Clinical trial NCT03059082: A Critical Illness Recovery Navigator for Alcohol
Official title: A Critical Illness Recovery Navigator for Alcohol: a Pilot Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Alcohol Use Disorder (AUD)
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Admission to the intensive care unit;
2. Age 18 years or older;
3. Resolution of critical illness, defined as the intention of the treating team to discharge the patient or downgrade their admission level from the ICU to a progressive care unit or the floor;
4. Resolution of delirium, defined by:

   * a Riker Agitation Sedation Scale score of 0,
   * a negative CAM ICU, and
   * confirmation from the treating team (nurse, physicians) that the patient is not delirious.
5. AUDIT-C score of 3 or greater for women and 4 or greater for men.

Exclusion Criteria:

1. Prisoner;
2. Pregnant;
3. Unable to speak or write in English;
4. Unable to provide informed consent;
5. Unable to provide a home or cell phone number plus at least one additional way to be contacted (mail, email, friend or family);
6. Expected survival less than 6 months.

Primary outcomes:
measure: Client Satisfaction and Acceptability of study
timeFrame: 6 months
Secondary outcomes:
measure: Subject Recruitment Rate
timeFrame: 6 months
measure: Subject willingness to be randomized
timeFrame: 6 months
measure: Subject Dropout Rates
timeFrame: 3 and 6 months
measure: Subjects with at least one visit after discharge
timeFrame: 6 months
measure: Time per subject visit
timeFrame: 6 months
measure: Number of visits
timeFrame: 6 months.
measure: Initiation of treatment within 14 days.
timeFrame: 14 days
measure: Initiation of alcohol/drug treatment within 6 months
timeFrame: 6 months
measure: Engagement in alcohol/drug treatment
timeFrame: 3 and 6 months
measure: Completion of alcohol/drug treatment
timeFrame: 3 and 6 months
measure: Hospital re admissions and emergency department visits
timeFrame: 3 and 6 months
measure: Receipt of treatment for drug problems
timeFrame: 3 and 6 months
measure: Receipt of psychiatric treatment.
timeFrame: 3 and 6 months
measure: Number of days abstained from alcohol consumption
timeFrame: 30 days
measure: Number of days with reported heavy alcohol consumption
timeFrame: 30 days
measure: Phosphatidylethanol (PEth) level at 6 months
timeFrame: 6 months
measure: Alcohol related problems measured by SIP-2R
timeFrame: 3 and 6 months
measure: HADS anxiety assessment
timeFrame: 3 and 6 months
measure: HADS depression assessment
timeFrame: 3 and 6 months
measure: Post Traumatic Stress Disorder (PTSD) symptoms
timeFrame: 3 and 6 months.
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Brendan J Clark, MD
role: PRINCIPAL_INVESTIGATOR
References: