Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000907741
Ethics application status
Not yet submitted
Date submitted
12/08/2013
Date registered
14/08/2013
Date last updated
23/07/2019
Date data sharing statement initially provided
23/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Prevention of avoidable hospital admissions of older people living at home in Western Australia: a pilot randomized control trial.
Scientific title
Prevention of avoidable hospital admissions of older people living at home in Western Australia: a pilot randomized control trial.
Secondary ID [1] 282990 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
PrAHA study.
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Older population at risk of hospital admission as determined by recent admission history. 289816 0
Condition category
Condition code
Public Health 290167 290167 0 0
Health promotion/education
Public Health 290168 290168 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a multidisciplinary assessment of the physical, psychological and social needs of patients considered at risk of hospital admission and or Emergency department attendance. An initial audio recorded consultation with a community nurse will be played to the team to assist them in their recommendations. The assessment, which will also be informed by the nurse's observations will be shared with the patient's general practitioner and the general practitioner will determine if further medical intervention is warranted. All actions taken in response to the recommendations will be monitored via data linkage to the patient's medical records.
Intervention code [1] 287704 0
Early detection / Screening
Intervention code [2] 287705 0
Rehabilitation
Intervention code [3] 287706 0
Prevention
Comparator / control treatment
To determine whether there is a difference in hospital admission rates between those receiving intervention and those in the usual practice arm. In usual practice the patient is not formally assessed by a multidisciplinary team.
Control group
Active

Outcomes
Primary outcome [1] 290196 0
Hospital admission rates and attendance at Emergency department. ( composite primary outcome).
Timepoint [1] 290196 0
at 12 months after intervention by data linkage to the patient medical records.
Secondary outcome [1] 304086 0
Duration of hospital admission
Timepoint [1] 304086 0
at 12 months after intervention by data linkage to the patient medical records.

Eligibility
Key inclusion criteria
People aged 75 years and above, living in private accommodation in Western Australia and at risk of unplanned hospital attendance.
Minimum age
75 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People below 75 years of age

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)
A list of all people aged 75 years and older attending a large medical practice with 28 General Practitioners in Western Australia (Murray Medical Centre - MMC) and living in private accommodation will be generated (List A). MMC has 1831 active files on patients over 75 years.

On the basis of a previous study in primary care it is anticipated that 18 % will be at risk of hospital admission or Emergency Department (ED) attendance, 329 patients (List B).

The at-risk status will be defined as those patients who have attended ED or been admitted to hospital in the previous year. This list will be generated from the practice records and from data received via the local hospital. The list will be reviewed and their general practitioners and the Silver Chain nurse (Community nurse) will be invited to identify those who are considered at on-going risk of further unplanned hospital attendance in the following year with reference to their medical and nursing records supplemented by the practitioners' knowledge of the patient, their carer and home circumstances (List c- possibly 250 names).

Assignment to group:
120 patients on List C will be consented to participate (List D). These participants will be randomly assigned; using a computer generated random number, to an experimental or a control group (60 in each group). The patients in the control group will be offered the intervention if it is found to be successful at the end of the study.

Allocation concealment: The researcher who will determine if a subject is eligible for inclusion in the trial will be unaware, when this decision is made, to which group the subject will be allocated. Allocation will be concealed as it will be done by central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The study will be randomized using a randomization table created by computer software (i.e. computer sequence generation). The randomization will be performed using a permuted random blocking strategy, so that the numbers will accumulate to each arm of the study at an approximately equal rate.

The total of 120 participants enrolled in the study will be randomized using this computer software into two arms.

Arm 1: Receive Intervention
Arm 2: Control Group
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size:
Ina previous study the at-risk group (59 patients) was admitted to hospital 19 times in the year before intervention. On this basis a sample of 120 people will have been admitted 38 times. A reduction in the hospitalization rate by 50% would be clinically significant. A sample size of at least 111 in each group would be required to demonstrate a drop to 16% chance of admission with 80% power and an alpha of 0.05. In this pilot study, we propose to use half this size, as this will give an indication of the effect size, and provide information about the feasibility of the intervention. We propose to recruit a total sample size of 60 in each group. For a regression model the commonly used principle is that the sample should be a minimum of approximately n=120, in order to detect an association with an independent variable which demonstrates a 'moderate' effect size.

