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ReDIAL: A Telephone Brief Intervention for Injured Emergency Department Patients

This study is currently recruiting participants.
Verified October 2011 by Rhode Island Hospital
Sponsor:
Information provided by (Responsible Party):
Michael J. Mello, MD, MPH, Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT01326169
First received: March 28, 2011
Last updated: October 18, 2011
Last verified: October 2011
History of Changes
  Purpose

The goal of this study is to reduce impaired driving, risky driving and alcohol-related negative consequences among injured 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.


Condition Intervention Phase
Alcohol Drinking
 Behavioral: Brief intervention
Behavioral: Standard care
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ReDIAL: A Telephone Brief Intervention for Injured Emergency Department Patients

Resource links provided by NLM:

MedlinePlus related topics: Alcohol
U.S. FDA Resources

Further study details as provided by Rhode Island Hospital:

Primary Outcome Measures:
  • Change in number of patients with alcohol-related negative consequences from baseline to 4, 8, and 12 months post-randomization [ Time Frame: Change from baseline in alcohol-related negatve consequences at 4, 8, and 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months post-randomization ] [ Designated as safety issue: No ]
    Determine the moderators and mediators of primary outcomes.


Estimated Enrollment: 516
Study Start Date: March 2010
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard care
No intervention
 Behavioral: Standard care
No intervention
Experimental: Counseling
Telephone-delivered counseling
 Behavioral: Brief intervention
Telephone-delivered counseling

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01326169

Contacts
Contact: Valerie M Strezsak, MS 401-444-4608 vstrezsak@lifespan.org
Contact: Michael J Mello, MD, MPH 401-444-6684 mjmello@lifespan.org

Locations
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Valerie M Strezsak, MS     401-444-4608     vstrezsak@lifespan.org    
Principal Investigator: Michael J Mello, MD, MPH            
The Miriam Hospital Recruiting
Providence, Rhode Island, United States, 02906
Contact: Valerie M Strezsak, MS     401-444-4608     vstrezsak@lifespan.org    
Principal Investigator: Michael J Mello, MD, MPH            
Sponsors and Collaborators
Rhode Island Hospital
Investigators
Principal Investigator: Michael J Mello, MD, MPH Rhode Island Hospital
  More Information

No publications provided

Responsible Party: Michael J. Mello, MD, MPH, Principal Investigator, Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT01326169     History of Changes
Other Study ID Numbers: 1 R01 AA017895
Study First Received: March 28, 2011
Last Updated: October 18, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Rhode Island Hospital:
Alcohol
brief intervention
injuries

Additional relevant MeSH terms:
Alcohol Drinking
Emergencies
Drinking Behavior
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013