Trial Outcomes & Findings for Health Behavior Change for Hospitalized Veterans (NCT NCT01602172)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

82 participants

Primary outcome timeframe

6 months

Results posted on

2019-09-17

Participant Flow

Recruitment occurred December 2012 to June 2014 on three medical-surgical units at the VA Pittsburgh Healthcare System.

Not applicable; no enrolled participants were excluded from the trial prior to randomization.

Participant milestones

Participant milestones
Measure	Brief Alcohol Intervention (BI) Brief Intervention Condition--3 part motivational discussion in and out of hospital Brief Alcohol Intervention: 3 part intervention: Part I was a 15-minute multi-component motivational discussion in hospital which included personalized risk feedback, advice to abstain or reduce consumption, and the negotiation of an individual change plan. Part II was a 15-minute follow-up in hospital to reinforce Part I. Part III was 15-minute follow-up telephone call at 2 weeks to reinforce Part I.	Attention Control Traditional Attention Control Condition Lifestyle brochures: Set of educational brochures/brochures which contained 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 called patients in this condition at home for a 5-15 minute session to review the brochures and discuss any questions that s(he) had.	Control Attention Control, Limited Assessment Lifestyle brochures: Set of educational brochures/brochures which contained 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 called patients in this condition at home for a 5-15 minute session to review the brochures and discuss any questions that s(he) had.
Overall Study STARTED	37	23	22
Overall Study COMPLETED	32	17	22
Overall Study NOT COMPLETED	5	6	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Only participants in the two active groups completed this scale

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Brief Alcohol Intervention (BI) n=37 Participants 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.	Attention Control n=23 Participants 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.	Control n=22 Participants 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.	Total n=82 Participants Total of all reporting groups
Age, Continuous	57.3 years STANDARD_DEVIATION 13.16 • n=37 Participants	62.70 years STANDARD_DEVIATION 9.10 • n=23 Participants	58.68 years STANDARD_DEVIATION 11.02 • n=22 Participants	59.18 years STANDARD_DEVIATION 11.67 • n=82 Participants
Sex: Female, Male Female	2 Participants n=37 Participants	0 Participants n=23 Participants	0 Participants n=22 Participants	2 Participants n=82 Participants
Sex: Female, Male Male	35 Participants n=37 Participants	23 Participants n=23 Participants	22 Participants n=22 Participants	80 Participants n=82 Participants
Race/Ethnicity, Customized Race · White	31 Participants n=37 Participants	19 Participants n=23 Participants	19 Participants n=22 Participants	69 Participants n=82 Participants
Race/Ethnicity, Customized Race · Black	6 Participants n=37 Participants	4 Participants n=23 Participants	3 Participants n=22 Participants	13 Participants n=82 Participants
Alcohol Use Disorders Identification Test-Consumption	6.11 units on a scale STANDARD_DEVIATION 2.47 • n=37 Participants	7.43 units on a scale STANDARD_DEVIATION 2.25 • n=23 Participants	6.36 units on a scale STANDARD_DEVIATION 1.97 • n=22 Participants	6.54 units on a scale STANDARD_DEVIATION 2.33 • n=82 Participants
Weekly number of drinks	17.36 count of drinks per week STANDARD_DEVIATION 16.53 • n=37 Participants	20.78 count of drinks per week STANDARD_DEVIATION 14.76 • n=23 Participants	18.04 count of drinks per week STANDARD_DEVIATION 11.81 • n=22 Participants	18.52 count of drinks per week STANDARD_DEVIATION 14.77 • n=82 Participants
Number of Binge Episodes/Week	4.22 count of binge episodes per week STANDARD_DEVIATION 7.31 • n=37 Participants	7.61 count of binge episodes per week STANDARD_DEVIATION 9.90 • n=23 Participants	5.36 count of binge episodes per week STANDARD_DEVIATION 8.68 • n=22 Participants	5.48 count of binge episodes per week STANDARD_DEVIATION 8.48 • n=82 Participants
Socrates Score	21.86 units on a scale STANDARD_DEVIATION 8.43 • n=37 Participants • Only participants in the two active groups completed this scale	16.52 units on a scale STANDARD_DEVIATION 10.48 • n=23 Participants • Only participants in the two active groups completed this scale	—	19.82 units on a scale STANDARD_DEVIATION 4.72 • n=60 Participants • Only participants in the two active groups completed this scale
SIP-2R Score	4.43 units on a scale STANDARD_DEVIATION 5.19 • n=37 Participants • Only participants in the two active groups completed this scale	5.17 units on a scale STANDARD_DEVIATION 9.24 • n=23 Participants • Only participants in the two active groups completed this scale	—	4.72 units on a scale STANDARD_DEVIATION 6.96 • n=60 Participants • Only participants in the two active groups completed this scale

PRIMARY outcome

Timeframe: 6 months

Population: Reflects number of participant that completed the 6 month interview

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.

Outcome measures

Outcome measures
Measure	Brief Intervention n=32 Participants 3-part Brief Intervention 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.	Attention Control n=17 Participants 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.	Control n=22 Participants 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.
Number of Standard Drinks Per Week	11.19 days/week drink * amt of drinks in day Standard Deviation 14.39	13.12 days/week drink * amt of drinks in day Standard Deviation 10.93	14.00 days/week drink * amt of drinks in day Standard Deviation 4.05

SECONDARY outcome

Timeframe: 6 months

Population: Only participants that completed the 6 month interview

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.

Outcome measures

Outcome measures
Measure	Brief Intervention n=32 Participants 3-part Brief Intervention 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.	Attention Control n=17 Participants 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.	Control n=22 Participants 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.
Alcohol Screening Status	5.09 units on a scale Standard Deviation 3.03	5.41 units on a scale Standard Deviation 2.98	5.27 units on a scale Standard Deviation 2.35

SECONDARY outcome

Timeframe: 6 months

Population: Participants the completed the 6 month interviews

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)

Outcome measures

Outcome measures
Measure	Brief Intervention n=32 Participants 3-part Brief Intervention 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.	Attention Control n=17 Participants 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.	Control n=22 Participants 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.
Number of Binge Drinking Episodes Over Past 30 Days	2.25 binge drinking episodes Standard Deviation 4.72	4.65 binge drinking episodes Standard Deviation 7.72	4.14 binge drinking episodes Standard Deviation 8.29

SECONDARY outcome

Timeframe: 6 months

Population: Individuals that completed the 6 month interview

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.

Outcome measures

Outcome measures
Measure	Brief Intervention n=32 Participants 3-part Brief Intervention 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.	Attention Control n=17 Participants 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.	Control n=22 Participants 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.
Readiness to Change Drinking Behavior	23.16 units on a scale Standard Deviation 9.09	17.88 units on a scale Standard Deviation 8.48	17.00 units on a scale Standard Deviation 6.52

SECONDARY outcome

Timeframe: 6 months

Population: Participants the completed the 6 month interview

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.

Outcome measures

Outcome measures
Measure	Brief Intervention n=32 Participants 3-part Brief Intervention 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.	Attention Control n=17 Participants 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.	Control n=22 Participants 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.
Adverse Consequences of Alcohol Use	5.09 units on a scale Standard Deviation 3.03	5.41 units on a scale Standard Deviation 2.98	5.27 units on a scale Standard Deviation 2.35

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: Data were not collected from the Attention Control and Control Groups

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.

Outcome measures

Outcome measures
Measure	Brief Intervention n=37 Participants 3-part Brief Intervention 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.	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.	Control 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.
Number of Participants Who Were Interested and Motivated to Change Their Alcohol Consumption	37 Participants	—	—

Adverse Events

Brief Alcohol Intervention (BI)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 1 deaths

Attention Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Brief Alcohol Intervention (BI) n=37 participants at risk Brief Intervention Condition--3 part motivational discussion in and out of hospital Brief Alcohol Intervention: 3 part intervention: Part I was a 15-minute multi-component motivational discussion in hospital which included personalized risk feedback, advice to abstain or reduce consumption, and the negotiation of an individual change plan. Part II was a 15-minute follow-up in hospital to reinforce Part I. Part III was 15-minute follow-up telephone call at 2 weeks to reinforce Part I.	Attention Control n=23 participants at risk Traditional Attention Control Condition Lifestyle brochures: Set of educational brochures/brochures which contained 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 called patients in this condition at home for a 5-15 minute session to review the brochures and discuss any questions that s(he) had.	Control n=22 participants at risk Attention Control, Limited Assessment Lifestyle brochures: Set of educational brochures/brochures which contained 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 called patients in this condition at home for a 5-15 minute session to review the brochures and discuss any questions that s(he) had.
Investigations Unable to administer part B of intervention	8.1% 3/37 • 6 months	0.00% 0/23 • 6 months	0.00% 0/22 • 6 months
Psychiatric disorders Participant became alcohol dependent	2.7% 1/37 • 6 months	0.00% 0/23 • 6 months	0.00% 0/22 • 6 months
General disorders Participant entered palliative care	2.7% 1/37 • 6 months	0.00% 0/23 • 6 months	0.00% 0/22 • 6 months

Additional Information

Lauren M. Broyles, PhD, RN

VA Pittsburgh Healthcare System

Phone: 412-360-2269

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place