A Critical Illness Recovery Navigator for Alcohol (CIRNA)

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

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 Overview

• Status: Terminated
• Conditions: Alcohol Use Disorder (AUD)
• Intervention / Treatment: Behavioral: Recovery Navigator on an as needed basis up to 6 months; Behavioral: Recovery Navigator prior to hospital discharge; Other: No interaction with Recovery Navigator

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Continued Interaction; This group will undergo contact with Recovery Navigator on an "as needed basis" up to 6 months.They will then have a 3 month and 6 month follow up visit with the PI. There is no drug or treatment administered to the subject. The intervention is the conversation/contact with the Recovery Navigator, in this arm, it is continued throughout the study. Note: The first 10 subjects will not be randomized and will be assigned to this Arm. The purpose of this is to ensure the fidelity of the intervention. The remaining 60 subjects will be randomized equally among the three Arms. Data from the first 10 subjects will not be considered for the outcome measures.	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.; Other Names: Recovery Navigator
Other: Single interaction; This group will undergo one interaction with the Recovery Navigator prior to the hospital discharge. They will then have a 3 month and 6 month follow up visit with the PI. There is no drug or treatment administered to the subject.The intervention is the conversation/contact with the Recovery Navigator, in this arm, it is conducted once.	Behavioral: 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 Names: Recovery Navigator
Other: Control; This group will not have any interaction with the Recovery Navigator. They will then have a 3 month and 6 month follow up visit. There is no drug or treatment administered to the subject.	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.; Other Names: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Subjects with at least one visit after discharge	The percentage of subjects with at least one visit after discharge with the navigator.	6 months
Time per subject visit	The amount of time per subject visit to determine feasibility of the intervention for a larger study.	6 months
Number of visits	the Number of visits total to help determine feasibility of the intervention for a larger study.	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.	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	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	3 and 6 months
Completion of alcohol/drug treatment	Completion of alcohol treatment program as efficacy measure for larger trial	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	3 and 6 months
Receipt of treatment for drug problems	Receipt of treatment for drug problems as efficacy measure for larger trial.	3 and 6 months
Receipt of psychiatric treatment.	Receipt of psychiatric treatment as efficacy measure for larger trial.	3 and 6 months
Number of days abstained from alcohol consumption	Percentage of days abstinent from alcohol consumption in 30 day timeframe	30 days
Number of days with reported heavy alcohol consumption	Percentage of days with reported heavy alcohol consumption in 30 day timeframe	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	6 months
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
HADS anxiety assessment	Anxiety assessed with 14 item Hospital Anxiety and Depression Scale (HADS).	3 and 6 months
HADS depression assessment	Depression assessed with 14 item Hospital Anxiety and Depression Scale (HADS).	3 and 6 months
Post Traumatic Stress Disorder (PTSD) symptoms	PTSD symptoms assessed using the Impact of Events Scale, revised.	3 and 6 months.

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Brendan J Clark, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Actual): August 31, 2018
• Study Completion (Actual): August 31, 2018

Study Registration Dates

• First Submitted: January 3, 2017
• First Submitted That Met QC Criteria: February 15, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): November 21, 2019
• Last Update Submitted That Met QC Criteria: November 19, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Alcohol-Related Disorders; Substance-Related Disorders; Disease Attributes; Alcoholism; Critical Illness
• Other Study ID Numbers: 16-2094

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No