A Critical Illness Recovery Navigator for Alcohol

NCT ID: NCT03059082

Last Updated: 2019-11-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2018-08-31

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: OTHER

Recovery Navigator on an as needed basis up to 6 months

Intervention Type: 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.

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.

Group Type: OTHER

Recovery Navigator prior to hospital discharge

Intervention Type: 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.

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.

Group Type: OTHER

No interaction with Recovery Navigator

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Other Intervention Names

Recovery Navigator; Recovery Navigator; Control

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brendan J Clark, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado

Aurora, Colorado, United States

Countries

United States

Other Identifiers

16-2094

Identifier Type: -

Identifier Source: org_study_id