Alcohol Consumption
Conditions
Keywords
alcohol consumption, inpatients, risk reduction behavior, counseling, nurses, brief intervention
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.
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.
Interventions
BEHAVIORALBrief 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.
OTHERLifestyle 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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Standard Drinks Per Week | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol Screening Status | 6 months | 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. AUDIT-C scores range from 0-12, with higher values representing a worse outcome (a score of 4 indicating hazardous drinking in males and 3 hazardous drinking in females).Generally, the higher the AUDIT-C score, the more likely it is that the patient's drinking is affecting his/her health and safety. |
| Number of Binge Drinking Episodes Over Past 30 Days | 6 months | 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 | 6 months | 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. SOCRATES is a 19-item instrument with 3 subscales where minimum score is 19 and the maximum score is 95. Lower totals representing lesser readiness/eagerness for change and higher totals representing greater readiness/eagerness to change. With the three sub scales (Recognition, Ambivalence, and Taking Steps), higher scores indicate greater recognition, ambivalence and taking steps and scores range from 7 to 35, 4 to 20, and 8 to 40, respectively. |
| Adverse Consequences of Alcohol Use | 6 months | 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 BI and Attention Control) 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. The SIP-2R was used as a continuous measure with possible scores from 0-45, where each item has a score from 0-3 (0=Never, 1=once or a few times, 2=once or twice a week, 3=daily or almost daily). Higher scores indicate a worse outcome. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Were Interested and Motivated to Change Their Alcohol Consumption | Baseline | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred December 2012 to June 2014 on three medical-surgical units at the VA Pittsburgh Healthcare System.
Pre-assignment details
Not applicable; no enrolled participants were excluded from the trial prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| Brief Alcohol Intervention (BI) 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. | 37 |
| Attention Control 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. | 23 |
| Control 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. | 22 |
| Total | 82 |
Baseline characteristics
| Characteristic | Total | Brief Alcohol Intervention (BI) | Attention Control | Control |
|---|---|---|---|---|
| Age, Continuous | 59.18 years STANDARD_DEVIATION 11.67 | 57.3 years STANDARD_DEVIATION 13.16 | 62.70 years STANDARD_DEVIATION 9.1 | 58.68 years STANDARD_DEVIATION 11.02 |
| Alcohol Use Disorders Identification Test-Consumption | 6.54 units on a scale STANDARD_DEVIATION 2.33 | 6.11 units on a scale STANDARD_DEVIATION 2.47 | 7.43 units on a scale STANDARD_DEVIATION 2.25 | 6.36 units on a scale STANDARD_DEVIATION 1.97 |
| Number of Binge Episodes/Week | 5.48 count of binge episodes per week STANDARD_DEVIATION 8.48 | 4.22 count of binge episodes per week STANDARD_DEVIATION 7.31 | 7.61 count of binge episodes per week STANDARD_DEVIATION 9.9 | 5.36 count of binge episodes per week STANDARD_DEVIATION 8.68 |
| Race/Ethnicity, Customized Race Black | 13 Participants | 6 Participants | 4 Participants | 3 Participants |
| Race/Ethnicity, Customized Race White | 69 Participants | 31 Participants | 19 Participants | 19 Participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 80 Participants | 35 Participants | 23 Participants | 22 Participants |
| SIP-2R Score | 4.72 units on a scale STANDARD_DEVIATION 6.96 | 4.43 units on a scale STANDARD_DEVIATION 5.19 | 5.17 units on a scale STANDARD_DEVIATION 9.24 | — |
| Socrates Score | 19.82 units on a scale STANDARD_DEVIATION 4.72 | 21.86 units on a scale STANDARD_DEVIATION 8.43 | 16.52 units on a scale STANDARD_DEVIATION 10.48 | — |
| Weekly number of drinks | 18.52 count of drinks per week STANDARD_DEVIATION 14.77 | 17.36 count of drinks per week STANDARD_DEVIATION 16.53 | 20.78 count of drinks per week STANDARD_DEVIATION 14.76 | 18.04 count of drinks per week STANDARD_DEVIATION 11.81 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 37 | 3 / 23 | 0 / 22 |
| other Total, other adverse events | 5 / 37 | 0 / 23 | 0 / 22 |
| serious Total, serious adverse events | 0 / 37 | 0 / 23 | 0 / 22 |
Outcome results
Primary
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.
