ReDIAL: A Telephone Brief Intervention for Injured Emergency Department Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Rhode Island Hospital.
Recruitment status was  Recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014