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Supporting the Recovery Needs of Patients Following Intensive Care

Sponsor
University of Melbourne (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05044221
Collaborator
(none)
40
Enrollment
2
Locations
10
Anticipated Duration (Months)
20
Patients Per Site
2
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Supporting the Recovery Needs of Patients Following Intensive Care
Actual Study Start Date :
Aug 31, 2021
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

Arm 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 Names:
  • 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 Names:
  • In depth interviews and workshops

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Lived experiences and opinions [3 months]

      Capability Opportunity Motivation Barriers and Theoretical Domains Framework will be used to interpret qualitative data from the workshops and interviews.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Royal Melbourne Hospital Melbourne Victoria Australia 3050
    2 St Vincent's Hospital Melbourne Melbourne Victoria Australia 3065

    Sponsors and Collaborators

    • University of Melbourne

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Selina M Parry, Cardiorespiratory Team Lead, Department of Physiotherapy, University of Melbourne
    ClinicalTrials.gov Identifier:
    NCT05044221
    Other Study ID Numbers:
    • 2020.333
    • RMH69389
    First Posted:
    Sep 14, 2021
    Last Update Posted:
    Oct 21, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Syndrome
    Asthenia

    Study Results

    No Results Posted as of Oct 21, 2021