ReDIAL: A Telephone Brief Intervention for Injured Emergency Department Patients (ReDIAL)
Primary Purpose
Alcohol Drinking
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief intervention
Standard care
Sponsored by

About this trial
This is an interventional treatment trial for Alcohol Drinking focused on measuring Alcohol, brief intervention, injuries
Eligibility Criteria
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
Sites / Locations
- Rhode Island Hospital
- The Miriam Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard care
Counseling
Arm Description
No intervention
Telephone-delivered counseling
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Evaluation of mechanisms of change model
Determine the moderators and mediators of primary outcomes.
Full Information
NCT ID
NCT01326169
First Posted
March 28, 2011
Last Updated
September 10, 2014
Sponsor
Rhode Island Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01326169
Brief Title
ReDIAL: A Telephone Brief Intervention for Injured Emergency Department Patients
Acronym
ReDIAL
Official Title
ReDIAL: A Telephone Brief Intervention for Injured Emergency Department Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rhode Island Hospital
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking
Keywords
Alcohol, brief intervention, injuries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
730 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard care
Arm Type
Active Comparator
Arm Description
No intervention
Arm Title
Counseling
Arm Type
Experimental
Arm Description
Telephone-delivered counseling
Intervention Type
Behavioral
Intervention Name(s)
Brief intervention
Intervention Description
Telephone-delivered counseling
Intervention Type
Behavioral
Intervention Name(s)
Standard care
Intervention Description
No intervention
Primary Outcome Measure Information:
Title
Change in number of patients with alcohol-related negative consequences from baseline to 4, 8, and 12 months post-randomization
Description
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.
Time Frame
Change from baseline in alcohol-related negatve consequences at 4, 8, and 12 months
Secondary Outcome Measure Information:
Title
Evaluation of mechanisms of change model
Description
Determine the moderators and mediators of primary outcomes.
Time Frame
12 months post-randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Mello, MD, MPH
Organizational Affiliation
Rhode Island Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26585044
Citation
Mello MJ, Baird J, Lee C, Strezsak V, French MT, Longabaugh R. A Randomized Controlled Trial of a Telephone Intervention for Alcohol Misuse With Injured Emergency Department Patients. Ann Emerg Med. 2016 Feb;67(2):263-75. doi: 10.1016/j.annemergmed.2015.09.021. Epub 2015 Nov 14.
Results Reference
derived
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ReDIAL: A Telephone Brief Intervention for Injured Emergency Department Patients
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