NCT03513289

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 Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2018

Shorter than P25 for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2018

Completed
29 days until next milestone

Study Start

First participant enrolled

April 3, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 1, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2019

Completed
Last Updated

February 18, 2020

Status Verified

February 1, 2020

Enrollment Period

12 months

First QC Date

March 5, 2018

Last Update Submit

February 14, 2020

Conditions

Keywords

ICU deliriumpost-intensive care syndromecritical illness myopathy

Outcome Measures

Primary Outcomes (1)

  • Survivorship Experiences from Patients

    30-minute audio-taped, semi-structured interviews with patients informing on post-ICU care coordination

    18 months

Secondary Outcomes (2)

  • Survivorship Experiences from Caregivers

    18 months

  • Survivorship Experiences from Clinicians

    18 months

Study Arms (1)

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

Interventions

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

Patient, Carer, and Clinician Interviews

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients and caregivers who were identified by collaborative members, or self-identify, as having been through a THRIVE Program, patients and caregivers who did not participate in a THRIVE program, and 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.

You may qualify if:

  • 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.

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Australian and New Zealand Intensive Care Research Centre

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

postintensive care syndrome

Interventions

Caregivers

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • Carla M Sevin, M.D.

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine, Director of the ICU Recovery Center at Vanderbilt

Study Record Dates

First Submitted

March 5, 2018

First Posted

May 1, 2018

Study Start

April 3, 2018

Primary Completion

March 15, 2019

Study Completion

March 15, 2019

Last Updated

February 18, 2020

Record last verified: 2020-02

Locations