Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000539235
Ethics application status
Approved
Date submitted
28/03/2018
Date registered
11/04/2018
Date last updated
11/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does very early therapy reduce the time spent hospital and improve the recovery of people with serious illness?
Scientific title
Does very early inreach hospital rehabilitation for people with critical illness reduce hospital length of stay and improve functional outcomes? A pilot randomised control trial.
Secondary ID [1] 294362 0
Nil known
Universal Trial Number (UTN)
Trial acronym
VERICI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical illness 307089 0
Condition category
Condition code
Physical Medicine / Rehabilitation 306201 306201 0 0
Occupational therapy
Physical Medicine / Rehabilitation 306202 306202 0 0
Physiotherapy
Physical Medicine / Rehabilitation 306221 306221 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group received additional interventions from an in-reach mobile rehabilitation team, with the aim of delivering higher intensity rehabilitation. This team consisted of a rehabilitation physician (0.2 FTE), a nurse (0.2 FTE), a fulltime physiotherapist and occupational therapist. Participants in the intervention group were all visited by the rehabilitation physician for an initial assessment. Subsequent visits were based on clinical needs, typically once or twice per week. A structured multidisciplinary rehabilitation program was devised for each patient. This aimed to address individual patient needs, involved the patient in decision-making, goal setting and was regularly reviewed during the patient journey via weekly multidisciplinary team meetings (case conferencing). The in-reach therapists worked with ward therapists so the therapy intensity delivered was over and above what the patient would normally receive from ward therapists. Up to 2 sessions of therapy of 30 minutes duration were provided.

The mobile rehabilitation team had a case load of 6-8 patients at any one time. This team commenced rehabilitation immediately after baseline assessment, soon after ICU discharge to the general ward. The team was available 5 days per week, and rehabilitation interventions were chosen by the therapists according to patient needs. The duration of the study intervention was also determined by clinical need i.e. patients could be discharged from the service once all rehabilitation goals were achieved. For those needing inpatient rehabilitation, the in-reach team remained involved until acute hospital discharge and transfer to rehabilitation.
Intervention code [1] 300667 0
Rehabilitation
Comparator / control treatment
The usual care group, therapy could be provided by usual therapists in the ICU or acute ward. A rehabilitation physician was still able to review the patient at the request of the treating team and the MRT may have been involved if deemed necessary.
Control group
Active

Outcomes
Primary outcome [1] 305209 0
Acute hospital length of stay (days) collected from the patient medical record
Timepoint [1] 305209 0
On discharge from acute hospital
Primary outcome [2] 305210 0
Inpatient rehabilitation length of stay (if provided in days) collected from the patient medical record
Timepoint [2] 305210 0
On discharge from inpatient rehabilitation
Secondary outcome [1] 344509 0
Muscle strength measured using the ICU acquired weakness scale
Timepoint [1] 344509 0
Measured at baseline and on discharge from acute hospital
Secondary outcome [2] 344510 0
Functional independence measured by the Functional Independence Measure
Timepoint [2] 344510 0
Measured at baseline and on discharge from acute hospital
Secondary outcome [3] 344511 0
Mobility measured using Timed-Up and Go Test
Timepoint [3] 344511 0
Measured on discharge from acute hospital
Secondary outcome [4] 344512 0
Mobility/endurance both measured using the 6 minute walk test (composite measure)
Timepoint [4] 344512 0
Measured on discharge from acute hospital
Secondary outcome [5] 344513 0
Symptoms of depression, anxiety and stress all measured using Depression and Anxiety Stress Scale (DASS-21)(composite measure)
Timepoint [5] 344513 0
Measured on discharge from acute hospital, at 6 month follow up and 12 month follow up
Secondary outcome [6] 344514 0
Discharge destination
Timepoint [6] 344514 0
Measured on discharge from acute hospital and inpatient rehabilitation
Secondary outcome [7] 344515 0
Ability to complete instrumental activities of daily living measured using Lawton’s Activities of Daily Living Assessment
Timepoint [7] 344515 0
Measured at baseline (assessing premorbid ability, at 6 month follow up and 12 month follow up
Secondary outcome [8] 344516 0
Quality of life measured using Short Form-12 (SF-12 v2) and the Assessment Quality of Life (AQoL-4D) questionnaire (single outcome assessed using two outcome measures)
Timepoint [8] 344516 0
Measured at 6 month follow up and 12 month follow up

