Clinical trial NCT03925181: A Recovery-Oriented Counselling Group
Official title: A Recovery-Oriented Counselling Group: Supporting Physical, Emotional, and Social Recovery Processes of Critical Care Patients in the ICU Recovery Clinic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Intensive Care Recovery
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Alberta Health services
First posted: 2019-04-24
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: In total, 12 ICU survivors will be recruited along with their 12 caregivers. Once participants have been recruited, they (and their caregivers) will be randomly assigned to 2 arms: intervention or no intervention (waitlist control). The waitlist control group will receive the intervention in the second arm after the first intervention arm is complete.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate a recovery-oriented group counselling program for post-discharged critical illness survivors and their caregivers.

Detailed description: The purpose of this pilot project is to develop and evaluate a recovery-oriented counselling group to support the physical, emotional, and social recovery processes of critical care survivors who access the services of the Calgary ICU Recovery Clinics. Upon discharge, critical care survivors are faced with challenges related to their stay in the Intensive Care Unit (ICU), as well as long-term recovery from critical illness. These challenges impact survivors' physical, emotional, social recovery processes, which reduce quality of life, delay (re)integration into their communities, and cause further health problems. Social support and counselling groups show therapeutic promise in supporting recovery processes by increasing social connection, quality of life, acquisition of skills, and emotional and psychological wellbeing.

The purpose of this study is to evaluate a recovery-oriented group counselling program for post-discharged critical illness survivors and their caregivers. The investigators will utilize Substance Abuse and Mental Health Service Administration's (SAMHSA) evidence-based recovery curriculum to develop a counsellor-facilitated recovery-oriented group for patients and caregivers focusing on peer support, relationships, evidence-based strategies, daily life, purpose and meaning-making, strengths, and resilience.

The research objectives are:

* Implement a recovery-oriented counselling group for ICU Recovery Clinic patients and their caregivers.
* Evaluate the recovery-oriented counselling group as situated within the Calgary ICU Recovery Clinic.

The investigators will utilize a Randomized Controlled Trial (RCT) design (non-clinical trial). Participants will be randomized into a treatment (intervention) or wait-list control group. Participants in the wait-list control group will be offered the intervention after the treatment group has completed the intervention group. The investigators will evaluate the intervention through the use of outcomes measures currently used by the ICU Recovery Clinic in a pre-test (t0), immediate post-test (t1), 3-month (t2), and 6-month (t3) follow-ups. In addition, the investigators will conduct a process evaluation of the intervention via content analysis of audio recorded data from semi-structured interviews and focus groups with participants. Patients and caregivers will participate in separate focus groups.

Eligibility criteria: Inclusion Criteria for Patients:

* Spent more than 4 days in the ICU,
* Were discharged into the community within 4 months of transfer out of the ICU (excluding patients who were in hospital long-term)
* Speaks English
* Has a fixed address
* Does not have pre-existing psychiatric diagnoses documented in the ICU transfer summary
* Lives within or surrounding Calgary.

Inclusion Criteria for Caregivers:

* Caregiver of an ICU survivor participant meeting criteria above
* Speaks English
* Has a fixed address
* Lives within or surrounding Calgary.

Exclusion Criteria for Patients:

- Long-term hospital stay

Excluding Criteria for Caregivers:

- None

Primary outcomes:
measure: Impact of Events Scale - Revised (IES-r)
timeFrame: Pre-test, immediately following 6-week group completion, 3-month, and 6-month.
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Pre-test, immediately following 6-week group completion, 3-month, and 6-month.
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: Pre-test, immediately following 6-week group completion, 3-month, and 6-month.
measure: Godin Leisure Time Activity Questionnaire
timeFrame: Pre-test, immediately following 6-week group completion, 3-month, and 6-month.
measure: Euroqol 5 Dimensions (EQ-5D-5L)
timeFrame: Pre-test, immediately following 6-week group completion, 3-month, and 6-month.
measure: Employment questionnaire
timeFrame: Pre-test, immediately following 6-week group completion, 3-month, and 6-month.
Secondary outcomes:
measure: Focus Group
timeFrame: Immediately following 6-week group completion
measure: Qualitative Survey
timeFrame: Immediately following 6-week group completion
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Calgary ICU Recovery Clinic: Foothills Medical Centre
state: Alberta
Study officials:
affiliation: University of Calgary
name: Tanya Mudry, PhD
role: PRINCIPAL_INVESTIGATOR
References: