Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000486921
Ethics application status
Approved
Date submitted
4/04/2011
Date registered
10/05/2011
Date last updated
10/05/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The PASS study: A performance assessment system for success in residential aged care
Scientific title
Performance assessment system for success (PASS) in residential aged care
Secondary ID [1] 259628 0
None
Universal Trial Number (UTN)
Trial acronym
The PASS trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Quality of care 265517 0
Condition category
Condition code
Public Health 265687 265687 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Three monthly benchmarking information for selected quality indicators provided at month six then three monthly to month 15 to both arms of the study. In addition quality improvment activites interventions were provided to the intervention arm including: one individual site visit by an advanced practice gerontological nurse to explain the benchmarking; how the results could be used to improve resident outcomes and provide support with the intervention; a best practice quality tool kit for the prevention harm; voiced over power point education sessions of best practice in the prevention of harm that could be used at any time by facility staff and two quality forums by telephone conferencing. the intervention was implemented after six months of data collection over a three month period. The resources provided were designed to be able to be used by the hospital over the final 6 months of the study as well
Intervention code [1] 264332 0
Treatment: Other
Comparator / control treatment
Three monthly benchmarking information for selected quality indicators provided at month 6, 9,12 and 15. Quality indicator for fall, pressure ulcers, restraint use, urinary tract infections and indwelling urinary catheters was analysed using means for each facility and graphed. The three monthly benchmarking reports were placed on the password protected website for ease of access by the facilities. The facilites identified their data by their confidential research ID. All particpants were able to access webiste for the benckmarking reports.
At months 6 and 15 staffing hours per resident per day for all direct care staff were benchmarked and a Shortells staff survey was also benchmarked at months 6 and 15.
Control group
Active

Outcomes
Primary outcome [1] 266446 0
Reduction in adverse outcomes for the residents in residential aged care hospitals from pre to post intervention as measure by significance for the quality improvement activities group measured at individual resident level
Timepoint [1] 266446 0
6 months pre intervention of data collection, 3 months intervention and 6 months post intervention of data collection
Secondary outcome [1] 273794 0
Reduction in adverse outcomes for the residents in residential aged care hospitals from pre to post intervention as measure by significance for the benchmarking measured at individual resident level
Timepoint [1] 273794 0
6 months pre intervention of data collection, 3 months intervention and 6 months post intervention of data collection

Eligibility
Key inclusion criteria
All RAC providers that were listed as a’ hospital’ from the Northland, Waitemata, Auckland, Counties Manukau, Waikato, and the Bay of Plenty District Health Boards on the Ministry of Health certification list, June 2008 and held an Age Related Residential Care Service Provider Agreement with their local District Health Board and provided continuing hopsital level care.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Continuing care Hospitals operated by District Health Boards were excluded as they have additional funding streams and different case mix.

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)
Continuing care hospitals were recruited, rather than individual residents, as the intervention was focused on influencing the actions of staff in caring out care processes provided to residents. To ensure that the sampling frame was as large as possible it was decided to invite all 137 eligible continuing hospitals to participate. once recruitment was completed and consents were obtained blinding of researchers to allocation status was achieved by providing a biostatistician with the participants’ research numbers and the number of beds in each facility and she undertook the process of cluster randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Cluster randomisation was used to achieve a probability sampling strategy that involved successive random sampling of the hospitals progressing from large to small in bed numbers. Cluster sampling requires computing the mean for the individual sampling unit and multiplying this by the number of units in the population to determine the population's estimated value. The precision limit on this estimate was also be computed.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 3208 0
New Zealand
State/province [1] 3208 0
Auckland

Funding & Sponsors
Funding source category [1] 264796 0
University
Name [1] 264796 0
University of Auckland
Country [1] 264796 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
The School of Nursing
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland Mail Centre 1142, New Zealand
Country
New Zealand
Secondary sponsor category [1] 263908 0
None
Name [1] 263908 0
Address [1] 263908 0
Country [1] 263908 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266770 0
New Zealand Ministry of Health Multi-Regional Ethics Committee
Ethics committee address [1] 266770 0
Ethics committee country [1] 266770 0
New Zealand
Date submitted for ethics approval [1] 266770 0
01/04/2008
Approval date [1] 266770 0
01/05/2008
Ethics approval number [1] 266770 0
MEC/08/16/EXP

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

Contacts
Principal investigator
Name 32232 0
Address 32232 0
Country 32232 0
Phone 32232 0
Fax 32232 0
Email 32232 0
Contact person for public queries
Name 15479 0
Noeline Whitehead
Address 15479 0
1/38 Tawhiri Rd
One Tree Hill
Auckland 1061
Country 15479 0
New Zealand
Phone 15479 0
64 9 6366296
Fax 15479 0
Email 15479 0
[email protected]
Contact person for scientific queries
Name 6407 0
Noeline Whitehead
Address 6407 0
1/38 Tawhiri Rd
One Tree Hill
Auckland 1061
Country 6407 0
New Zealand
Phone 6407 0
64 9 6366296
Fax 6407 0
Email 6407 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
No additional documents have been identified.