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Supporting the Recovery Needs of Patients Following Intensive Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT05044221
Recruitment Status : Enrolling by invitation
First Posted : September 14, 2021
Last Update Posted : October 21, 2021
Information provided by (Responsible Party):
Selina M Parry, University of Melbourne

Brief 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.

Condition or disease Intervention/treatment
Post Intensive Care Unit Syndrome Post Intensive Care Syndrome ICU Acquired Weakness Intensive Care Unit Syndrome Intensive Care Unit Acquired Weakness Other: Former ICU patient and caregiver workshops Other: Health care professional workshops

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.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Supporting the Recovery Needs of Patients Following Intensive Care
Actual Study Start Date : August 31, 2021
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Group/Cohort Intervention/treatment
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.
Other: Former ICU patient and caregiver workshops
In depth interviews and workshops will be conducted with individuals enrolled in the study.
Other Name: In depth interviews and 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).
Other: Health care professional workshops
In depth interviews and workshops will be conducted with individuals enrolled in the study.
Other Name: In depth interviews and workshops

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants will be recruited across two Australian hospitals

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05044221

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Australia, Victoria
The Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050
St Vincent's Hospital Melbourne
Melbourne, Victoria, Australia, 3065
Sponsors and Collaborators
University of Melbourne
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Responsible Party: Selina M Parry, Cardiorespiratory Team Lead, Department of Physiotherapy, University of Melbourne Identifier: NCT05044221    
Other Study ID Numbers: 2020.333
RMH69389 ( Other Identifier: ERM )
First Posted: September 14, 2021    Key Record Dates
Last Update Posted: October 21, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pathologic Processes