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Trial registered on ANZCTR


Trial ID
ACTRN12615000879561
Ethics application status
Approved
Date submitted
10/08/2015
Date registered
21/08/2015
Date last updated
15/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
CHERISH Collaborative for Hospitalised Elders: Reducing the Impact of Stays in Hospital
Scientific title
Do older hospital inpatients admitted to acute care wards implementing the "Eat Walk Engage" quality improvement programme have reduced geriatric syndromes, shorter length of stay and greater likelihood of discharge home than older inpatients admitted to control wards?
Secondary ID [1] 286584 0
Nil
Universal Trial Number (UTN)
U1111-1169-4943
Trial acronym
CHERISH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
delirium 294847 0
functional decline 294848 0
malnutrition 294849 0
Condition category
Condition code
Public Health 295114 295114 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
"Eat Walk Engage" is a quality improvement programme designed to enhance uptake of evidence-based processes of care for older inpatients. The target processes are early mobility; adequate oral nutritional intake; and meaningful, cognitively stimulating activities. The programme uses enabling facilitation based on the i-PARIHS implementation framework, and engages members of the multidisciplinary team on intervention wards to identify barriers to these processes, trial solutions, and embed successful solutions into practice. Solutions may entail both individual behaviour change and system redesign, and are individualised to the context. The facilitator supports change using methods such as marketing, team building, active reflection, process mapping, audit and feedback and education.
The facilitator is recruited within the study hospital, but resourced, trained and supported by the project team which includes expert facilitators. This includes a 3 day formal training course; fortnightly in-person or telephone support by the expert facilitator team; 6 monthly forum for sharing skills and experiences between sites; and ad hoc telephone support as required. Facilitator contacts will be monitored by the project manager to measure fidelity. The intervention will take place over 12 months. Facilitator roles include monthly 1-hour group meetings between the site facilitator and the ward multidisciplinary team; identification of local barriers and enablers; facilitation of the planning and implementation of small scale improvement cycles as agreed by the team to support the programme aims; identification of delegation tasks suitable for an additional part time health care assistant resourced by the project; audit and feedback of structured process measures related to the improvement aims (patient interviews, activity audits and mealtime audits); and escalation of barriers and solutions if necessary to higher level decision makers. Meeting minutes and field notes by the novice and expert facilitators will be used to monitor intervention fidelity, and 6 monthly structured process audits will measure implementation effectiveness.
Intervention code [1] 291700 0
Prevention
Comparator / control treatment
Usual ward care, including any facility based improvement programmes
Control group
Active

Outcomes
Primary outcome [1] 294880 0
length of hospital stay: number of days between inpatient admission and discharge from hospital based on hospital record
Timepoint [1] 294880 0
at discharge from hospital
Primary outcome [2] 294881 0
any geriatric syndrome (composite of delirium, functional decline, in-hospital falls, in-hospital pressure injury and new incontinence) based on participant assessment at admission, day 5 and discharge (basic activities of daily living scale, short portable mental status questionnaire, 3D-CAM delirium assessment tool, and recall of incontinence, falls and skin injuries); as well as review of clinical documentation in hospital record
Timepoint [2] 294881 0
at admission, day 5 and at discharge
Secondary outcome [1] 314273 0
death or discharge to higher level of care based on hospital record
Timepoint [1] 314273 0
at hospital discharge
Secondary outcome [2] 314274 0
delirium (3D-CAM and chart review)
Timepoint [2] 314274 0
by day 5 of admission and by discharge
Secondary outcome [3] 314275 0
functional decline (any increase in basic activities of daily living assistance compared to baseline) by patient (or proxy) self-report
Timepoint [3] 314275 0
by day 5, discharge, and 30 days after discharge
Secondary outcome [4] 314276 0
hospital readmission based on state-wide hospital admissions information system
Timepoint [4] 314276 0
within 30 days of discharge
Secondary outcome [5] 314277 0
mortality based on hospital records and telephone follow-up
Timepoint [5] 314277 0
in hospital or within 30 days of discharge
Secondary outcome [6] 314278 0
cost-utility analysis based on EQ5D and hospital costing database
Timepoint [6] 314278 0
30 days after discharge
Secondary outcome [7] 341998 0
Mortality based on statewide death registry data
Timepoint [7] 341998 0
6 months after hospital admission
Secondary outcome [8] 341999 0
Hospital readmissions from state-wide hospital admissions registry
Timepoint [8] 341999 0
6 months from discharge

Eligibility
Key inclusion criteria
Admitted to hospital for 3 or more days, with admission to nominated intervention or control ward
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Discharged from hospital within 2 days; palliative intent of care

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
As this is a system-level improvement intervention, the study is a cluster randomised controlled trial, comparing changes measured before and after intervention on 4 randomly selected intervention wards with the changes occurring over the same time period in 4 hospital-matched control wards. Randomisation occurs at the level of ward (each hospital providing a control and intervention ward) and will be undertaken by the off-site study statistician using a random number generator i.e. allocation is concealed. Participant allocation to each ward (and therefore to treatment or control) will occur based on usual hospital processes (diagnosis, treating team on call schedules, and bed availability).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generation by off-site study statistician
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Detailed process of care measure will supplement the outcome measures to help determine the effectiveness of the implementation process at each site
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Outcomes will be measured and analysed at a patient level, allowing for clustering by ward. Patient, ward and group characteristics will be described using summary statistics. Change in average length of stay between baseline (pre-intervention) and post-intervention will be compared between the intervention and control group using time-to-event analysis. Competing outcomes will be included to explore the impact on acute length of stay and discharge destination from acute stay (death/home/subacute or residential care). Participants who are still in-hospital at the end of study will be censored. The primary outcomes will be presented as: i) the average difference in length of stay, ii) the percentage change in geriatric syndromes. Outcomes will be presented as means or proportions and 95% confidence intervals. Plots of the cumulative risks of discharge by length of hospital stay will be compared between groups to examine the differences between groups in detail and to show whether the intervention effect varies by time in hospital.
The estimated sample size will provide 90% power to detect a difference of 10% in acute length of stay and discharge home and 20% reduction in geriatric syndromes. Proportions of participants developing secondary outcomes will be compared between groups using chi-squared testing. Modelling approaches (such as multiple logistic regression) will be used if needed to adjust for intergroup baseline differences, however we anticipate that the randomised design will protect against any confounding. Planned subgroup analysis of outcomes will be undertaken to identify effect at different sites and in frail versus non-frail participants.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Current
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 4079 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 4080 0
Nambour General Hospital - Nambour
Recruitment hospital [3] 4081 0
The Prince Charles Hospital - Chermside
Recruitment hospital [4] 4082 0
Caboolture Hospital - Caboolture

Funding & Sponsors
Funding source category [1] 291702 0
Government body
Name [1] 291702 0
Queensland Department of Science, Information Technology and Innovation (DSITIA)
Address [1] 291702 0
GPO Box 5078
Brisbane Qld 4001
Country [1] 291702 0
Australia
Funding source category [2] 291703 0
University
Name [2] 291703 0
Queensland University of Technology
Address [2] 291703 0
Institute of Health and Biomedical Innovation
Q Block
60 Musk Ave
Kelvin Grove Qld 4059
Country [2] 291703 0
Australia
Funding source category [3] 291704 0
Hospital
Name [3] 291704 0
Metro North Hospitals and Health Services
Address [3] 291704 0
Level 14, Block 7
Royal Brisbane and Women's Hospitals
Herston Qld 4029
Country [3] 291704 0
Australia
Funding source category [4] 291705 0
Hospital
Name [4] 291705 0
Sunshine Coast Hospital and Health Service
Address [4] 291705 0
Nambour General Hospital Block 5 Executive
PO Box 547
Nambour Qld 4560
Country [4] 291705 0
Australia
Funding source category [5] 291706 0
Hospital
Name [5] 291706 0
Hornsby Ku-Ring-Gai Health Service
Address [5] 291706 0
Palmerston Rd
Hornsby NSW 2077
Country [5] 291706 0
Australia
Primary sponsor type
Individual
Name
Professor Alison Mudge
Address
Building C28 Level 1
Roal Brisbane and Women's Hospitals
Herston Queensland 4029
Country
Australia
Secondary sponsor category [1] 290381 0
University
Name [1] 290381 0
Queensland University of Technology
Office of Research
Address [1] 290381 0
Level 4, 88 Musk Ave
Kelvin Grove Qld 4059
Country [1] 290381 0
Australia
Other collaborator category [1] 278535 0
University
Name [1] 278535 0
University of Queensland
Centre for Research in Geriatric Medicine
Address [1] 278535 0
Level 2, Building 33 Princess Alexandra Hospital
Ipswich Rd
Woolloongabba Qld 4102
Country [1] 278535 0
Australia
Other collaborator category [2] 278536 0
University
Name [2] 278536 0
University of Adelaide
School of Nursing
Address [2] 278536 0
Level 3, Eleanor Harrald Bldg
Royal Adelaide Hospital
North Terrace, Adelaide 5000
Country [2] 278536 0
Australia
Other collaborator category [3] 278537 0
University
Name [3] 278537 0
University of Melbourne
Department of Medicine
Address [3] 278537 0
Clinical Sciences Building, Royal Melbourne Hospital
Royal Parade
Parkville Vic 3050
Country [3] 278537 0
Australia
Other collaborator category [4] 278538 0
University
Name [4] 278538 0
University of Sydney
Sydney Medical School
Address [4] 278538 0
Northern Clinical School
Kolling Building, Royal North Shore Hospital
St Leonards NSW 2065
Country [4] 278538 0
Australia
Other collaborator category [5] 278539 0
Other Collaborative groups
Name [5] 278539 0
Hebrew Senior Life Centre
Institute for Ageing Research
Address [5] 278539 0
1200 Centre St
Boston
Massachussets 02131
Country [5] 278539 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293225 0
RBWH Human Research Ethics Committee
Ethics committee address [1] 293225 0
Level 7, Block 7
Royal Brisbane and Women's Hospitals
Herston Qld 4029
Ethics committee country [1] 293225 0
Australia
Date submitted for ethics approval [1] 293225 0
Approval date [1] 293225 0
01/04/2014
Ethics approval number [1] 293225 0
HREC/15/QRBW/95
Ethics committee name [2] 293226 0
QUT University Human Research Ethics Committee
Ethics committee address [2] 293226 0
Office of Research Ethics and Integrity
Level 44, 88 Must Avenue
Kelvin Grove Qld 4059
Ethics committee country [2] 293226 0
Australia
Date submitted for ethics approval [2] 293226 0
Approval date [2] 293226 0
13/05/2015
Ethics approval number [2] 293226 0
Ethics committee name [3] 293227 0
University of Queensland Ethics Committee
Ethics committee address [3] 293227 0
Ethics committee country [3] 293227 0
Date submitted for ethics approval [3] 293227 0
17/08/2015
Approval date [3] 293227 0
Ethics approval number [3] 293227 0

