Overview

This trial is active, not recruiting.

Condition alcohol consumption
Treatments brief alcohol intervention, lifestyle brochures
Sponsor Department of Veterans Affairs
Start date November 2012
End date January 2015
Trial size 426 participants
Trial identifier NCT01602172, NRI 11-339

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose health services research
Arm
(Experimental)
Brief Intervention Condition--3 part motivational discussion in and out of hospital
brief alcohol intervention
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.
(Active Comparator)
Traditional Attention Control Condition
lifestyle brochures
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.
(Active Comparator)
Attention Control, Limited Assessment
lifestyle brochures
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.

Primary Outcomes

Measure
Number of standard drinks per week
time frame: 6 months

Secondary Outcomes

Measure
Alcohol screening status
time frame: 6 months
Number of binge drinking episodes over past 30 days
time frame: 6 months
Readiness to change drinking behavior
time frame: 6 months
Adverse consequences of alcohol use
time frame: 6 months

Eligibility Criteria

Male or female participants at least 21 years old.

Inclusion Criteria: - 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 Exclusion Criteria: - 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)

Additional Information

Official title Trial of Nurse-delivered Alcohol Brief Intervention for Hospitalized Veterans
Principal investigator Lauren M. Broyles, PhD RN
Description Improving the identification and management of alcohol misuse is a VA priority. Alcohol misuse includes the spectrum of alcohol consumption ranging from hazardous drinking to alcohol use disorders (alcohol abuse and dependence). The VA recommends using a set of clinical strategies referred to as Screening, Brief Intervention, and Referral to Treatment (SBIRT) to identify and address alcohol misuse in primary care settings. Brief intervention (BI), a core component of SBIRT, significantly reduces alcohol consumption, morbidity, and healthcare utilization in hazardous drinkers, but its efficacy is not well-established outside of outpatient settings. In the hospital setting, nurses are well-positioned to deliver BI, but research is needed to determine the efficacy of inpatient nurse-delivered BI, particularly with hazardous drinkers. The few previous trials of BI in the inpatient setting demonstrated limited effects on alcohol consumption and alcohol-related problems, potentially due to assessment reactivity--extensive patient assessment that inadvertently raises patient awareness about drinking in both groups, mimicking the effect of BI and thus driving findings towards the null. Additionally, very few of these trials involved nurse delivery of the intervention and many included patients with alcohol use disorders, patients believed to be beyond the "therapeutic reach" of BI. The primary goal of this 3-arm randomized controlled trial is to examine the efficacy of nurse-delivered alcohol BI with hospitalized patients who are hazardous drinkers and to identify barriers and facilitators to implementation of BI in inpatient settings. Arm 1 (BI) consists of Veterans randomized to nurse-delivered BI, Arm 2 (AC) consists of Veterans randomized to an attention control, and Arm 3 (AC-LA) consists of Veterans randomized to an attention control with limited assessment of readiness to change and adverse consequences of alcohol use so as to reduce and evaluate assessment reactivity. Specific Aim 1 is to determine the impact of a nurse-led BI on the alcohol screening status, number of drinks/week, number of binge drinking episodes, readiness to change drinking behavior, and adverse consequences of alcohol use in hospitalized hazardous drinkers. Specific Aim 2 is to formatively evaluate the process of the intervention implementation to inform the design and execution of a future, multi-site randomized effectiveness trial of the intervention. A secondary aim is to identify factors, issues, and themes related to Veterans' interest and motivation for changing their alcohol consumption. We will recruit 320 hospitalized Veterans admitted to one of the three medical-surgical units at the VA Pittsburgh Healthcare System. Veterans will be included who are >21 years old, able to speak English, and are hazardous, non-dependent drinkers, as defined by criteria established by the National Institute for Alcohol Abuse and Alcoholism and by the Composite International Diagnostic Interview Substance Abuse Module. Patients randomized to Arm 1 will receive a three-part nurse-delivered BI. Patients randomized to Arms 2 and 3 will receive usual care plus healthy lifestyle brochures addressing general healthy lifestyle behaviors, such as limited alcohol consumption, tobacco cessation, and weight management. For Specific Aim 1, we will use various multivariable linear and logistic regressions that account for continuous outcomes, dichotomous outcomes, and clustering within medical units. Poisson regressions or negative binomial regressions will be used if the continuous outcome measures are not normally distributed. For Specific Aim 2, we will use basic descriptive statistics in order to describe the numbers of deviations and interruptions to intervention delivery as planned. Based on interventionist field notes, we will categorize the types of deviations/interruptions. We will also use these descriptive statistics to describe duration of the audio-recorded intervention; the presence/absence of various techniques within the BI; the receipt/nonreceipt of additional alcohol feedback, advice, or counseling; and patient responsiveness to/perceptions of the BI. We will also code brief free-text perceptions responses using a modified grounded theory approach.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Department of Veterans Affairs.