Alcohol Use Disorder (AUD)CIRNANCT03059082
A Critical Illness Recovery Navigator for Alcohol
A study testing Recovery Navigator on an as needed basis up to 6 months, Recovery Navigator prior to hospital discharge and No interaction with Recovery Navigator in people with Alcohol Use Disorder (AUD), run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder (AUD)
- What is being tested?
- Recovery Navigator on an as needed basis up to 6 months, Recovery Navigator prior to hospital discharge and No interaction with Recovery Navigator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to 31 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Alcohol Use Disorder (AUD)
- Being tested
- Recovery Navigator on an as needed basis up to 6 months, Recovery Navigator prior to hospital discharge, No interaction with Recovery Navigator
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recovery Navigator on an as needed basis up to 6 monthsBehavioural
Also called Recovery Navigator
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.
Recovery Navigator prior to hospital dischargeBehavioural
Also called Recovery Navigator
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.
No interaction with Recovery NavigatorOther
Also called Control
This group will not have any interaction with Recovery Navigator. They will have a 3 month and 6 month follow-up visit.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: No interaction with Recovery Navigator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Client Satisfaction and Acceptability of study
Client satisfaction questionnaire (CSQ-8), with revisions to make it specific to the objectives of this study.
Measured: 6 months
Secondary outcomes (20)
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.
Measured: 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.
Measured: 6 months
Subject Dropout Rates
The percentage of subjects who do not show up for study visits calculated for each arm of the study.
Measured: 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.
Measured: 6 months
Time per subject visit
The amount of time per subject visit to determine feasibility of the intervention for a larger study.
Measured: 6 months
Number of visits
the Number of visits total to help determine feasibility of the intervention for a larger study.
Measured: 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.
Measured: 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
Measured: 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
Measured: 3 and 6 months
Completion of alcohol/drug treatment
Completion of alcohol treatment program as efficacy measure for larger trial
Measured: 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
Measured: 3 and 6 months
Receipt of treatment for drug problems
Receipt of treatment for drug problems as efficacy measure for larger trial.
Measured: 3 and 6 months
Receipt of psychiatric treatment.
Receipt of psychiatric treatment as efficacy measure for larger trial.
Measured: 3 and 6 months
Number of days abstained from alcohol consumption
Percentage of days abstinent from alcohol consumption in 30 day timeframe
Measured: 30 days
Number of days with reported heavy alcohol consumption
Percentage of days with reported heavy alcohol consumption in 30 day timeframe
Measured: 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
Measured: 6 months
Alcohol related problems measured by SIP-2R
alcohol related problems assessed by administering the Short Inventory of Problems 2, revised (SIP-2R).
Measured: 3 and 6 months
HADS anxiety assessment
Anxiety assessed with 14 item Hospital Anxiety and Depression Scale (HADS).
Measured: 3 and 6 months
HADS depression assessment
Depression assessed with 14 item Hospital Anxiety and Depression Scale (HADS).
Measured: 3 and 6 months
Post Traumatic Stress Disorder (PTSD) symptoms
PTSD symptoms assessed using the Impact of Events Scale, revised.
Measured: 3 and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study startDec 2016
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Why it stopped: Principal Investigator surrendered funding and left institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use Disorder (AUD)Studies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brendan J Clark, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03059082
- Sponsor's protocol ID
- 16-2094
- Acronym
- CIRNA
- Status last verified
- Nov 2019
- First submitted
- 3 Jan 2017
- Last updated
- 21 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Critical Illness Recovery Navigator for Alcohol: a Pilot Clinical Trial
- ClinicalTrials.gov ID
- NCT03059082
- Acronym / sponsor ID
- CIRNA / 16-2094
- Conditions
- Alcohol Use Disorder (AUD)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal Investigator surrendered funding and left institution.
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Continued Interaction | Other | Behavioral: Recovery Navigator on an as needed basis up to 6 monthsThis 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 | Other | Behavioral: Recovery Navigator prior to hospital dischargeThis 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 | Other | Other: No interaction with Recovery NavigatorThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- AUDIT-C score of 3 or greater for women and 4 or greater for men.
Key exclusion criteria (6 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recovery Navigator on an as needed basis up to 6 monthsAlso: Recovery NavigatorThis 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. | Behavioural | Continued Interaction |
| Recovery Navigator prior to hospital dischargeAlso: Recovery NavigatorThis group will undergo one interaction with Recovery Navigator prior to hospital discharge and then have a 3 month and 6 month follow-up visit. | Behavioural | Single interaction |
| No interaction with Recovery NavigatorAlso: ControlThis group will not have any interaction with Recovery Navigator. They will have a 3 month and 6 month follow-up visit. | Other | Control |
Primary outcome
Client Satisfaction and Acceptability of study
Time frame: 6 months
Client satisfaction questionnaire (CSQ-8), with revisions to make it specific to the objectives of this study.
20 secondary outcomes
Subject Recruitment Rate
Time frame: 6 months
Subject willingness to be randomized
Time frame: 6 months
Subject Dropout Rates
Time frame: 3 and 6 months
Subjects with at least one visit after discharge
Time frame: 6 months
Time per subject visit
Time frame: 6 months
Number of visits
Time frame: 6 months.
Initiation of treatment within 14 days.
Time frame: 14 days
Initiation of alcohol/drug treatment within 6 months
Time frame: 6 months
Engagement in alcohol/drug treatment
Time frame: 3 and 6 months
Completion of alcohol/drug treatment
Time frame: 3 and 6 months
Hospital re admissions and emergency department visits
Time frame: 3 and 6 months
Receipt of treatment for drug problems
Time frame: 3 and 6 months
Receipt of psychiatric treatment.
Time frame: 3 and 6 months
Number of days abstained from alcohol consumption
Time frame: 30 days
Number of days with reported heavy alcohol consumption
Time frame: 30 days
Phosphatidylethanol (PEth) level at 6 months
Time frame: 6 months
Alcohol related problems measured by SIP-2R
Time frame: 3 and 6 months
HADS anxiety assessment
Time frame: 3 and 6 months
HADS depression assessment
Time frame: 3 and 6 months
Post Traumatic Stress Disorder (PTSD) symptoms
Time frame: 3 and 6 months.
Results and safety
The study was stopped early (reason given: Principal Investigator surrendered funding and left institution.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brendan J Clark, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recovery Navigator on an as needed basis up to 6 months, Recovery Navigator prior to hospital discharge and No interaction with Recovery Navigator in people with Alcohol Use Disorder (AUD), run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Principal Investigator surrendered funding and left institution.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Client Satisfaction and Acceptability of study (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2019.