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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03513289
Ethics application status
Date submitted
5/03/2018
Date registered
1/05/2018

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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03513289