Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000187943
Ethics application status
Approved
Date submitted
16/02/2011
Date registered
17/02/2011
Date last updated
30/10/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Aged Residential Care Healthcare Utilization Study (ARCHUS) - a randomised cluster trial of multi-disciplinary clinical teams supporting nursing home staff to provide evidence-based care in order to reduce hospitalisations of residents.
Scientific title
Multi-disciplinary teams supporting nursing home staff to provide evidence-based care in order to avoid hospitalisations of residents, compared to usual care.
Secondary ID [1] 253613 0
None
Universal Trial Number (UTN)
Trial acronym
ARCHUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic and acute conditions of older people living in residential care facilities that lead to acute admissions to hospital that are potentially avoidable, eg through earlier identification, better management, or up-skilling of facility staff. 261172 0
Condition category
Condition code
Public Health 259326 259326 0 0
Health service research
Public Health 259339 259339 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Multidisciplinary teams to support and up-skill facility staff using evidence-based quality improvement interventions.

The supports and services provided will comprise an initial stock-take assessment and development of a facility plan, direct access to a geriatrician and to a geriatric or clinical nurse specialist, multi-disciplinary team meetings to discuss individual cases, provision of targeted education to facility nurses and caregivers (topics include recognition of illness, wound care, care planning, end-stage dementia care, nutrition & dehydration, effective family communication), specific coaching with high-risk residents, role modeling of clinical reasoning processes, and provision of benchmarking systems. Facilities will receive 9 months of the intervention.

The unit of selection, randomisation and intervention is the facility. The unit of measurement of outcomes is the residents of the participating facilities.

Recruitment and randomisation: February to June 2011. Active interventions will be completed by February 2012.
Intervention code [1] 258035 0
Early detection / Screening
Intervention code [2] 258036 0
Prevention
Intervention code [3] 258037 0
Other interventions
Comparator / control treatment
Usual services and supports from district health boards to those facilities providing residential aged care.

Some training and supports are provided by the DHBs, and each of the 3 DHBs currently does things differently. Some variations of some of these interventions have been implemented in each DHB, but not as fully or systematically as this, and in a non-targeted way. GNS/CNS visit some facilities, and geriatricians are consulted only in very unusual circumstances.
Control group
Active

Outcomes
Primary outcome [1] 262128 0
Rate of ambulatory care-sensitive hospitalisations (ASH admissions).

Routinely-collected data in nationally-collected databases for all hospital stays will be used. A pre-determined set of ICD codes is used to classify all hospital stays as "ASH" or not. Admission will be included if both since randomisation and since entry of the resident to the facility.
Timepoint [1] 262128 0
Period from date of randomisation to 14 months after first visit by study staff. Hospitalisation records will be sought after 6 months of the intervention in order to get analysis code prepared, then again 5 months after the final facility completes its intervention, in order to allow for any delays in registering admissions. Paper reports from each participating facility will enable some checking against national records.
Primary outcome [2] 262131 0
Number of (emergency admission) hospital days per occupied bed per year

as for Endpoint 1 above - records are held nationally for all stays.
Timepoint [2] 262131 0
14+ month period commencing on date of randomisation as for Endpoint 1 above
Primary outcome [3] 262132 0
number of deaths from any cause, including death in acute hospital or elsewhere

Deaths are also recorded in the national database and will be included with the admissions data.
Timepoint [3] 262132 0
14+ month period commencing on date of randomisation as for Endpoint 1 above
Secondary outcome [1] 273210 0
Number of emergency department presentations per bed per year

ED visits data are also now available on our national database and will be obtained with the other data
Timepoint [1] 273210 0
14+ month period commencing on date of randomisation as for Endpoint 1 above
Secondary outcome [2] 273211 0
number of medications prescribed per bed per year

Subsidised medications are now listed on the regional databases. We will use pre-specifed groupings that we have derived and that are related to ASH admissions.
Timepoint [2] 273211 0
14+ month period commencing on date of randomisation as for Endpoint 1 above

Eligibility
Key inclusion criteria
The unit of selection, randomisation and intervention is the facility. Facilities providing residential aged care within the greater Auckland region are selected for the trial if they have higher than expected rates of hospitalisation (given number of beds, age of residents etc).
All residents living in the participating facilities during the intervention period will be included for the purposes of measuring outcomes.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

