Improving Outcomes Among Medical/Surgical Inpatients With Alcohol Use Disorders

• ClinicalTrials.gov Identifier: NCT03258632
• Recruitment Status: Completed
• First Posted: August 23, 2017
• Results First Posted: April 17, 2024
• Last Update Posted: April 17, 2024
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Health Services Research
• Condition: Alcohol Use Disorder
• Intervention: Behavioral: Drinking Options - Motivate, Shared Decisions, Telemonitor (DO-MoST)
• Enrollment: 155

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Usual Care	Intervention
Arm/Group Description	Under usual care, when a patient screens positive on the AUDIT-C administered at intake, a provider (social worker, nurse) provides Brief Intervention (BI), i.e., tells the patient that problems are associated with alcohol use, and about recommended drinking limits; notes the patient as ready to change drinking or not, and as agreeing to treatment or not. If the patient agrees to treatment, specialty addiction services are notified.	Patients will attend one 50-minute individual session with a Decision Coach (a trained clinical provider, e.g., MSW). Patients in DO-MoST will also attend 6 biweekly 15-minute telephone sessions from the same Decision Coach. Drinking Options - Motivate, Shared Decisions, Telemonitor (DO-MoST): Patients will attend one 50-minute individual session with a Decision Coach (a trained clinical provider, e.g., MSW). Patients in DO-MoST will also attend 6 biweekly 15-minute telephone sessions from the same Decision Coach.
Period Title: Overall Study
Started	82	73
Completed	70	60
Not Completed	12	13

Baseline Characteristics

Arm/Group Title		Usual Care	Intervention	Total
Arm/Group Description		Under usual care, when a patient screens positive on the AUDIT-C administered at intake, a provider (social worker, nurse) provides Brief Intervention (BI), i.e., tells the patient that problems are associated with alcohol use, and about recommended drinking limits; notes the patient as ready to change drinking or not, and as agreeing to treatment or not. If the patient agrees to treatment, specialty addiction services are notified.	Patients will attend one 50-minute individual session with a Decision Coach (a trained clinical provider, e.g., MSW). Patients in DO-MoST will also attend 6 biweekly 15-minute telephone sessions from the same Decision Coach. Drinking Options - Motivate, Shared Decisions, Telemonitor (DO-MoST): Patients will attend one 50-minute individual session with a Decision Coach (a trained clinical provider, e.g., MSW). Patients in DO-MoST will also attend 6 biweekly 15-minute telephone sessions from the same Decision Coach.	Total of all reporting groups
Overall Number of Baseline Participants		82	73	155
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	82 participants	73 participants	155 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	47 57.3%	45 61.6%	92 59.4%
	>=65 years	35 42.7%	28 38.4%	63 40.6%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	82 participants	73 participants	155 participants
		59.4 (14.7)	59.5 (12.6)	59.4 (13.7)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	82 participants	73 participants	155 participants
	Female	6 7.3%	6 8.2%	12 7.7%
	Male	76 92.7%	67 91.8%	143 92.3%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	82 participants	73 participants	155 participants
	American Indian or Alaska Native	0 0.0%	5 6.8%	5 3.2%
	Asian	2 2.4%	0 0.0%	2 1.3%
	Native Hawaiian or Other Pacific Islander	2 2.4%	0 0.0%	2 1.3%
	Black or African American	10 12.2%	6 8.2%	16 10.3%
	White	49 59.8%	49 67.1%	98 63.2%
	More than one race	10 12.2%	11 15.1%	21 13.5%
	Unknown or Not Reported	9 11.0%	2 2.7%	11 7.1%
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants
United States	Number Analyzed	82 participants	73 participants	155 participants
		82 100.0%	73 100.0%	155 100.0%

Outcome Measures

1. Primary Outcome

Title	Time Line Follow Back
Description	The investigators will use the Timeline Follow-Back (TLFB) to assess abstinence from alcohol use during the 30 days preceding assessment. The TLFB is a widely used, standardized, calendar-based retrospective self-report assessment to quantify daily alcohol use. The investigators will examine the primary outcome of abstinence from alcohol use at 12-month follow-up.
Time Frame	Alcohol use in the past 30 days, assessed at 12-month follow-up

Outcome Measure Data

Analysis Population Description

Participants who completed follow-up.

Arm/Group Title	Usual Care	Intervention
Arm/Group Description:	Under usual care, when a patient screens positive on the AUDIT-C administered at intake, a provider (social worker, nurse) provides Brief Intervention (BI), i.e., tells the patient that problems are associated with alcohol use, and about recommended drinking limits; notes the patient as ready to change drinking or not, and as agreeing to treatment or not. If the patient agrees to treatment, specialty addiction services are notified.	Patients will attend one 50-minute individual session with a Decision Coach (a trained clinical provider, e.g., MSW). Patients in DO-MoST will also attend 6 biweekly 15-minute telephone sessions from the same Decision Coach. Drinking Options - Motivate, Shared Decisions, Telemonitor (DO-MoST): Patients will attend one 50-minute individual session with a Decision Coach (a trained clinical provider, e.g., MSW). Patients in DO-MoST will also attend 6 biweekly 15-minute telephone sessions from the same Decision Coach.
Overall Number of Participants Analyzed	66	60
Measure Type: Number; Unit of Measure: percentage of participants abstinent
	48	56

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Intervention
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.05
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.17
	Confidence Interval	(2-Sided) 95%; 0.73 to 1.90
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	Utilization of Substance Use-related Care
Description	The investigators used a TLFB approach to assess utilization of substance use-related care (any receipt of outpatient and/or residential treatment for alcohol and/or drug problems, yes or no) between baseline and the 12-month follow-up.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Consented participants

Arm/Group Title	Usual Care	Intervention
Arm/Group Description:	Randomly assigned to usual care	Randomly assigned to DO-MoST
Overall Number of Participants Analyzed	66	60
Measure Type: Count of Participants; Unit of Measure: Participants
	21 31.8%	6 10.0%

Adverse Events

Time Frame	Adverse event data were collected from the time of study entry until the end of planned study participation which was 12 months.
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Usual Care		Intervention
Arm/Group Description	Under usual care, when a patient screens positive on the AUDIT-C administered at intake, a provider (social worker, nurse) provides Brief Intervention (BI), i.e., tells the patient that problems are associated with alcohol use, and about recommended drinking limits; notes the patient as ready to change drinking or not, and as agreeing to treatment or not. If the patient agrees to treatment, specialty addiction services are notified.		Patients will attend one 50-minute individual session with a Decision Coach (a trained clinical provider, e.g., MSW). Patients in DO-MoST will also attend 6 biweekly 15-minute telephone sessions from the same Decision Coach. Drinking Options - Motivate, Shared Decisions, Telemonitor (DO-MoST): Patients will attend one 50-minute individual session with a Decision Coach (a trained clinical provider, e.g., MSW). Patients in DO-MoST will also attend 6 biweekly 15-minute telephone sessions from the same Decision Coach.
All-Cause Mortality
	Usual Care		Intervention
	Affected / at Risk (%)		Affected / at Risk (%)
Total	5/82 (6.10%)		3/73 (4.11%)
Serious Adverse Events
	Usual Care		Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	19/82 (23.17%)		10/73 (13.70%)
Surgical and medical procedures
Hospitalization †	19/82 (23.17%)	19	10/73 (13.70%)	10
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Usual Care		Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/82 (0.00%)		0/73 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Christine Timko
• Organization: Department of Veterans Affairs
• Phone: 650-493-5000 ext 23336
• EMail: Christine.Timko@va.gov

Publications of Results:

Timko C, Lewis M, Lor MC, Aldaco-Revilla L, Blonigen D, Ilgen M. Hazardous Drinking Interventions Delivered During Medical-Surgical Care: Patient and Provider Views. J Clin Psychol Med Settings. 2024 Mar;31(1):224-235. doi: 10.1007/s10880-023-09954-4. Epub 2023 Mar 23.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT03258632
• Other Study ID Numbers: IIR 15-298
• First Submitted: August 15, 2017
• First Posted: August 23, 2017
• Results First Submitted: February 24, 2023
• Results First Posted: April 17, 2024
• Last Update Posted: April 17, 2024