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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03513289




Registration number
NCT03513289
Ethics application status
Date submitted
5/03/2018
Date registered
1/05/2018
Date last updated
18/02/2020

Titles & IDs
Public title
Collaborative Assessment of ICU Recovery Needs
Scientific title
Collaborative Assessment of ICU Recovery Needs
Secondary ID [1] 0 0
172158
Universal Trial Number (UTN)
Trial acronym
CAIRN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-Intensive Care Syndrome 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Patient, Carer, and Clinician Interviews

Patient, Carer, and Clinician Interviews - This group/cohort consists of patients who experienced critical illness and were hospitalized in an ICU setting.


Other interventions: Patient, Carer, and Clinician Interviews
Post-ICU follow-up interviews conducted over the phone, lasting between 30-60 minutes.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Survivorship Experiences from Patients
Timepoint [1] 0 0
18 months
Secondary outcome [1] 0 0
Survivorship Experiences from Caregivers
Timepoint [1] 0 0
18 months
Secondary outcome [2] 0 0
Survivorship Experiences from Clinicians
Timepoint [2] 0 0
18 months

Eligibility
Key inclusion criteria
1. Patients who survived a critical illness, and their carers, who were identified by
collaborative members or self-identify as having been through a THRIVE Program.

2. Patients who survived a critical illness, and their carers, who did not participate in
a THRIVE program.

3. Clinicians directly involved in the care of ICU survivors in the outpatient setting,
who have participated in a THRIVE initiative through the Society of Critical Care
Medicine.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- N/A

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/04/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/03/2019
Sample size
Target
Accrual to date
Final
66
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Australian and New Zealand Intensive Care Research Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Tennessee

Funding & Sponsors
Primary sponsor type
Other
Name
Vanderbilt University Medical Center
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Society of Critical Care Medicine
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The primary purpose of this study is to better understand the impact of the Society of
Critical Care Medicine (SCCM) THRIVE Collaboratives on patients, their families and
clinicians.

The investigators have formed an international and interprofessional evaluative team with
experts in the field in an effort to explore interactions between survivors and THRIVE. This
approach is reflective of the international ethos of SCCM and its collaboratives, with the
potential to improve the generalizability of this survivorship research to different health
systems.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03513289
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Carla M Sevin, M.D.
Address 0 0
Vanderbilt University Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries