Excessive alcohol consumption is common in patients admitted to the intensive care unit (ICU). Among patients who survive an ICU admission, excessive alcohol consumption is associated with a higher risk of being admitted the hospital. In this study, the Investigators will compare an intervention designed to address excessive drinking in ICU survivors to usual care. This intervention combines motivational interviewing (MI) and shared decision making (SDM). MI and SDM share several core components including the development of a therapeutic alliance and promotion of autonomy. MI can be employed in the context of motivating a patient to change their drinking. Once this decision has been made, SDM can be employed to help a patient decide amongst multiple reasonable treatment options. The Investigators long-term goal is to test whether MI-SDM is better than usual care and whether multiple sessions of MI-SDM are better than a single session. This pilot clinical trial will demonstrate the feasibility of conducting a larger efficacy study to test these hypotheses.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
47
This group will undergo contact with Recovery Navigator on an "as needed basis" up to 6 months and then have a 3 month and 6 month follow-up visit.
This group will undergo one interaction with Recovery Navigator prior to hospital discharge and then have a 3 month and 6 month follow-up visit.
This group will not have any interaction with Recovery Navigator. They will have a 3 month and 6 month follow-up visit.
University of Colorado
Aurora, Colorado, United States
Client Satisfaction and Acceptability of study
Client satisfaction questionnaire (CSQ-8), with revisions to make it specific to the objectives of this study.
Time frame: 6 months
Subject Recruitment Rate
The following will be collected to determine the feasibility and design of a larger effectiveness study: recruitment rates calculated as the number of patients recruited per month per hospital.
Time frame: 6 months
Subject willingness to be randomized
The number of patients who refuse study participation due to refusal to undergo randomization. This will be collected to inform the feasibility and design of a larger effectiveness study.
Time frame: 6 months
Subject Dropout Rates
The percentage of subjects who do not show up for study visits calculated for each arm of the study.
Time frame: 3 and 6 months
Subjects with at least one visit after discharge
The percentage of subjects with at least one visit after discharge with the navigator.
Time frame: 6 months
Time per subject visit
The amount of time per subject visit to determine feasibility of the intervention for a larger study.
Time frame: 6 months
Number of visits
the Number of visits total to help determine feasibility of the intervention for a larger study.
Time frame: 6 months.
Initiation of treatment within 14 days.
Initiation of treatment by attendance at one treatment session within 14 days as efficacy measure for larger trial.
Time frame: 14 days
Initiation of alcohol/drug treatment within 6 months
Initiation of treatment by attendance at one treatment session within 6 months as efficacy measure for larger trial
Time frame: 6 months
Engagement in alcohol/drug treatment
2 or more inpatient admissions, outpatient visits, intensive outpatient encounters or partial hospitalizations as efficacy measure for larger trial
Time frame: 3 and 6 months
Completion of alcohol/drug treatment
Completion of alcohol treatment program as efficacy measure for larger trial
Time frame: 3 and 6 months
Hospital re admissions and emergency department visits
Number of hospital readmission and emergency department visits as efficacy measure for larger trial
Time frame: 3 and 6 months
Receipt of treatment for drug problems
Receipt of treatment for drug problems as efficacy measure for larger trial.
Time frame: 3 and 6 months
Receipt of psychiatric treatment.
Receipt of psychiatric treatment as efficacy measure for larger trial.
Time frame: 3 and 6 months
Number of days abstained from alcohol consumption
Percentage of days abstinent from alcohol consumption in 30 day timeframe
Time frame: 30 days
Number of days with reported heavy alcohol consumption
Percentage of days with reported heavy alcohol consumption in 30 day timeframe
Time frame: 30 days
Phosphatidylethanol (PEth) level at 6 months
Phosphatidylethanol (PEth) level at 6 months compared against subject's self-reported alcohol consumption and measured by United States Drug Testing laboratory
Time frame: 6 months
Alcohol related problems measured by SIP-2R
alcohol related problems assessed by administering the Short Inventory of Problems 2, revised (SIP-2R).
Time frame: 3 and 6 months
HADS anxiety assessment
Anxiety assessed with 14 item Hospital Anxiety and Depression Scale (HADS).
Time frame: 3 and 6 months
HADS depression assessment
Depression assessed with 14 item Hospital Anxiety and Depression Scale (HADS).
Time frame: 3 and 6 months
Post Traumatic Stress Disorder (PTSD) symptoms
PTSD symptoms assessed using the Impact of Events Scale, revised.
Time frame: 3 and 6 months.
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