Time frame: 6 months
Population: Reflects number of participant that completed the 6 month interview
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brief Intervention | Number of Standard Drinks Per Week | 11.19 days/week drink * amt of drinks in day | Standard Deviation 14.39 |
| Attention Control | Number of Standard Drinks Per Week | 13.12 days/week drink * amt of drinks in day | Standard Deviation 10.93 |
| Control | Number of Standard Drinks Per Week | 14.00 days/week drink * amt of drinks in day | Standard Deviation 4.05 |
Secondary
Adverse Consequences of Alcohol Use
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 BI and Attention Control) 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. The SIP-2R was used as a continuous measure with possible scores from 0-45, where each item has a score from 0-3 (0=Never, 1=once or a few times, 2=once or twice a week, 3=daily or almost daily). Higher scores indicate a worse outcome.
Time frame: 6 months
Population: Participants the completed the 6 month interview
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brief Intervention | Adverse Consequences of Alcohol Use | 5.09 units on a scale | Standard Deviation 3.03 |
| Attention Control | Adverse Consequences of Alcohol Use | 5.41 units on a scale | Standard Deviation 2.98 |
| Control | Adverse Consequences of Alcohol Use | 5.27 units on a scale | Standard Deviation 2.35 |
Secondary
Alcohol Screening Status
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. AUDIT-C scores range from 0-12, with higher values representing a worse outcome (a score of 4 indicating hazardous drinking in males and 3 hazardous drinking in females).Generally, the higher the AUDIT-C score, the more likely it is that the patient's drinking is affecting his/her health and safety.
Time frame: 6 months
Population: Only participants that completed the 6 month interview
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brief Intervention | Alcohol Screening Status | 5.09 units on a scale | Standard Deviation 3.03 |
| Attention Control | Alcohol Screening Status | 5.41 units on a scale | Standard Deviation 2.98 |
| Control | Alcohol Screening Status | 5.27 units on a scale | Standard Deviation 2.35 |
Comparison: Measures were compared with linear mixed effects regression models to compare impact of BI compared to usual care conditions. Analyses reported here included only those that completed the 6 month interview (71/82 baseline participants).p-value: 0.05Mixed Models Analysis
Secondary
Number of Binge Drinking Episodes Over Past 30 Days
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)
Time frame: 6 months
Population: Participants the completed the 6 month interviews
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brief Intervention | Number of Binge Drinking Episodes Over Past 30 Days | 2.25 binge drinking episodes | Standard Deviation 4.72 |
| Attention Control | Number of Binge Drinking Episodes Over Past 30 Days | 4.65 binge drinking episodes | Standard Deviation 7.72 |
| Control | Number of Binge Drinking Episodes Over Past 30 Days | 4.14 binge drinking episodes | Standard Deviation 8.29 |
Secondary
Readiness to Change Drinking Behavior
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. SOCRATES is a 19-item instrument with 3 subscales where minimum score is 19 and the maximum score is 95. Lower totals representing lesser readiness/eagerness for change and higher totals representing greater readiness/eagerness to change. With the three sub scales (Recognition, Ambivalence, and Taking Steps), higher scores indicate greater recognition, ambivalence and taking steps and scores range from 7 to 35, 4 to 20, and 8 to 40, respectively.
Time frame: 6 months
Population: Individuals that completed the 6 month interview
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brief Intervention | Readiness to Change Drinking Behavior | 23.16 units on a scale | Standard Deviation 9.09 |
| Attention Control | Readiness to Change Drinking Behavior | 17.88 units on a scale | Standard Deviation 8.48 |
| Control | Readiness to Change Drinking Behavior | 17.00 units on a scale | Standard Deviation 6.52 |
Other Pre-specified
Number of Participants Who Were Interested and Motivated to Change Their Alcohol Consumption
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.
Time frame: Baseline
Population: Data were not collected from the Attention Control and Control Groups
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brief Intervention | Number of Participants Who Were Interested and Motivated to Change Their Alcohol Consumption | 37 Participants |