NCT01326169

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
730

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 30, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

September 11, 2014

Status Verified

September 1, 2014

Enrollment Period

3 years

First QC Date

March 28, 2011

Last Update Submit

September 10, 2014

Conditions

Alcohol Drinking

Keywords

Alcoholbrief interventioninjuries

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Evaluation of mechanisms of change model

    12 months post-randomization

Study Arms (2)

Standard care

ACTIVE COMPARATOR

No intervention

Behavioral: Standard care

Counseling

EXPERIMENTAL

Telephone-delivered counseling

Behavioral: Brief intervention

Interventions

Brief interventionBEHAVIORAL

Telephone-delivered counseling

Counseling
Standard careBEHAVIORAL

No intervention

Standard care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English or Spanish speaking
  • Age greater than 17 years
  • ASSIST score \>=11
  • Injured Emergency Department patient at time of consent

You may not qualify if:

  • Medically unable to give consent
  • Not English or Spanish speaking
  • Homeless
  • Cannot be contacted by telephone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Related Publications (1)

  • 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.

    PMID: 26585044DERIVED

MeSH Terms

Conditions

Alcohol DrinkingWounds and Injuries

Interventions

Crisis InterventionStandard of Care

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and ActivitiesQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Michael J Mello, MD, MPH

    Rhode Island Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 28, 2011

First Posted

March 30, 2011

Study Start

March 1, 2010

Primary Completion

March 1, 2013

Study Completion

May 1, 2014

Last Updated

September 11, 2014

Record last verified: 2014-09

Locations

US(2)