Post-Intensive Care SyndromeCAIRNNCT03513289
Collaborative Assessment of ICU Recovery Needs
An observational study of Post-Intensive Care Syndrome, run by Vanderbilt University Medical Center at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Intensive Care Syndrome
- What is being tested?
- Patient, Carer, and Clinician Interviews
- How many people
- 66 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 3 Apr 2018to 15 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- N/A
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Australia1 site
Australian and New Zealand Intensive Care Research Centre
Melbourne, Victoria, 3004
About this study
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.
Read the 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).
- Conditions
- Post-Intensive Care Syndrome
- Being tested
- Patient, Carer, and Clinician Interviews
- Keywords
- ICU delirium, post-intensive care syndrome, critical illness myopathy
- Medical subject headings
- postintensive care syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient, Carer, and Clinician InterviewsOther
Post-ICU follow-up interviews conducted over the phone, lasting between 30-60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Patient, Carer, and Clinician Interviews | This group/cohort consists of patients who experienced critical illness and were hospitalized in an ICU setting. Receives: Other: Patient, Carer, and Clinician Interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survivorship Experiences from Patients
30-minute audio-taped, semi-structured interviews with patients informing on post-ICU care coordination
Measured: 18 months
Secondary outcomes (2)
Survivorship Experiences from Caregivers
30-minute audio-taped, semi-structured interviews with caregivers informing on post-ICU care coordination
Measured: 18 months
Survivorship Experiences from Clinicians
30-minute audio-taped, semi-structured interviews with clinicians informing on post-ICU care coordination
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study start3 Apr 2018
- Primary completion15 Mar 2019
- Study completion15 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Intensive Care SyndromeStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Critical Care Medicine
- Responsible party
- Principal investigator, Carla Sevin, Vanderbilt University Medical Center
- Investigators
- Carla M Sevin, M.D., Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03513289
- Sponsor's protocol ID
- 172158
- Acronym
- CAIRN
- Status last verified
- Feb 2020
- First submitted
- 5 Mar 2018
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Assessment of ICU Recovery Needs
- ClinicalTrials.gov ID
- NCT03513289
- Acronym / sponsor ID
- CAIRN / 172158
- Conditions
- Post-Intensive Care Syndrome
- Keywords
- ICU delirium, post-intensive care syndrome, critical illness myopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Society of Critical Care Medicine
- Study start
- 3 Apr 2018 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 1 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient, Carer, and Clinician Interviews | – | Other: Patient, Carer, and Clinician InterviewsThis group/cohort consists of patients who experienced critical illness and were hospitalized in an ICU setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient, Carer, and Clinician InterviewsPost-ICU follow-up interviews conducted over the phone, lasting between 30-60 minutes. | Other | Patient, Carer, and Clinician Interviews |
Primary outcome
Survivorship Experiences from Patients
Time frame: 18 months
30-minute audio-taped, semi-structured interviews with patients informing on post-ICU care coordination
2 secondary outcomes
Survivorship Experiences from Caregivers
Time frame: 18 months
Survivorship Experiences from Clinicians
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carla M Sevin, M.D. principal investigator
Vanderbilt University Medical Center
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Intensive Care Syndrome, run by Vanderbilt University Medical Center at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survivorship Experiences from Patients (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2020.