Anxiety, Behavioral Health Concerns, Collaborative Care, Critical Illness, Critical Illness Recovery, Depression - Major Depressive Disorder, PICS, Post-Traumatic Stress, PTSD
Conditions
Keywords
critical illness, post-ICU, PICS, anxiety, depression, PTSD, collaborative care model, behavioral health
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALBehavioral Health Collaborative Care Model
behavioral health collaborative care model in ICU recovery patients and families
Sponsors
Medical University of South Carolina
Health Resources and Services Administration (HRSA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Attendance at the MUSC ICU Recovery Clinic within 180 days of discharge from the hospital
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression | 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 | 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 | 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). |
Countries
United States
Contacts
CONTACTRita Bakhru, MD
PRINCIPAL_INVESTIGATORRita Bakhru, MD
Medical University of South Carolina
Outcome results
None listed