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A Critical Illness Recovery Navigator for Alcohol (CIRNA)

Primary Purpose

Alcohol Use Disorder (AUD)

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Recovery Navigator on an as needed basis up to 6 months
Recovery Navigator prior to hospital discharge
No interaction with Recovery Navigator
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Alcohol Use Disorder (AUD)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Colorado

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Continued Interaction

Single interaction

Control

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
Subject Dropout Rates
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
The percentage of subjects with at least one visit after discharge with the navigator.
Time per subject visit
The amount of time per subject visit to determine feasibility of the intervention for a larger study.
Number of visits
the Number of visits total to help determine feasibility of the intervention for a larger study.
Initiation of treatment within 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
Initiation of treatment by attendance at one treatment session within 6 months as efficacy measure for larger trial
Engagement in alcohol/drug treatment
2 or more inpatient admissions, outpatient visits, intensive outpatient encounters or partial hospitalizations as efficacy measure for larger trial
Completion of alcohol/drug treatment
Completion of alcohol treatment program as efficacy measure for larger trial
Hospital re admissions and emergency department visits
Number of hospital readmission and emergency department visits as efficacy measure for larger trial
Receipt of treatment for drug problems
Receipt of treatment for drug problems as efficacy measure for larger trial.
Receipt of psychiatric treatment.
Receipt of psychiatric treatment as efficacy measure for larger trial.
Number of days abstained from alcohol consumption
Percentage of days abstinent from alcohol consumption in 30 day timeframe
Number of days with reported heavy alcohol consumption
Percentage of days with reported heavy alcohol consumption in 30 day timeframe
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
Alcohol related problems measured by SIP-2R
alcohol related problems assessed by administering the Short Inventory of Problems 2, revised (SIP-2R).
HADS anxiety assessment
Anxiety assessed with 14 item Hospital Anxiety and Depression Scale (HADS).
HADS depression assessment
Depression assessed with 14 item Hospital Anxiety and Depression Scale (HADS).
Post Traumatic Stress Disorder (PTSD) symptoms
PTSD symptoms assessed using the Impact of Events Scale, revised.

Full Information

First Posted
January 3, 2017
Last Updated
November 19, 2019
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT03059082
Brief Title
A Critical Illness Recovery Navigator for Alcohol
Acronym
CIRNA
Official Title
A Critical Illness Recovery Navigator for Alcohol: a Pilot Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Terminated
Why Stopped
Principal Investigator surrendered funding and left institution.
Study Start Date
December 2016 (undefined)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
August 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder (AUD)

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continued Interaction
Arm Type
Other
Arm Description
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.
Arm Title
Single interaction
Arm Type
Other
Arm Description
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.
Arm Title
Control
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Recovery Navigator on an as needed basis up to 6 months
Other Intervention Name(s)
Recovery Navigator
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Recovery Navigator prior to hospital discharge
Other Intervention Name(s)
Recovery Navigator
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
No interaction with Recovery Navigator
Other Intervention Name(s)
Control
Intervention Description
This group will not have any interaction with Recovery Navigator. They will have a 3 month and 6 month follow-up visit.
Primary Outcome Measure Information:
Title
Client Satisfaction and Acceptability of study
Description
Client satisfaction questionnaire (CSQ-8), with revisions to make it specific to the objectives of this study.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Subject Recruitment Rate
Description
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
Title
Subject willingness to be randomized
Description
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
Title
Subject Dropout Rates
Description
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
Title
Subjects with at least one visit after discharge
Description
The percentage of subjects with at least one visit after discharge with the navigator.
Time Frame
6 months
Title
Time per subject visit
Description
The amount of time per subject visit to determine feasibility of the intervention for a larger study.
Time Frame
6 months
Title
Number of visits
Description
the Number of visits total to help determine feasibility of the intervention for a larger study.
Time Frame
6 months.
Title
Initiation of treatment within 14 days.
Description
Initiation of treatment by attendance at one treatment session within 14 days as efficacy measure for larger trial.
Time Frame
14 days
Title
Initiation of alcohol/drug treatment within 6 months
Description
Initiation of treatment by attendance at one treatment session within 6 months as efficacy measure for larger trial
Time Frame
6 months
Title
Engagement in alcohol/drug treatment
Description
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
Title
Completion of alcohol/drug treatment
Description
Completion of alcohol treatment program as efficacy measure for larger trial
Time Frame
3 and 6 months
Title
Hospital re admissions and emergency department visits
Description
Number of hospital readmission and emergency department visits as efficacy measure for larger trial
Time Frame
3 and 6 months
Title
Receipt of treatment for drug problems
Description
Receipt of treatment for drug problems as efficacy measure for larger trial.
Time Frame
3 and 6 months
Title
Receipt of psychiatric treatment.
Description
Receipt of psychiatric treatment as efficacy measure for larger trial.
Time Frame
3 and 6 months
Title
Number of days abstained from alcohol consumption
Description
Percentage of days abstinent from alcohol consumption in 30 day timeframe
Time Frame
30 days
Title
Number of days with reported heavy alcohol consumption
Description
Percentage of days with reported heavy alcohol consumption in 30 day timeframe
Time Frame
30 days
Title
Phosphatidylethanol (PEth) level at 6 months
Description
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
Title
Alcohol related problems measured by SIP-2R
Description
alcohol related problems assessed by administering the Short Inventory of Problems 2, revised (SIP-2R).
Time Frame
3 and 6 months
Title
HADS anxiety assessment
Description
Anxiety assessed with 14 item Hospital Anxiety and Depression Scale (HADS).
Time Frame
3 and 6 months
Title
HADS depression assessment
Description
Depression assessed with 14 item Hospital Anxiety and Depression Scale (HADS).
Time Frame
3 and 6 months
Title
Post Traumatic Stress Disorder (PTSD) symptoms
Description
PTSD symptoms assessed using the Impact of Events Scale, revised.
Time Frame
3 and 6 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Admission to the intensive care unit; Age 18 years or older; 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; 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. AUDIT-C score of 3 or greater for women and 4 or greater for men. Exclusion Criteria: Prisoner; Pregnant; Unable to speak or write in English; Unable to provide informed consent; Unable to provide a home or cell phone number plus at least one additional way to be contacted (mail, email, friend or family); Expected survival less than 6 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brendan J Clark, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

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A Critical Illness Recovery Navigator for Alcohol

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