A Critical Illness Recovery Navigator for Alcohol: a Pilot Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Client Satisfaction and Acceptability of study
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Recovery Navigator on an as needed basis up to 6 months (Behavioral)
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.
干预措施: Recovery Navigator prior to hospital discharge (Behavioral)
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.
干预措施: No interaction with Recovery Navigator (Other)
结局指标
主要结局
Client Satisfaction and Acceptability of study
时间窗: 6 months
Client satisfaction questionnaire (CSQ-8), with revisions to make it specific to the objectives of this study.
次要结局
- Hospital re admissions and emergency department visits(3 and 6 months)
- Receipt of treatment for drug problems(3 and 6 months)
- Receipt of psychiatric treatment.(3 and 6 months)
- Number of days abstained from alcohol consumption(30 days)
- Number of days with reported heavy alcohol consumption(30 days)
- Phosphatidylethanol (PEth) level at 6 months(6 months)
- Alcohol related problems measured by SIP-2R(3 and 6 months)
- HADS anxiety assessment(3 and 6 months)
- HADS depression assessment(3 and 6 months)
- Post Traumatic Stress Disorder (PTSD) symptoms(3 and 6 months.)
- Engagement in alcohol/drug treatment(3 and 6 months)
- Completion of alcohol/drug treatment(3 and 6 months)
- 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)
- Number of visits(6 months.)
- Initiation of treatment within 14 days.(14 days)
- Initiation of alcohol/drug treatment within 6 months(6 months)