CAIRN: Collaborative Assessment of ICU Recovery Needs

Sponsor

Vanderbilt University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT03513289

Collaborator

Society of Critical Care Medicine (Other)

Enrollment

Locations

11.4

Actual Duration (Months)

Patients Per Site

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post-Intensive Care Syndrome	Other: Patient, Carer, and Clinician Interviews

Detailed Description

The aims of this qualitative study are:

To identify elements that helped survivors in their recovery, as well as potential obstacles
To capture elements of survivorshop that are generalizable, regardless of participation in the THRIVE collaboratives
To gain knowledge to be incorporated back into the collaboratives

Patients, family members, and clinicians will be interviewed and their responses analyzed for themes of ICU recovery including elements that patients and families find helpful to recovery, barriers and facilitators to different models of post-ICU support, including peer support and post-ICU clinics, and drivers of improvement in post-ICU care. Patients, carers, and clinicians with a wide variety of survivorship experiences are encouraged to participate, including those who have participated in a THRIVE collaborative support site (peer support or clinic).

Study Design

Study Type:

Observational

Actual Enrollment :

66 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Collaborative Assessment of ICU Recovery Needs

Actual Study Start Date :

Apr 3, 2018

Actual Primary Completion Date :

Mar 15, 2019

Actual Study Completion Date :

Mar 15, 2019

Arms and Interventions

Arm	Intervention/Treatment
Patient, Carer, and Clinician Interviews This group/cohort consists of patients who experienced critical illness and were hospitalized in an ICU setting.	Other: Patient, Carer, and Clinician Interviews Post-ICU follow-up interviews conducted over the phone, lasting between 30-60 minutes.

Arm

Intervention/Treatment

Patient, Carer, and Clinician Interviews

This group/cohort consists of patients who experienced critical illness and were hospitalized in an ICU setting.

Other: Patient, Carer, and Clinician Interviews

Post-ICU follow-up interviews conducted over the phone, lasting between 30-60 minutes.

Outcome Measures

Primary Outcome Measures

Survivorship Experiences from Patients [18 months]
30-minute audio-taped, semi-structured interviews with patients informing on post-ICU care coordination

Secondary Outcome Measures

Survivorship Experiences from Caregivers [18 months]
30-minute audio-taped, semi-structured interviews with caregivers informing on post-ICU care coordination
Survivorship Experiences from Clinicians [18 months]
30-minute audio-taped, semi-structured interviews with clinicians informing on post-ICU care coordination

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
2	Australian and New Zealand Intensive Care Research Centre	Melbourne	Victoria	Australia	3004

Sponsors and Collaborators

Vanderbilt University Medical Center
Society of Critical Care Medicine

Investigators

Principal Investigator: Carla M Sevin, M.D., Vanderbilt University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Carla Sevin, Assistant Professor of Medicine, Director of the ICU Recovery Center at Vanderbilt, Vanderbilt University Medical Center

ClinicalTrials.gov Identifier:

NCT03513289

Other Study ID Numbers:

172158

First Posted:

May 1, 2018

Last Update Posted:

Feb 18, 2020

Last Verified:

Feb 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Carla Sevin, Assistant Professor of Medicine, Director of the ICU Recovery Center at Vanderbilt, Vanderbilt University Medical Center

ICU delirium

post-intensive care syndrome

critical illness myopathy

Additional relevant MeSH terms:

Syndrome

Study Results

No Results Posted as of Feb 18, 2020