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)
At the commencement of the trial, facilities are selected based on risk modeling, and stratified by health region (DHB). After informed consent is obtained and baseline data are collected, the facilities are presented pairwise to the randomisation process, matched by type of facility and approximate number of beds.
Randomisation will be progressive, ie 4-6 facilities per month for a period of nine months.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
One of each pair is randomly allocated to the intervention for 9 months starting in the year 2011. The other will have usual services and supports from their DHB during 2012, and will receive the intervention starting 14 months later, ie starting 2012 (for purposes of recruitment, not for comparison).
To achieve this, each facility is electronically ascribed a random number using a random number generator. Another random number list (3, one for each DHB stratum) shows 2011 (active) / 2012 (control) as the intervention year. The facility with the lower random number (in the pair) is allocated to the next listed intervention (ie 2010 or 2011). The facility with the higher random number is allocated the other. Random allocation will be made only by the scientific member of the investigatory team and the data manager, will be held in secure files and advised to the project manager confidentially. Data will be collected using facility IDs, not names, and the treatment coded as 1 or 2 during analyses.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
The intervention is a multi-disciplinary team providing supports to facility staff, so the allocation of active facilities has to be known. The design is a cluster trial in that although the facility is the unit of intervention (n= 36), outcomes are measured with residents as the unit of measurement (n =c. 1400). Every effort is being made to not reveal (to other members of the research team or to other facilities) which are the control facilities (ie the 2011 facilities). The investigators are not advised of the identity of participating facilities. The project manager, who recruits, obtains informed consent and collects monitoring data, has been asked not to reveal the identify of facilities during or outside investigators meetings. Endpoints are collected by use of routinely collected data for hospital admissions and discharges, deaths and subsided medications, so are unaffected by the trial design.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Primary end-points analysed using rerandomisation methods of study endpoints summarised at facility level, adjusted for resident follow-up time.
Pre-specified sub-group analyses using same rerandomisation methods.
Sensitivity analyses using multivariate regression techniques.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/02/2011
Actual
24/02/2011
Date of last participant enrolment
Anticipated
16/05/2012
Actual
1/08/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
36
Recruitment outside Australia
Country [1] 3204 0
New Zealand
State/province [1] 3204 0
Auckland

Funding & Sponsors
Funding source category [1] 258510 0
Government body
Name [1] 258510 0
Health Research Council of New Zealand
Country [1] 258510 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
The University of Auckland
Faculty of Medical and Health Sciences
Private Bag 92019
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 257647 0
Government body
Name [1] 257647 0
Waitemata District Health Board
Address [1] 257647 0
Private Bag 93-503
Takapuna
Auckland 0740
New Zealand
Country [1] 257647 0
New Zealand
Secondary sponsor category [2] 257650 0
Government body
Name [2] 257650 0
Auckland District Health Board
Address [2] 257650 0
Private Bag 92024
Auckland Mail Centre
Auckland 1142
Country [2] 257650 0
New Zealand
Secondary sponsor category [3] 257651 0
Government body
Name [3] 257651 0
Counties Manukau District Health Board
Address [3] 257651 0
Private Bag 94052
South Auckland Mail Centre
Manukau 2240
Country [3] 257651 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260482 0
Northern Region Ethics Committee Y
Ethics committee address [1] 260482 0
Ethics committee country [1] 260482 0
New Zealand
Date submitted for ethics approval [1] 260482 0
Approval date [1] 260482 0
21/01/2011
Ethics approval number [1] 260482 0
NTY/10/11/090

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32219 0
Prof Martin J Connolly
Address 32219 0
Freemasons’ Department of Geriatric Medicine, North Shore C/- Waitemata DHB Private Bag 93503 Takapuna 0740 Auckland
Country 32219 0
New Zealand
Phone 32219 0
+64 9 442 7146
Fax 32219 0
+64 9 442 7166
Email 32219 0
[email protected]
Contact person for public queries
Name 15466 0
Martin J Connolly
Address 15466 0
Freemasons’ Department of Geriatric Medicine, North Shore
C/- Waitemata DHB
Private Bag 93503
Takapuna 0740
Auckland
Country 15466 0
New Zealand
Phone 15466 0
+64 9 442 7146
Fax 15466 0
+64 9 442 7166
Email 15466 0
[email protected]
Contact person for scientific queries
Name 6394 0
Martin J Connolly
Address 6394 0
Freemasons’ Department of Geriatric Medicine, North Shore
C/- Waitemata DHB
Private Bag 93503
Takapuna 0740
Auckland
Country 6394 0
New Zealand
Phone 6394 0
+64 9 442 7146
Fax 6394 0
+64 9 442 7166
Email 6394 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAged Residential Care Health Utilisation Study (ARCHUS): a randomised controlled trial to reduce acute hospitalisations from residential aged care.2012
EmbaseThe 'Big Five'. Hypothesis generation: A multidisciplinary intervention package reduces Disease-Specific hospitalisations from Long-Term care: A post hoc analysis of the ARCHUS Cluster-Randomised controlled trial.2016https://dx.doi.org/10.1093/ageing/afw037
N.B. These documents automatically identified may not have been verified by the study sponsor.