Trial Outcomes & Findings for Improving Outcomes Among Medical/Surgical Inpatients With Alcohol Use Disorders (NCT NCT03258632)

Last Updated: 2024-04-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

155 participants

Primary outcome timeframe

Alcohol use in the past 30 days, assessed at 12-month follow-up

Results posted on

2024-04-17

Participant Flow

Participant milestones

Participant milestones
Measure	Usual Care 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.	Intervention 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 Study STARTED	82	73
Overall Study COMPLETED	70	60
Overall Study NOT COMPLETED	12	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Improving Outcomes Among Medical/Surgical Inpatients With Alcohol Use Disorders

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care n=82 Participants 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.	Intervention n=73 Participants 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 n=155 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	47 Participants n=5 Participants	45 Participants n=7 Participants	92 Participants n=5 Participants
Age, Categorical >=65 years	35 Participants n=5 Participants	28 Participants n=7 Participants	63 Participants n=5 Participants
Age, Continuous	59.4 years STANDARD_DEVIATION 14.7 • n=5 Participants	59.5 years STANDARD_DEVIATION 12.6 • n=7 Participants	59.4 years STANDARD_DEVIATION 13.7 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	76 Participants n=5 Participants	67 Participants n=7 Participants	143 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) White	49 Participants n=5 Participants	49 Participants n=7 Participants	98 Participants n=5 Participants
Race (NIH/OMB) More than one race	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants	2 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment United States	82 Participants n=5 Participants	73 Participants n=7 Participants	155 Participants n=5 Participants

PRIMARY outcome

Timeframe: Alcohol use in the past 30 days, assessed at 12-month follow-up

Population: Participants who completed follow-up.

Outcome measures

Outcome measures
Measure	Usual Care n=66 Participants 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.	Intervention n=60 Participants 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.
Time Line Follow Back	48 percentage of participants abstinent	56 percentage of participants abstinent

SECONDARY outcome

Timeframe: 12 months

Population: Consented participants

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.

Outcome measures

Outcome measures
Measure	Usual Care n=66 Participants 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.	Intervention n=60 Participants 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.
Utilization of Substance Use-related Care	21 Participants	6 Participants

Adverse Events

Usual Care

Serious events: 19 serious events

Other events: 0 other events

Deaths: 5 deaths

Intervention

Serious events: 10 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Usual Care n=82 participants at risk 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.	Intervention n=73 participants at risk 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.
Surgical and medical procedures Hospitalization	23.2% 19/82 • Number of events 19 • Adverse event data were collected from the time of study entry until the end of planned study participation which was 12 months.	13.7% 10/73 • Number of events 10 • Adverse event data were collected from the time of study entry until the end of planned study participation which was 12 months.

Other adverse events

Adverse event data not reported

Additional Information

Christine Timko

Department of Veterans Affairs

Phone: 650-493-5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place