A Critical Illness Recovery Navigator for Alcohol

Alcohol Use Disorder (AUD) Clinical Trial

— CIRNA  

Official title:

A Critical Illness Recovery Navigator for Alcohol: a Pilot Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03059082
• Other study ID #: 16-2094
• Status: Terminated
• Phase: N/A
• Start date: December 2016
• Est. completion date: August 31, 2018

Study information

• Verified date: November 2019
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 47
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Use Disorder (AUD)
• Alcoholism
• Critical Illness

Intervention

Behavioral:
• Recovery Navigator on an as needed basis up to 6 months
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.
• Recovery Navigator prior to hospital discharge
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.

Other:
• No interaction with Recovery Navigator
This group will not have any interaction with Recovery Navigator. They will have a 3 month and 6 month follow-up visit.

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Client Satisfaction and Acceptability of study	Client satisfaction questionnaire (CSQ-8), with revisions to make it specific to the objectives of this study.	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	Subject Dropout Rates	The percentage of subjects who do not show up for study visits calculated for each arm of the study.	3 and 6 months
Secondary	Subjects with at least one visit after discharge	The percentage of subjects with at least one visit after discharge with the navigator.	6 months
Secondary	Time per subject visit	The amount of time per subject visit to determine feasibility of the intervention for a larger study.	6 months
Secondary	Number of visits	the Number of visits total to help determine feasibility of the intervention for a larger study.	6 months.
Secondary	Initiation of treatment within 14 days.	Initiation of treatment by attendance at one treatment session within 14 days as efficacy measure for larger trial.	14 days
Secondary	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	6 months
Secondary	Engagement in alcohol/drug treatment	2 or more inpatient admissions, outpatient visits, intensive outpatient encounters or partial hospitalizations as efficacy measure for larger trial	3 and 6 months
Secondary	Completion of alcohol/drug treatment	Completion of alcohol treatment program as efficacy measure for larger trial	3 and 6 months
Secondary	Hospital re admissions and emergency department visits	Number of hospital readmission and emergency department visits as efficacy measure for larger trial	3 and 6 months
Secondary	Receipt of treatment for drug problems	Receipt of treatment for drug problems as efficacy measure for larger trial.	3 and 6 months
Secondary	Receipt of psychiatric treatment.	Receipt of psychiatric treatment as efficacy measure for larger trial.	3 and 6 months
Secondary	Number of days abstained from alcohol consumption	Percentage of days abstinent from alcohol consumption in 30 day timeframe	30 days
Secondary	Number of days with reported heavy alcohol consumption	Percentage of days with reported heavy alcohol consumption in 30 day timeframe	30 days
Secondary	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	6 months
Secondary	Alcohol related problems measured by SIP-2R	alcohol related problems assessed by administering the Short Inventory of Problems 2, revised (SIP-2R).	3 and 6 months
Secondary	HADS anxiety assessment	Anxiety assessed with 14 item Hospital Anxiety and Depression Scale (HADS).	3 and 6 months
Secondary	HADS depression assessment	Depression assessed with 14 item Hospital Anxiety and Depression Scale (HADS).	3 and 6 months
Secondary	Post Traumatic Stress Disorder (PTSD) symptoms	PTSD symptoms assessed using the Impact of Events Scale, revised.	3 and 6 months.