Supporting the Recovery Needs of Patients Following Intensive Care

October 19, 2021 updated by: Selina M Parry, University of Melbourne

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.

Study Overview

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 Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Victoria
      • Melbourne, Victoria, Australia, 3050
        • The Royal Melbourne Hospital
      • Melbourne, Victoria, Australia, 3065
        • St Vincent's Hospital Melbourne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants will be recruited across two Australian hospitals

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.
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).
In depth interviews and workshops will be conducted with individuals enrolled in the study.
Other Names:
  • In depth interviews and workshops

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 31, 2021

Primary Completion (ANTICIPATED)

July 1, 2022

Study Completion (ANTICIPATED)

July 1, 2022

Study Registration Dates

First Submitted

August 30, 2021

First Submitted That Met QC Criteria

September 3, 2021

First Posted (ACTUAL)

September 14, 2021

Study Record Updates

Last Update Posted (ACTUAL)

October 21, 2021

Last Update Submitted That Met QC Criteria

October 19, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020.333
  • RMH69389 (OTHER: ERM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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