Behavioral Health Collaborative Care Model in Post-ICU Clinic Family Pilot
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Behavioral Treatment.
- Who it may be relevant to
- Registry conditions: Critical Illness Recovery, Behavioral Health Concerns, Anxiety, Depression - Major Depressive Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Integration of a Behavioral Health Collaborative Care Model Into an ICU Recovery Clinic-Pilot for Families
Overview
This pilot study evaluates the feasibility and acceptability of implementing a Behavioral Health Collaborative Care Model (BH CoCM) for family members of ICU survivors. The intervention includes telehealth-enabled behavioral health assessments and access to the NeuroFlow platform. A subset of participants will undergo qualitative interviews.
Detailed description
Patients seen in the MUSC ICU Recovery Clinic will be approached for consent for care through our Behavioral Health Collaborative Care Model. Patients and their families that consent will be randomized to an attention control group or an intervention group.
The intervention group 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 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
- Behavioral Behavioral Treatment
behavioral health collaborative care model in ICU recovery patients and families
Primary outcome measures
- Consent Rate [Time frame: Baseline]
- Study Completion Rate [Time frame: enrollment to 6 months]
Secondary outcome measures (3)
- Monthly Completion Rate of PHQ9 (Patient Health Questionnaire 9) [Time frame: Enrollment to 6 months]
- Monthly Completion Rate of GAD 7 (General Anxiety Disorder 7) [Time frame: baseline to 6 months]
- Monthly Completion Rate of PCL 5 (PTSD Checklist for DSM-5) [Time frame: baseline to 6 months]
Eligibility criteria
Inclusion criteria
\- Family member of ICU Recovery Clinic patient enrolled in parent BH CoCM study
Exclusion criteria
- Serious mental illness (e.g., schizophrenia, mania)
- Late-stage dementia or cognitive impairment
- Limited English proficiency
- No internet-enabled device
- Prisoners
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Medical University of South Carolina — Charleston
Identifiers
NCT: NCT07390786 · Pro00145594