Trial Outcomes & Findings for Implementing Mobile Technology for Unhealthy Alcohol Use (NCT NCT05350878)
NCT ID: NCT05350878
Last Updated: 2026-08-07
Results Overview
The proportion of eligible patients who enrolled in the alcohol text messaging intervention in the implementation intervention and the control condition.
COMPLETED
NA
228 participants
5-month intervention period and subsequent sustainability period
2026-08-07
Participant Flow
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.
Unit of analysis: Emergency Departments
Participant milestones
| Measure |
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
Implementation Intervention: Virtual and in-person implementation support
|
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.
|
|---|---|---|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
|
Overall Study
STARTED
|
217 2
|
11 2
|
|
Overall Study
Staff Started
|
119 2
|
0 0
|
|
Overall Study
Patients Started
|
98 2
|
11 2
|
|
Overall Study
Staff completed
|
119 2
|
0 0
|
|
Overall Study
Patients Completed
|
98 2
|
0 0
|
|
Overall Study
COMPLETED
|
217 2
|
11 2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
There was missing data for 34 patients and 15 staff
Baseline characteristics by cohort
| Measure |
Implementation Intervention: Patients
n=98 Participants
Through virtual and in-person meetings, the internal/external facilitation team will support sites in utilizing the multi-component implementation strategy for 7 months
Implementation Intervention: Virtual and in-person implementation support
|
Implementation as Usual: Patients
n=11 Participants
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.
|
Implementation Intervention: Staff
n=119 Participants
Through virtual and in-person meetings, the internal/external facilitation team will support sites in utilizing the multi-component implementation strategy for 7 months
Implementation Intervention: Virtual and in-person implementation support
|
Total
n=228 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=98 Participants
|
0 Participants
n=11 Participants
|
8 Participants
n=119 Participants
|
9 Participants
n=228 Participants
|
|
Age, Continuous
|
37.61 Years
n=64 Participants • There was missing data for 34 patients and 15 staff
|
33.8 Years
n=11 Participants • There was missing data for 34 patients and 15 staff
|
39.96 Years
n=104 Participants • There was missing data for 34 patients and 15 staff
|
39.34 Years
n=179 Participants • There was missing data for 34 patients and 15 staff
|
|
Sex: Female, Male
Female
|
34 Participants
n=68 Participants • There was missing data for 30 patients and 11 staff
|
5 Participants
n=11 Participants • There was missing data for 30 patients and 11 staff
|
77 Participants
n=108 Participants • There was missing data for 30 patients and 11 staff
|
116 Participants
n=187 Participants • There was missing data for 30 patients and 11 staff
|
|
Sex: Female, Male
Male
|
34 Participants
n=68 Participants • There was missing data for 30 patients and 11 staff
|
6 Participants
n=11 Participants • There was missing data for 30 patients and 11 staff
|
31 Participants
n=108 Participants • There was missing data for 30 patients and 11 staff
|
71 Participants
n=187 Participants • There was missing data for 30 patients and 11 staff
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=98 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=119 Participants
|
2 Participants
n=228 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=98 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=119 Participants
|
3 Participants
n=228 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=98 Participants
|
0 Participants
n=11 Participants
|
32 Participants
n=119 Participants
|
46 Participants
n=228 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=98 Participants
|
6 Participants
n=11 Participants
|
54 Participants
n=119 Participants
|
104 Participants
n=228 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=98 Participants
|
0 Participants
n=11 Participants
|
10 Participants
n=119 Participants
|
12 Participants
n=228 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
32 Participants
n=98 Participants
|
5 Participants
n=11 Participants
|
15 Participants
n=119 Participants
|
52 Participants
n=228 Participants
|
PRIMARY outcome
Timeframe: 5-month intervention period and subsequent sustainability periodPopulation: In the 2 implementation intervention emergency department sites, 4200 patients were eligible for the text messaging program and of those, 42 enrolled (1%). In the control sites, of 11,0000 patients that were eligible for the text messaging intervention, 11 enrolled (.1%)
The proportion of eligible patients who enrolled in the alcohol text messaging intervention in the implementation intervention and the control condition.
Outcome measures
| Measure |
Implementation Intervention
n=4200 Participants
Through virtual and in-person meetings, the internal/external facilitation team will support sites in utilizing the multi-component implementation strategy for 7 months
Implementation Intervention: Virtual and in-person implementation support
|
Implementation as Usual
n=11000 Participants
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.
|
|---|---|---|
|
Implementation Effectiveness
|
42 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 6-months post-interventionPopulation: 48 patients with missing data; 19 staff missing data
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.
Outcome measures
| Measure |
Implementation Intervention
n=2 Emergency Departments
Through virtual and in-person meetings, the internal/external facilitation team will support sites in utilizing the multi-component implementation strategy for 7 months
Implementation Intervention: Virtual and in-person implementation support
|
Implementation as Usual
n=2 Emergency Departments
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.
|
|---|---|---|
|
Implementation Feasibility Using the Feasibility of Intervention Measure (FIM)
|
4.30 score on a Likert scale
Standard Deviation .95
|
3.89 score on a Likert scale
Standard Deviation .85
|
SECONDARY outcome
Timeframe: 6-months post-interventionPopulation: 48 patients missing data; 21 staff missing data
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.
Outcome measures
| Measure |
Implementation Intervention
n=50 Participants
Through virtual and in-person meetings, the internal/external facilitation team will support sites in utilizing the multi-component implementation strategy for 7 months
Implementation Intervention: Virtual and in-person implementation support
|
Implementation as Usual
n=98 Participants
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.
|
|---|---|---|
|
Implementation Acceptability Using the Acceptability of Intervention Measure (AIM)
|
4.35 score on a Likert scale
Standard Deviation .63
|
4.06 score on a Likert scale
Standard Deviation .71
|
Adverse Events
Implementation Intervention
Implementation as Usual
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place