Physical Function in Critical Care (PaciFIC) (PaciFIC)

Physical Function in Critical Care (PaciFIC): An Multi-centre Observational Study

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.

Study Overview

• Status: Completed
• Conditions: Intensive Care (ICU) Myopathy

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).

• Study Type: Observational
• Enrollment (Actual): 151

Contacts and Locations

Study Locations

• Australia
  • South Australia
    • Adelaide, South Australia, Australia
      • University of South Australia and Flinders Medical Centre
  • Victoria
    • Melbourne, Victoria, Australia
      • Royal Melbourne Hospital
• Brazil
  • Brazil, Brazil
    • Escola superior de ciências da saúde ESCS
• Singapore
  • Singapore, Singapore
    • National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Physical Function in Intensive Care Test scored (PFIT-s) and De Morton Mobility Index from ICU awakening to hospital discharge	Both measures are primary - there will be a single measure developed as composite in line with aims of this observational study	Baseline to hospital discharge (up to 3 months)

Collaborators and Investigators

• Sponsor: University of Melbourne
• Collaborators: Melbourne Health; National University Hospital, Singapore; Flinders Medical Centre; Escola Superior da Saude, Brazil
• Investigators: Principal Investigator: Dr Selina M Parry, PhD, University of Melbourne

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: July 25, 2016
• First Submitted That Met QC Criteria: September 21, 2016
• First Posted (Estimate): September 22, 2016

Study Record Updates

• Last Update Posted (Actual): October 30, 2017
• Last Update Submitted That Met QC Criteria: October 26, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: critical care; physical function
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Muscular Diseases
• Other Study ID Numbers: 2015026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided