Health Behavior Change for Hospitalized Veterans

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01602172
First received: May 16, 2012
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Alcohol Consumption
Behavioral: Brief Alcohol Intervention
Other: Lifestyle brochures

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Trial of Nurse-delivered Alcohol Brief Intervention for Hospitalized Veterans

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Number of standard drinks per week [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Number of Drinks per Week will be 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.


Secondary Outcome Measures:
  • Alcohol screening status [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Alcohol Screening Status will be assessed using the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) (Appendix 2), the 3-item short form of the 10-item Alcohol Use Disorders Identification Test (AUDIT) developed by the World Health Organization. AUDIT-C data will be collected during the recruitment and screening processes.

  • Number of binge drinking episodes over past 30 days [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Number of Binge Drinking Episodes will be assessed through a third NIAAA question during the recruitment and screening processes: (3) How many times in the past 30 days have you had 5 or more standard-sized drinks in a day (men), or 4 or more standard-sized drinks in a day? (women)

  • Readiness to change drinking behavior [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    We will assess readiness to change with the Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES), Version 8.This instrument was created by one of the initial developers of Motivational Interviewing, the therapeutic style on which SBIRT is based. The SOCRATES is a 19-item instrument with 3 subscales: Recognition (of a potential alcohol problem), Ambivalence (about one's drinking), and Taking Steps (towards behavior change), and normative data are available to aid in subscale score interpretation.

  • Adverse consequences of alcohol use [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    We will assess adverse consequences of alcohol use with the Short Inventory of Problems (SIP-2R), a widely used 15-item stand-alone short version of the Drinker Inventory of Consequences (DrInC).The SIP-2R will be administered at baseline (for Arms 1 and 2) and at 6 months post-hospital discharge (all groups) to assesses adverse consequences of alcohol use over the past three months in five areas: Interpersonal, Physical, Social, Impulsive, and Intrapersonal.


Other Outcome Measures:
  • Factors, issues, and themes related to Veteran's interest and motivation for changing their alcohol consumption [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Among Veterans randomized to Arm 1, we will analyze the transcripts of Part I of the audio-recorded brief intervention. Descriptive statistics (e.g., frequency distributions, measures of central tendency) will be used to characterize the anonymous sociodemographic, educational, and patient care characteristics of the participants. Transcript data will be analyzed using the grounded theory technique of constant comparison. Similar or related codes will be collapsed into focused codes in order to represent interrelationships, variations, and underlying patterns in the data, allowing for the identification of factors, issues, and themes related to Veterans interest and motivation for changing their alcohol consumption.


Estimated Enrollment: 426
Study Start Date: November 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Brief Intervention Condition--3 part motivational discussion in and out of hospital
Behavioral: 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: Arm 2
Traditional Attention Control Condition
Other: 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: Arm 3
Attention Control, Limited Assessment
Other: 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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  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: NCT01602172

Contacts
Contact: Lauren M Broyles, PhD RN (412) 954-5269 Lauren.Broyles@va.gov
Contact: Adam J Gordon, MD MPH (412) 954-5214 adam.gordon@va.gov

Locations
United States, Pennsylvania
Center for Health Equity Research and Promotion Recruiting
Pittsburgh, Pennsylvania, United States, 15206
Contact: Lauren M Broyles, PhD RN    (412) 954-5269    Lauren.Broyles@va.gov   
Contact: Adam J Gordon, MD MPH    (412) 954-5214    adam.gordon@va.gov   
Sub-Investigator: Adam J. Gordon, MD MPH         
Sub-Investigator: Keri L. Rodriguez, PhD         
Principal Investigator: Lauren M. Broyles, PhD RN         
Sub-Investigator: Mary Ann Sevick, ScD MS         
Sub-Investigator: Michael J. Fine, MD MSc         
Sponsors and Collaborators
Investigators
Principal Investigator: Lauren M. Broyles, PhD RN Center for Health Equity Research and Promotion
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01602172     History of Changes
Other Study ID Numbers: NRI 11-339
Study First Received: May 16, 2012
Last Updated: June 4, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
alcohol consumption
inpatients
risk reduction behavior
counseling
nurses
brief intervention

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 19, 2014