A Critical Illness Recovery Navigator for Alcohol

Not Applicable

Terminated

• Conditions: Alcohol Use Disorder (AUD)
• Interventions: 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

• Registration Number: NCT03059082
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2017-01-03
• Study First Submitted QC: 2017-02-15
• Study First Posted: 2017-02-23
• Primary Completion: 2018-08-31
• Study Completion: 2018-08-31
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-19
• Last Update Posted: 2019-11-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 47

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continued Interaction	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.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.
Single interaction	Recovery Navigator prior to hospital discharge	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.
Control	No interaction with Recovery Navigator	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.

Primary Outcome Measures

Name	Time	Method
Client Satisfaction and Acceptability of study	6 months	Client satisfaction questionnaire (CSQ-8), with revisions to make it specific to the objectives of this study.

Secondary Outcome Measures

Name	Time	Method
Engagement in alcohol/drug treatment	3 and 6 months	2 or more inpatient admissions, outpatient visits, intensive outpatient encounters or partial hospitalizations as efficacy measure for larger trial
Completion of alcohol/drug treatment	3 and 6 months	Completion of alcohol treatment program as efficacy measure for larger trial
Subject Recruitment Rate	6 months	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.
Subject willingness to be randomized	6 months	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.
Subject Dropout Rates	3 and 6 months	The percentage of subjects who do not show up for study visits calculated for each arm of the study.
Subjects with at least one visit after discharge	6 months	The percentage of subjects with at least one visit after discharge with the navigator.
Time per subject visit	6 months	The amount of time per subject visit to determine feasibility of the intervention for a larger study.
Number of visits	6 months.	the Number of visits total to help determine feasibility of the intervention for a larger study.
Initiation of treatment within 14 days.	14 days	Initiation of treatment by attendance at one treatment session within 14 days as efficacy measure for larger trial.
Initiation of alcohol/drug treatment within 6 months	6 months	Initiation of treatment by attendance at one treatment session within 6 months as efficacy measure for larger trial
Hospital re admissions and emergency department visits	3 and 6 months	Number of hospital readmission and emergency department visits as efficacy measure for larger trial
Receipt of treatment for drug problems	3 and 6 months	Receipt of treatment for drug problems as efficacy measure for larger trial.
Receipt of psychiatric treatment.	3 and 6 months	Receipt of psychiatric treatment as efficacy measure for larger trial.
Number of days abstained from alcohol consumption	30 days	Percentage of days abstinent from alcohol consumption in 30 day timeframe
Number of days with reported heavy alcohol consumption	30 days	Percentage of days with reported heavy alcohol consumption in 30 day timeframe
Phosphatidylethanol (PEth) level at 6 months	6 months	Phosphatidylethanol (PEth) level at 6 months compared against subject's self-reported alcohol consumption and measured by United States Drug Testing laboratory
Alcohol related problems measured by SIP-2R	3 and 6 months	alcohol related problems assessed by administering the Short Inventory of Problems 2, revised (SIP-2R).
HADS anxiety assessment	3 and 6 months	Anxiety assessed with 14 item Hospital Anxiety and Depression Scale (HADS).
HADS depression assessment	3 and 6 months	Depression assessed with 14 item Hospital Anxiety and Depression Scale (HADS).
Post Traumatic Stress Disorder (PTSD) symptoms	3 and 6 months.	PTSD symptoms assessed using the Impact of Events Scale, revised.

Trial Locations

Locations (1)

University of Colorado; 🇺🇸 Aurora, Colorado, United States