A Critical Illness Recovery Navigator for Alcohol

NCT03059082 | Terminated

• 1 other identifier: 16-2094
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorder (AUD)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• Subject Recruitment Rate

  6 months

• Subject willingness to be randomized

  6 months

• Subject Dropout Rates

  3 and 6 months

• Subjects with at least one visit after discharge

  6 months

• Time per subject visit

  6 months

Study Arms (3)

Continued Interaction

OTHER

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

Single interaction

OTHER

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

Control

OTHER

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

Interventions

Recovery Navigator on an as needed basis up to 6 months BEHAVIORAL

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.

Also known as: Recovery Navigator

Continued Interaction

Recovery Navigator prior to hospital discharge BEHAVIORAL

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.

Also known as: Recovery Navigator

Single interaction

No interaction with Recovery Navigator OTHER

This group will not have any interaction with Recovery Navigator. They will have a 3 month and 6 month follow-up visit.

Also known as: Control

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Brendan J Clark, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2017
• First Posted: February 23, 2017
• Study Start: December 1, 2016
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: November 21, 2019

Record last verified: 2019-11

Locations

US (1)