Integration of a Behavioral Health Collaborative Care Model Into an ICU Recovery Clinic
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Depression
研究概览
简要总结
Survivors of critical illness are at high risk for mental health issues such as anxiety, depression, and PTSD. This single-site, randomized controlled trial at the Medical University of South Carolina will enroll 150 patients to compare outcomes between a behavioral health Collaborative Care Model (BH CoCM) and usual care (attention control). The intervention includes digital tools (Neuroflow), behavioral health coaching, and psychiatric support.
详细描述
Patients seen in the MUSC ICU Recovery Clinic will be approached for consent for enrollment. Patients that consent will be randomized to an attention control group or an intervention group.
The intervention group receive BH CoCM. They will have access to NeuroFlow platform, which has been specifically designed to support delivery of a BH CoCM. They will utilize Neuroflow for 6 months. They will undergo assessments for anxiety, depression, post-traumatic stress. A behavioral manager will monitor their needs and provide behavioral health coaching and psychiatric support as needed.
The attention control group will undergo assessments for anxiety, depression, post-traumatic stress.
Investigators will look at changes over six months in intervention group compared to attention control group for patients in terms of symptoms of depression, anxiety, post-traumatic stress. Investigators will also look at adherence, BH CoCM implementation metrics, type and amount of guided content accessed in NeuroFlow. Investigators will perform qualitative surveys to understand better what patients thought about the intervention and ways in which it could be improved.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •- Attendance at the MUSC ICU Recovery Clinic within 180 days of discharge from the hospital
排除标准
- •ICU Admission was due to a primary addiction diagnosis (eg alcohol withdrawal or delirium tremens requiring ICU care)
- •Serious Mental Illness such as Schizophrenia, psychotic disorder, acute mania
- •Late Stage Dementia or Cognitive Impairment
- •Limited English or Spanish Proficiency
- •Lack of regular access to a computer, tablet or mobile device with internet access
研究组 & 干预措施
Control
Attention Control
Interventional
干预措施: Behavioral Health Collaborative Care Model (Behavioral)
结局指标
主要结局
Depression
时间窗: Enrollment to 6 months
Changes over six months in intervention group compared to attention control group for patients in terms of symptoms of depression (PHQ-9: Patient Health Questionnaire-9).
Anxiety
时间窗: enrollment to six months
Changes over six months in intervention group compared to attention control group for patients in terms of symptoms of anxiety (GAD-7: Generalized Anxiety Disorder 7)
Post-Traumatic Stress
时间窗: enrollment to six months
Changes over six months in intervention group compared to attention control group for patients in terms of symptoms of post-traumatic stress (PCL-5:Patient Health Questionnaire-9).
次要结局
未报告次要终点
研究者
Rita Bakhru
Associate Professor-Faculty
Medical University of South Carolina