Supporting the Recovery Needs of Patients Following Intensive Care

Intensive Care Unit Syndrome Clinical Trial

Official title:

Supporting the Recovery Needs of Patients Following Intensive Care

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05044221
• Other study ID #: 2020.333
• Secondary ID: RMH69389
• Status: Enrolling by invitation
• Start date: August 31, 2021
• Est. completion date: July 2022

Study information

• Verified date: October 2021
• Source: University of Melbourne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: July 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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
• 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

Related Conditions & MeSH terms

• ICU Acquired Weakness
• Intensive Care Unit Acquired Weakness
• Intensive Care Unit Syndrome
• Post Intensive Care Syndrome
• Post Intensive Care Unit Syndrome
• Syndrome

Intervention

Other:
• Former ICU patient and caregiver workshops
In depth interviews and workshops will be conducted with individuals enrolled in the study.
• Health care professional workshops
In depth interviews and workshops will be conducted with individuals enrolled in the study.

Locations

Country	Name	City	State
Australia	St Vincent's Hospital Melbourne	Melbourne	Victoria
Australia	The Royal Melbourne Hospital	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
University of Melbourne

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lived experiences and opinions	Capability Opportunity Motivation Barriers and Theoretical Domains Framework will be used to interpret qualitative data from the workshops and interviews.	3 months