Clinical trial NCT02911896: Physical Function in Critical Care (PaciFIC)
Official title: Physical Function in Critical Care (PaciFIC): An Multi-centre Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intensive Care (ICU) Myopathy
Keywords: physical function
critical care
Lead sponsor: University of Melbourne
Sponsor class: OTHER
Collaborators: name: Melbourne Health
name: Flinders Medical Centre
name: National University Hospital, Singapore
name: Escola Superior da Saude, Brazil
First posted: 2016-09-22
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Multi-centre study conducted in four acute hospitals: Royal Melbourne Hospital, Melbourne, Australia; Flinders Medical Centre, Adelaide, Australia; Escola Superior da Saude, Brasilia, Brazil; and National University Hospital, Singapore.

Brief summary: Impairment in physical function is a significant problem for survivors of critical illness. There is a growing urgency to develop a core set of outcome measures, which can be adopted in clinical and research practice to evaluate efficacy in response to interventions such as rehabilitation.

Phase 1: Development of a new outcome measure. This study aims to examine the development of a single outcome measure which may be able to be utilised across the continuum of recovery of critical illness in the evaluation of physical function. The study will involve examination of two common physical function measures - the Physical Function in intensive care test scored (PFIT-s) and De Morton Mobility Index (DEMMI) and the development of a new measure based on rasch principles which may be able to capture physical functioning changes in individuals with critical illness. Aims: (1) To determine the clinical utility of two physical function measures (DEMMI and PFIT-s) when used in isolation across the hospital admission; and (2) To transform the (15-item) DEMMI and (4-item) PFIT-s into a single measure to evaluate function in intensive care survivors using Rasch analytical principles.

Phase 2: Measurement properties of the PACIFIC physical function outcome measure in an independent validation sample.

Detailed description: Consecutive eligible patients will be recruited into the study.

Phase 1: Two outcome measures - PFIT-s and DEMMI will be performed within 24 hour period. Order of testing will be randomised to minimise testing bias. Time-points of assessment are: awakening, ICU discharge and hospital discharge. Weekly measures will also be performed if required in ICU and/or ward settings for up to a maximum of 30 days in each setting. The measurement properties of the individual tools PFIT-s and DEMMI will be examined (e.g. validity, responsiveness).

Phase 2: Based on the findings in Phase 1 a new single outcome measure will be developed. In the second phase examination of the measurement properties of the tool will be undertaken including (reliability, validity, responsiveness).

Eligibility criteria: Inclusion Criteria:

* Adults \> 18 years of age
* Mechanically ventilated \> 48 hours
* Premorbid able to ambulate at least 10m independently prior to ICU admission (+/- gait aid)

Exclusion Criteria:

* Premorbid physical or cognitive impairment which would prevent ability to perform functional measures
* New neurological impairment such as stroke or spinal cord injury
* Trauma or orthopaedic injury requiring period of immobilization or non weight bearing status
* Traumatic brain injury with focal neurology

Primary outcomes:
measure: Change in Physical Function in Intensive Care Test scored (PFIT-s) and De Morton Mobility Index from ICU awakening to hospital discharge
timeFrame: Baseline to hospital discharge (up to 3 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: University of South Australia and Flinders Medical Centre
state: South Australia
city: Melbourne
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Brazil
country: Brazil
facility: Escola superior de ciências da saúde ESCS
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: University of Melbourne
name: Dr Selina M Parry, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parry SM, Granger CL, Berney S, Jones J, Beach L, El-Ansary D, Koopman R, Denehy L. Assessment of impairment and activity limitations in the critically ill: a systematic review of measurement instruments and their clinimetric properties. Intensive Care Med. 2015 May;41(5):744-62. doi: 10.1007/s00134-015-3672-x. Epub 2015 Feb 5.
citation: Parry SM, Denehy L, Beach LJ, Berney S, Williamson HC, Granger CL. Functional outcomes in ICU - what should we be using? - an observational study. Crit Care. 2015 Mar 29;19(1):127. doi: 10.1186/s13054-015-0829-5.