NCT02228967

Brief Summary

An alcohol Screening, Brief Intervention and Referral to Treatment (SBIRT) approach will be adapted for use in a large military hospital setting, and then pilot tested in a military emergency department (ED) to assess its potential for effectiveness and for further testing in a large-scale trial. SBIRT is an "opportunistic" approach whereby all adult patients in the ED are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk. The feasibility/formative research activities in the first phase (Phase I) of the study are not summative research, and therefore, do not lend themselves to testable hypotheses. Hypotheses with regard to the pilot randomized trial in Phase II are as follows:

  1. 1.Participants in the SBIRT intervention will show relatively greater reductions over a six month period (or less increase) than the brochure/usual care control group in the prevalence of past-month heavy drinking, frequency of heavy drinking, past week number of drinks, and the AUDIT-based drinkers' index.
  2. 2.Alcohol use-related motivation/readiness to change and controlled drinking self-efficacy will show greater change in the SBIRT intervention group relative to the brochure/usual care control group.
  3. 3.Sociodemographic/military variables (e.g., age, race/ethnicity, gender, branch of service, officer/enlisted status, PTS) and social-psychological factors (e.g., baseline readiness to change, self efficacy) will mediate or moderate changes in alcohol misuse.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
791

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

August 26, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2014

Completed
11 months until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
12 months until next milestone

Results Posted

Study results publicly available

July 25, 2019

Completed
Last Updated

September 9, 2020

Status Verified

August 1, 2020

Enrollment Period

1.2 years

First QC Date

August 26, 2014

Results QC Date

November 7, 2018

Last Update Submit

August 21, 2020

Conditions

Keywords

Alcohol UseSBIRTMilitaryHealth BehaviorEmergency RoomHealth PromotionFormative ResearchRandomized Trial

Outcome Measures

Primary Outcomes (1)

  • Alcohol Use Disorders Identification Test (AUDIT) Total

    The primary outcome measure will come from the participant's total score on the AUDIT. Scores on the AUDIT range from 0 to 40 with higher numbers indicating greater problematic alcohol use. Mean AUDIT scores at follow-up will be compared between arms.

    Baseline, Follow-up (Up to 7 months)

Secondary Outcomes (3)

  • AUDIT-C or Drinkers Index

    Baseline, Follow-up (Up to 7 months)

  • Controlled Drinking Self-Efficacy Scale (CDSES)

    Baseline, Follow-up (Up to 7 months)

  • Readiness to Change Scale

    Baseline, Follow-up (Up to 7 months)

Study Arms (2)

Usual Care

NO INTERVENTION

Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.

SBIRT

ACTIVE COMPARATOR

Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: 1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. 2. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. 3. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support.

Behavioral: SBIRT

Interventions

SBIRTBEHAVIORAL

SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.

Also known as: Screening, Brief Intervention, Brief Treatment, Referral to Treatment, Motivational Interviewing
SBIRT

Eligibility Criteria

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

You may qualify if:

  • or Older
  • Active Duty
  • Off Duty
  • Telephone Number for Follow-up
  • Healthy Enough to Participate
  • Positive Screen for Risky Drinking

You may not qualify if:

  • Under 18
  • Non-Military
  • On Duty
  • Low Level Drinking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location

MeSH Terms

Conditions

AlcoholismAlcohol DrinkingHealth BehaviorEmergencies

Interventions

Mass ScreeningCrisis InterventionMotivational Interviewing

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersDrinking BehaviorBehaviorDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health PracticePsychotherapyBehavioral Disciplines and ActivitiesDirective CounselingCounselingMental Health Services

Results Point of Contact

Title
Mark B. Reed/Professor and Interim Associate Dean
Organization
San Diego State University Research Foundation

Study Officials

  • Mark Reed, PhD

    SDSURF - Center for Alcohol & Drug Studies & Services

    PRINCIPAL INVESTIGATOR
  • Gerard DeMers, DO

    United States Naval Medical Center, San Diego

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

August 26, 2014

First Posted

August 29, 2014

Study Start

August 1, 2015

Primary Completion

October 1, 2016

Study Completion

August 1, 2018

Last Updated

September 9, 2020

Results First Posted

July 25, 2019

Record last verified: 2020-08

Locations