NCT05350878

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
344

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
completed

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

April 18, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 28, 2022

Completed
1.4 years until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

September 5, 2025

Status Verified

March 1, 2025

Enrollment Period

1.2 years

First QC Date

April 18, 2022

Last Update Submit

August 28, 2025

Conditions

Keywords

Implementation ScienceText MessagingUnhealthy Alcohol UseMobile HealthmHealth

Outcome Measures

Primary Outcomes (1)

  • Implementation Effectiveness

    The proportion of eligible patients who enroll in the alcohol text messaging intervention

    5-month intervention period

Secondary Outcomes (2)

  • Implementation Feasibility using the Feasibility of Intervention Measure (FIM)

    6-months post-intervention

  • Implementation Acceptability using the Acceptability of Intervention Measure (AIM)

    6-months post-intervention

Study Arms (2)

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

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.

Interventions

Virtual and in-person implementation support

Implementation Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Emergency department patient at one of the participating sites
  • years or older
  • English-language fluency
  • Owing a text-capable phone
  • Emergency department staff and providers who work in the intervention sites
  • Employed full or part time by the participating health system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwell Health

New Hyde Park, New York, 11040, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Study Officials

  • Megan A O'Grady, PhD

    UConn Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Parallel Cluster Randomized
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 18, 2022

First Posted

April 28, 2022

Study Start

October 1, 2023

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

September 5, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

Individual participant data will be shared in the NIAAA Data Archive

Time Frame
Data will be available at the end of the study
Access Criteria
Per NIAAA archive access criteria
More information

Locations