NCT01602172

Brief Summary

Veterans drink, binge drink, and drive under the influence of alcohol at higher rates than non-Veterans do. Addressing alcohol misuse, the range of alcohol consumption from risky drinking to alcohol abuse and alcoholism, is a national priority for the VA. It is recommended that people keep their alcohol consumption below limits established by the National Institutes of Health (NIH). A type of 10-15 minute counseling known as "brief intervention" (BI) has been shown to help risky drinkers cut back to the NIH-recommended limits. This study will examine the impact of a nurse-delivered alcohol BI on hospitalized Veterans' weekly number of drinks, monthly number of binge drinking episodes, readiness to change drinking behavior, and alcohol-related problems. This preventative approach for reducing alcohol consumption is intended to help Veterans avoid many of the physical and psychosocial consequences of alcohol misuse.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

May 16, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 18, 2012

Completed
7 months until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

September 9, 2019

Completed
Last Updated

September 17, 2019

Status Verified

September 1, 2019

Enrollment Period

2.1 years

First QC Date

May 16, 2012

Results QC Date

June 23, 2017

Last Update Submit

September 6, 2019

Conditions

Alcohol Consumption

Keywords

alcohol consumptioninpatientsrisk reduction behaviorcounselingnursesbrief intervention

Outcome Measures

Primary Outcomes (1)

  • Number of Standard Drinks Per Week

    Number of Drinks per Week was determined by the product of responses to the following two NIAAA questions during the recruitment and screening processes : (1) On average, how many days a week do you have an alcoholic drink?; (2) On a typical drinking day, how many standard-sized drinks do you have? (Appendix 2). "Standard-sized drink" will refer to 12 ounces beer, 5 ounces wine, or 1.5 ounces liquor/spirits.

    6 months

Secondary Outcomes (4)

  • Alcohol Screening Status

    6 months

  • Number of Binge Drinking Episodes Over Past 30 Days

    6 months

  • Readiness to Change Drinking Behavior

    6 months

  • Adverse Consequences of Alcohol Use

    6 months

Other Outcomes (1)

  • Number of Participants Who Were Interested and Motivated to Change Their Alcohol Consumption

    Baseline

Study Arms (3)

Brief Alcohol Intervention (BI)

EXPERIMENTAL

The 3-part Brief Intervention (BI) consists of . Part I is 15-minute multi-component motivational discussion in hospital which includes personalized risk feedback, advice to abstain or reduce consumption, and the negotiation of an individual change plan. Part II is 15-minute follow-up in hospital to reinforce Part I. Part III is 15-minute follow-up telephone call at 2 weeks to reinforce Part I.

Behavioral: Brief Alcohol Intervention

Attention Control

ACTIVE COMPARATOR

These subjects receive a set of Lifestyle brochures which contain information and tips for healthy lifestyle behaviors such as alcohol and tobacco use, weight management, and physical activity. Two weeks later, the Research Assistant calls subjects in this condition at home for a 5-15 minute session to review the brochures and discuss any questions that s(he) may have. This intervention is designed to provide all the information and assessments that that Brief Intervention participants as well as all the alcohol consumption and motivation to change measures-- it is designed to control for the attention that the BI participants receive w/o the motivational interventions

Other: Lifestyle brochures

Control

ACTIVE COMPARATOR

These subjects receive a set of Lifestyle brochures which contain information and tips for healthy lifestyle behaviors such as alcohol and tobacco use, weight management, and physical activity to discuss with the Research Assistant. Approximately two weeks later, the Research Assistant will call patients in this condition at home for a 5-15 minute session to review the brochures and discuss any questions that s(he) may have. Subjects complete only drinking quantity measures at baseline and 6 months post baseline. The inclusion of this group tests whether completing more extensive questionnaires (in comparison the Attention Control group) decreases alcohol consumption.

Other: Lifestyle brochures

Interventions

Brief Alcohol InterventionBEHAVIORAL

3 part intervention: Part I is 15-minute multi-component motivational discussion in hospital which includes personalized risk feedback, advice to abstain or reduce consumption, and the negotiation of an individual change plan. Part II is 15-minute follow-up in hospital to reinforce Part I. Part III is 15-minute follow-up telephone call at 2 weeks to reinforce Part I.

Brief Alcohol Intervention (BI)
Lifestyle brochuresOTHER

Set of educational brochures/brochures which contain information and tips for healthy lifestyle behaviors such as alcohol and tobacco use, weight management, and physical activity to discuss with the Research Assistant. Approximately two weeks later, the Research Assistant will call patients in this condition at home for a 5-15 minute session to review the brochures and discuss any questions that s(he) may have.

Attention ControlControl

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • U.S. Veterans admitted to one of the three medical-surgical units at VA Pittsburgh Healthcare System (VAPHS)
  • age 21 years or older
  • ability to speak English
  • hazardous, non-dependent alcohol consumption

You may not qualify if:

  • Alcohol dependence (as determined using Section C (Alcohol) from the Composite International Diagnostic Interview Substance Abuse Module (CIDI-SAM)
  • Current participation (past 6 months) in substance abuse treatment or 12-step program
  • age \<21 years
  • significant cognitive impairment (as determined by the Short Blessed test , score \>10)
  • bipolar disorder or active psychosis
  • sensory impairment precluding communication
  • medically-related inability to participate or consent to study participation
  • current pregnancy
  • current incarceration
  • lack of telephone access or unwillingness to be contacted for follow-up
  • enrollment in the study during a prior inpatient admission at VAPHS
  • current enrollment in other substance use trials (due to the potential influence of dual participation on study outcomes)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

Related Publications (2)

  • Broyles LM, Wieland ME, Confer AL, Youk AO, Gordon AJ. Holes in the pipeline: addressing recruitment challenges for an alcohol brief intervention trial in the acute care setting. [Abstract]. Substance Abuse. 2014 Jan 1; 35(2):208.

    RESULT

  • Broyles LM, Wieland ME, Confer AL, DiNardo MM, Kraemer KL, Hanusa BH, Youk AO, Gordon AJ, Sevick MA. Alcohol brief intervention for hospitalized veterans with hazardous drinking: protocol for a 3-arm randomized controlled efficacy trial. Addict Sci Clin Pract. 2015 May 13;10(1):13. doi: 10.1186/s13722-015-0033-6.

    PMID: 25968121RESULT

Related Links

MeSH Terms

Conditions

Alcohol DrinkingRisk Reduction Behavior

Interventions

EthanolMethods

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsInvestigative Techniques

Results Point of Contact

Title
Lauren M. Broyles, PhD, RN
Organization
VA Pittsburgh Healthcare System
Lauren.Broyles@va.gov
412-360-2269

Study Officials

  • Lauren M. Broyles, PhD RN

    VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2012

First Posted

May 18, 2012

Study Start

December 1, 2012

Primary Completion

January 1, 2015

Study Completion

December 1, 2015

Last Updated

September 17, 2019

Results First Posted

September 9, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)