Eligibility
Key inclusion criteria
• Inpatients with an ICU length of stay of 5 or more days.
• Baseline functional independence (defined a priori as a Barthel Index score of 70 or higher obtained from a proxy describing patient function 2 weeks before admission) (those who are functionally dependent prior to critical illness may have limited rehabilitation potential)
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Adult patients receiving palliative care or not expected to survive (withdrawing life support and considering comfort measures only)
• Irreversible disorders with 6-month mortality estimated at more than 50%
• Unable to be followed up e.g. travellers, rural residents, homeless, deaf
• Unable to speak English (many of the instruments used do not have translations)
• Pre-existing diagnosis of dementia of any aetiology (those who are cognitively impaired may have limited rehabilitation potential)
• Severe psychiatric disorders with recent hospitalisation (within 6 months) or an active substance abuse (they may have limited rehabilitation potential)
• Living in residential care at baseline (those who are functionally dependent prior to critical illness may have limited rehabilitation potential)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Group allocation was arranged in sealed envelopes prepared by an administrative staff member with no role in clinical care or the study procedures.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation was performed using a web-based, computer-generated randomisation procedure (accessed from http://www.graphpad.com/quickcalcs/randomize1.cfm 12/11/2012).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Groups were compared at baseline, at hospital discharge and at follow-up using independent t test for normally distributed continuous data and Mann-Whitney U test for non-normally distributed data and chi squared test for categorical variables. Analysis of outcome data was by intention to treat. Longitudinal changes in continuous data (e.g. FIM, DASS-21) were analysed using a repeated measures ANOVA, focussing on group differences over time. SPSS v21 (IBM Corp., Armonk, NY, USA) was used to perform the analyses.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
11/05/2015
Date of last participant enrolment
Anticipated
Actual
29/08/2016
Date of last data collection
Anticipated
Actual
13/10/2017
Sample size
Target
80
Accrual to date
Final
66
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 10406 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 22091 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 299005 0
Government body
Name [1] 299005 0
Agency for Clinical Innovation
Country [1] 299005 0
Australia
Funding source category [2] 299010 0
Charities/Societies/Foundations
Name [2] 299010 0
Australasian Faculty of Rehabilitation Medicine
Country [2] 299010 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital
Address
C/o Department of Rehabilitation
Sacred Heart Rehabilitation
St Vincent's Hospital
170 Darlinghurst Rd
Darlinghurst, NSW 2010
Country
Australia
Secondary sponsor category [1] 298230 0
None
Name [1] 298230 0
Address [1] 298230 0
Country [1] 298230 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299932 0
St Vincent's Hospital HREC
Ethics committee address [1] 299932 0
St Vincent's
390 Victoria Street,
Darlinghurst, New South Wales 2010
Ethics committee country [1] 299932 0
Australia
Date submitted for ethics approval [1] 299932 0
22/11/2012
Approval date [1] 299932 0
25/01/2013
Ethics approval number [1] 299932 0
HREC/12/SVH/324

Summary
Brief summary
The aim of the study was to determine whether early, structured rehabilitation is effective in critically ill patients in aiding physical and psychological recovery. The study was conducted as a trial and compared patients receiving early rehabilitation versus usual care. Patients were assessed on commencement on the study, on discharge from hospital, and at 6 and 12 months. The study was conducted at St. Vincent’s Hospital Sydney. Patients were eligible for the study if they were critically ill patients and were in intensive care (ICU) for at least 5 days.

The early rehabilitation group received early routine screening by a rehabilitation physician, routine multidisciplinary assessment and provision of individualised, structured rehabilitation programme (up to two 30-minute therapy sessions per day) with formal coordination through case conferencing. This was be provided through the Mobile Rehabilitation Team (MRT). The participants were followed-up by the rehabilitation clinic The key components were daily team communication, higher intensity of therapy than usual care, and weekly case conferencing.

In the usual care group, therapy could be provided by usual therapists in the ICU or acute ward. A rehabilitation physician was still able to review the patient at the request of the treating team and the MRT may have been involved if deemed necessary.

The 2 groups were followed at hospital discharge and at 6 and 12 months. Outcomes assessed at discharge included their length of hospital day; muscle strength; mobility/endurance; functional independence/ability to carry out activities of daily living; and symptoms of depression, anxiety and stress. The outcomes assessed at 6 and 12 months included: ability to carry out activities of daily living; symptoms of depression, anxiety and stress; and quality of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82030 0
A/Prof Steven Faux
Address 82030 0
Department of Rehabilitation
Sacred Heart Rehabilitation
St Vincent's Hospital
170 Darlinghurst Rd
Darlinghurst, NSW 2010
Country 82030 0
Australia
Phone 82030 0
+61283829516
Fax 82030 0
Email 82030 0
sfaux@stvincents.com.au
Contact person for public queries
Name 82031 0
Jane Wu
Address 82031 0
Department of Rehabilitation
Sacred Heart Rehabilitation
St Vincent's Hospital
170 Darlinghurst Rd
Darlinghurst, NSW 2010
Country 82031 0
Australia
Phone 82031 0
+61283829516
Fax 82031 0
Email 82031 0
Jane.Wu@svha.org.au
Contact person for scientific queries
Name 82032 0
Jane Wu
Address 82032 0
Department of Rehabilitation
Sacred Heart Rehabilitation
St Vincent's Hospital
170 Darlinghurst Rd
Darlinghurst, NSW 2010
Country 82032 0
Australia
Phone 82032 0
+61283829516
Fax 82032 0
Email 82032 0
Jane.Wu@svha.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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