Post Intensive Care Unit SyndromeNCT05044221
Supporting the Recovery Needs of Patients Following Intensive Care
An observational study of Post Intensive Care Unit Syndrome and Post Intensive Care Syndrome, run by University of Melbourne at 2 sites in Australia.
Trial summary
Recovery for intensive care survivors is limited by ongoing problems with walking, strength, fatigue, mental distress and cognitive morbidity known as 'Post Intensive Care Syndrome'. There has been increasing interest in ways that clinicians can support patients in their post ICU recovery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Intensive Care Unit Syndrome, Post Intensive Care Syndrome, ICU Acquired Weakness
- What is being tested?
- Former ICU patient and caregiver workshops and Health care professional workshops
- How many people
- 40 participants
- Where
- 2 sitesAustralia
- Study dates
- 31 Aug 2021to Jul 2022
- 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: Participants will be recruited across two Australian hospitals
Who may be able to join
- Hospitalized adults, aged 18 years or over
- Admitted to the ICU requiring invasive mechanical ventilation for > 48 hours and remain in the ICU for a minimum of four days
- Living at home before the current admission (not in a facility and/or no fixed abode)
Who cannot join
- Non-English speaking (insufficient English language skills to read and understand questionnaires and patient information consent form)
- Pre-existing documented cognitive impairment
- Spinal cord injury or other primary neuromuscular disease
- New lower limb fracture with altered weight bearing status
- Expected survival < 3 months according to the treating medical team
- Active substance abuse or psychosis
Show all 12Show fewer
- Lack of access to telephone / computer or inability to use these resources independently (which would impact on ability to complete the intervention)
- Pregnancy
- Suicidality
- Incarcerated
- Cardiac surgery within this ICU admission (as these patients routinely receive a standard outpatient rehabilitation through cardiac rehabilitation)
- Poor premorbid mobility defined as < 10 metres ambulation +/- gait aid independently
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
The Royal Melbourne Hospital
Melbourne, Victoria, 3050
St Vincent's Hospital Melbourne
Melbourne, Victoria, 3065
About this study
Recovery for intensive care survivors is limited by ongoing problems with walking, strength, fatigue, mental distress and cognitive morbidity known as 'Post Intensive Care Syndrome'. There has been increasing interest in ways that clinicians can support patients in their post ICU recovery.
The investigators are undertaking a co design approach to informing the design of a recovery pathway for patients who have been admitted to the intensive care to support them in their return to home, family and working responsibilities.
Read the detailed description
This project will aim to involve ~ 20 past ICU patient/family members and ~20 health professionals to participate in a co-design approach to examine the recovery needs and resources that are required to support patients after leaving hospital. Using an experience based co design methodology three 2-hour workshops will be run with the first workshop involving patients/family members, the second involving healthcare professionals to separately gain thoughts and perspectives, and then the final workshop which will be combined to identify and problem solve priority resources and solutions.
- Conditions
- Post Intensive Care Unit Syndrome, Post Intensive Care Syndrome, ICU Acquired Weakness, Intensive Care Unit Syndrome, Intensive Care Unit Acquired Weakness
- Being tested
- Former ICU patient and caregiver workshops, Health care professional workshops
- 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.
Former ICU patient and caregiver workshopsOther
Also called In depth interviews and workshops
In depth interviews and workshops will be conducted with individuals enrolled in the study.
Health care professional workshopsOther
Also called In depth interviews and workshops
In depth interviews and workshops will be conducted with individuals enrolled in the study.
| Study group | Role | What they receive |
|---|---|---|
| Interviews: Past ICU patients and caregivers | Former ICU patients and their families that meet the following criteria: Adults > 18 years and above who required at least 48 hours of invasive mechanical ventilation and were in the ICU at least 4 days with an ICU admission in the past five years; and able to participate in a workshop in English. Receives: Other: Former ICU patient and caregiver workshops | |
| Interviews: Health care professionals | Active working health professionals with prior experience working directly in the ICU setting and/or care for ICU patients in their own clinical rea (acute, subacute and/or community settings). Receives: Other: Health care professional workshops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lived experiences and opinions
Capability Opportunity Motivation Barriers and Theoretical Domains Framework will be used to interpret qualitative data from the workshops and interviews.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start31 Aug 2021
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Intensive Care Unit SyndromeStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selina M Parry, University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05044221
- Sponsor's protocol ID
- 2020.333
- Other IDs
- RMH69389
- Status last verified
- Oct 2021
- First submitted
- 30 Aug 2021
- Last updated
- 21 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
da Silva AA, Granger CL, Abo S, Sheehan J, Barson E, Beach L, Pound G, Ali Abdelhamid Y, Fetterplace K, Fini NA, Merolli M, Sloan E, Parry SM. "How Do I Test the Waters? How Do I Go Forward?": Codesigning a Supportive Pathway after Critical Illness. Ann Am Thorac Soc. 2024 Jun;21(6):916-927. doi: 10.1513/AnnalsATS.202307-599OC.
PubMed 38330169
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting the Recovery Needs of Patients Following Intensive Care
- ClinicalTrials.gov ID
- NCT05044221
- Acronym / sponsor ID
- 2020.333
- Conditions
- Post Intensive Care Unit Syndrome, Post Intensive Care Syndrome, ICU Acquired Weakness, Intensive Care Unit Syndrome, Intensive Care Unit Acquired Weakness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 14 Sep 2021 (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.
Recovery for intensive care survivors is limited by ongoing problems with walking, strength, fatigue, mental distress and cognitive morbidity known as 'Post Intensive Care Syndrome'. There has been increasing interest in ways that clinicians can support patients in their post ICU recovery.
The investigators are undertaking a co design approach to informing the design of a recovery pathway for patients who have been admitted to the intensive care to support them in their return to home, family and working responsibilities.
Detailed description
This project will aim to involve ~ 20 past ICU patient/family members and ~20 health professionals to participate in a co-design approach to examine the recovery needs and resources that are required to support patients after leaving hospital. Using an experience based co design methodology three 2-hour workshops will be run with the first workshop involving patients/family members, the second involving healthcare professionals to separately gain thoughts and perspectives, and then the final workshop which will be combined to identify and problem solve priority resources and solutions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interviews: Past ICU patients and caregivers | – | Other: Former ICU patient and caregiver workshopsFormer ICU patients and their families that meet the following criteria: Adults > 18 years and above who required at least 48 hours of invasive mechanical ventilation and were in the ICU at least 4 days with an ICU admission in the past five years; and able to participate in a workshop in English. |
| Interviews: Health care professionals | – | Other: Health care professional workshopsActive working health professionals with prior experience working directly in the ICU setting and/or care for ICU patients in their own clinical rea (acute, subacute and/or community settings). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited across two Australian hospitals
Key inclusion criteria (3 listed)
- Hospitalized adults, aged 18 years or over
- Admitted to the ICU requiring invasive mechanical ventilation for > 48 hours and remain in the ICU for a minimum of four days
- Living at home before the current admission (not in a facility and/or no fixed abode)
Key exclusion criteria (12 listed)
- Non-English speaking (insufficient English language skills to read and understand questionnaires and patient information consent form)
- Pre-existing documented cognitive impairment
- Spinal cord injury or other primary neuromuscular disease
- New lower limb fracture with altered weight bearing status
- Expected survival < 3 months according to the treating medical team
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 |
|---|---|---|
| Former ICU patient and caregiver workshopsAlso: In depth interviews and workshopsIn depth interviews and workshops will be conducted with individuals enrolled in the study. | Other | Interviews: Past ICU patients and caregivers |
| Health care professional workshopsAlso: In depth interviews and workshopsIn depth interviews and workshops will be conducted with individuals enrolled in the study. | Other | Interviews: Health care professionals |
Primary outcome
Lived experiences and opinions
Time frame: 3 months
Capability Opportunity Motivation Barriers and Theoretical Domains Framework will be used to interpret qualitative data from the workshops and interviews.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
- Derived from this study: PubMed 38330169da Silva AA, Granger CL, Abo S, Sheehan J, Barson E, Beach L, Pound G, Ali Abdelhamid Y, Fetterplace K, Fini NA, Merolli M, Sloan E, Parry SM. "How Do I Test the Waters? How Do I Go Forward?": Codesigning a Supportive Pathway after Critical Illness. Ann Am Thorac Soc. 2024 Jun;21(6):916-927. doi: 10.1513/AnnalsATS.202307-599OC.
- Individual participant dataSharing planned: No
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Post ICU Syndrome
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Intensive Care Unit Syndrome and Post Intensive Care Syndrome, run by University of Melbourne at 2 sites in Australia.
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 12 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: status not confirmed, as of the sponsor's last update on 21 Oct 2021. 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 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?
Results are not available in the source record.
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?
Lived experiences and opinions (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05044221, which also lists 1 linked publication.
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 21 Oct 2021.