ReDIAL: A Telephone Brief Intervention for Injured Emergency Department Patients

Alcohol Drinking Clinical Trial

— ReDIAL  

Official title:

ReDIAL: A Telephone Brief Intervention for Injured Emergency Department Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01326169
• Other study ID #: 1R01AA017895
• Status: Completed
• Phase: N/A
• First received: March 28, 2011
• Last updated: September 10, 2014
• Start date: March 2010
• Est. completion date: May 2014

Study information

• Verified date: September 2014
• Source: Rhode Island Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to reduce impaired driving, risky driving and alcohol-related negative consequences among injured emergency department (ED) patients through a telephone brief intervention. This study will allow researchers to test a novel method of brief intervention that has the potential to be convenient and efficient mechanism to deliver an intervention to an at-risk population. Eligible patients will be consented in the ED, will receive an assessment and then will be randomized into one of two conditions: 1) telephone brief intervention or 2) a comparison control group with a home safety educational program. The participant will also receive an appointment for an initial telephone call. Both conditions will be provided over three telephone sessions: the initial call (immediately following randomization) and two booster calls at 2 weeks and 6 weeks after randomization. Participants will provide information about their alcohol use, alcohol-related injuries, impaired driving, and other driving related negative consequences at 4, 8, and 12 months post-randomization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 730
• Est. completion date: May 2014
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• English or Spanish speaking

• Age greater than 17 years

• ASSIST score >=11

• Injured Emergency Department patient at time of consent

Exclusion Criteria:

• Medically unable to give consent

• Not English or Spanish speaking

• Homeless

• Cannot be contacted by telephone

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Drinking

Intervention

Behavioral:
• Brief intervention
Telephone-delivered counseling
• Standard care
No intervention

Locations

Country	Name	City	State
United States	Rhode Island Hospital	Providence	Rhode Island
United States	The Miriam Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Rhode Island Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in number of patients with alcohol-related negative consequences from baseline to 4, 8, and 12 months post-randomization	Specifically, the effect of the intervention on alcohol-related injuries and alcohol-related psychosocial consequences from baseline at 4, 8, and 12 months post-randomization.	Change from baseline in alcohol-related negatve consequences at 4, 8, and 12 months	No
Secondary	Evaluation of mechanisms of change model	Determine the moderators and mediators of primary outcomes.	12 months post-randomization	No