Summary
Brief summary
Older people (age 65 and older) account for more than half of hospital bed days, and have longer stays and more hospital adverse events that younger people. A hospital stay is often a decisive point in an older person’s health, with hospitalisation accounting for half of newly acquired disability in elders. Geriatric syndromes (including delirium, functional decline, falls, incontinence and pressure injury) result in longer hospitalisations and greater risk of death and institutionalisation. Research clearly shows that “simple” strategies (early mobilisation, adequate oral nutrition, and meaningful cognitive activities) are effective to reduce geriatric syndromes, improve outcomes and reduce costs. While such strategies have been effectively incorporated in specialist “acute care for elders” wards, only a limited number of patients have access to these specialist services. In order to optimise care we need to embed these principles in all acute wards caring for older people. However, this requires systematic changes in acute care staff attitudes, practices and systems of care.

We have piloted a programme of enabling facilitation, based on the i-PARIHS implementation framework, to embed this evidence into practice. The “Eat Walk Engage” programme supports a ward-based multidisciplinary team to identify barriers, trial solutions and embed successful strategies into practice using evidence-based quality improvement methods. In two pilot wards at the Royal Brisbane and Women’s Hospital we have shown promising reductions in length of stay, geriatric syndromes and adverse events accompanying process improvements.

The CHERISH (Collaborative for Hospitalised Elders: Reducing the Impact of Stays in Hospital) study is a cluster randomised controlled trial of the “Eat Walk Engage” programme across 4 sites, and will provide robust evidence of the transferability, scalability, effectiveness and cost-effectiveness of the programme to inform further implementation. Comparing 4 intervention wards with control wards in the same hospitals to account for other sources of variation, we aim to demonstrate a reduction in hospital stay, geriatric syndromes, and discharge to a higher level of care within 12 months of implementing the “Eat Walk Engage” programme. The project is supported by a Queensland Accelerate Partnership Grant from the Department of Science, Information Technology, Innovation and the Arts, administered by Queensland University of Technology.
Trial website
Trial related presentations / publications
Mudge A, McRae P, Cruickshank M. Eat Walk Engage: an interdisciplinary collaborative model to improve care of hospitalised elders. Am J Med Qual 2015; 30 (1):5-13
Mudge AM, Banks MD, Barnett AG, Blackberry I, Graves N, Green T et al. CHERISH (Collaboration for Hospitalised Elders Reducing the Impact of Stays in Hospital): protocol for a multi-site improvement program to reduce geriatric syndromes in older inpatients. BMC Geriatrics 2017; 17:11
Public notes

Contacts
Principal investigator
Name 56746 0
Prof Alison Mudge
Address 56746 0
Building C28 Level 1
Royal Brisbane and Women's Hospitals
Herston Queensland 4029
Country 56746 0
Australia
Phone 56746 0
61736460854
Fax 56746 0
Email 56746 0
Alison.Mudge@health.qld.gov.au
Contact person for public queries
Name 56747 0
Ms Prue McRae
Address 56747 0
Building C28 Level 1
Royal Brisbane and Women's Hospitals
Herston Queensland 4029
Country 56747 0
Australia
Phone 56747 0
61736460787
Fax 56747 0
Email 56747 0
Prue.McRae@health.qld.gov.au
Contact person for scientific queries
Name 56748 0
Prof Alison Mudge
Address 56748 0
Building C28 Level 1
Royal Brisbane and Women's Hospitals
Herston Queensland 4029
Country 56748 0
Australia
Phone 56748 0
61736460854
Fax 56748 0
Email 56748 0
Alison.Mudge@health.qld.gov.au