Hawaiian or Other Pacific Islander | 3 | 0 | 0 | 3 |
| Black or African American | 14 | 0 | 32 | 46 |
| White | 44 | 6 | 54 | 104 |
| More than one race | 2 | 0 | 10 | 12 |
| Unknown or Not Reported | 32 | 5 | 15 | 52 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Individual participant data will be shared in the NIAAA Data Archive
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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