Analysis methods:
We will use simple descriptive statistics to compare the 2 groups at baseline, on the grounds of their demographic and health profile. We will use Chi-square statistics or t-tests as appropriate to assess the significance of any difference between groups.

We will compare the 2 groups (intervention and control) on the basis of number of admissions and total days of admission using a Poisson Regression model. The independent variables for the regression model will be the group, and the results will be presented as the expected number of admissions per person in each group, along with its 95% confidence interval and p-value to compare groups. If the distribution of the secondary outcome (number of days admitted) is not Normal, we may transform it before analysis with a t-test (most probably log-transformed).

In order to assess whether the intervention is particularly effective in any sub group of subjects, the regression model will be extended to include demographic or health profile descriptors as independent variables. The t-test for the secondary outcome will be extended to a regression model to examine similar dependencies with other independent variables.

Statistical analyses will be performed using the SPSS statistical software, and a p-value< 0.05 will be taken to indicate a statistically significant association.

We will capture data on both the cost and effectiveness of the intervention and control groups. The study will compare the difference in costs and difference in effectiveness of the intervention and control groups. The evaluation will be carried out from the perspective of the health services, which includes both Medicare and non-Medicare health related costs over the period of the trial. Resource use data will be collected to estimate the costs associated with the different models of care. Effectiveness will be measured in terms of hospital event avoided. The incremental difference mean difference in costs between the two trial arms and incremental difference in hospital admissions will be calculated and we will calculate an incremental cost effectiveness ratio of cost per hospital admission avoided.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
4/11/2013
Actual
Date of last participant enrolment
Anticipated
29/11/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 7262 0
6210 - Mandurah

Funding & Sponsors
Funding source category [1] 287760 0
University
Name [1] 287760 0
Curtin University
Country [1] 287760 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Curtin University, Building 609, 7 Parker Place, Technology Park, Bentley 6102, WA
Country
Australia
Secondary sponsor category [1] 286486 0
None
Name [1] 286486 0
Address [1] 286486 0
Country [1] 286486 0
Other collaborator category [1] 277570 0
Charities/Societies/Foundations
Name [1] 277570 0
Silver Chain Group
Address [1] 277570 0
Silver Chain House, 6 Sundercombe Street, Osborne Park WA 6017
Country [1] 277570 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289709 0
Curtin University Human Rsearch Ethics Committee
Ethics committee address [1] 289709 0
HREC office, Curtin University, Bentley campus, Building 100, level 1, Kent street, Bentley 6102, WA
Ethics committee country [1] 289709 0
Australia
Date submitted for ethics approval [1] 289709 0
31/07/2013
Approval date [1] 289709 0
Ethics approval number [1] 289709 0

Summary
Brief summary
There is published evidence for avoidable hospital admission of older people. However no effective intervention has been adopted as routine practice. A pilot randomized controlled trial is proposed for initial evaluation of a complex intervention, comprising multidisciplinary input into the care of older people at risk of hospital admission for unmet need. Older people will be identified by a review of admission records and further described using a set of measures assessing for physical, social and psychological needs. The needs of those assigned to receive the intervention will be reviewed and addressed by a general practitioner supported by a multidisciplinary team. The study will generate data on:

1)Identifying and engaging at-risk patients
2)Operating a multidisciplinary team- including primary care practitioners who are not formally employed in general practice
3)The relevant interventions that are funded by Medicare and the logistics of delivering those interventions
4)The uptake of such interventions by patients
5)Developing the role of GP as care coordinator within a multidisciplinary team structure.

This project will address the recommendations of a recent Cochrane review on reducing hospital admissions. The intervention will be developed with reference to published Australia data and the UK Medical Research Council framework for the development and evaluation of complex interventions. This pilot study is a forerunner to a multi-centered, fully powered randomized controlled trial.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes
Nil

Contacts
Principal investigator
Name 42066 0
Prof Moyez Jiwa
Address 42066 0
Curtin University- Department of Medical Education
GPO Box U1987, Perth WA 6845
Country 42066 0
Australia
Phone 42066 0
+61 8 9266 1768
Fax 42066 0
+61 8 9266 2508
Email 42066 0
[email protected]
Contact person for public queries
Name 42067 0
Gill Lewin
Address 42067 0
Curtin Health Innovation Research Institute (CHIRI)- Ageing and Centre for Research on Ageing
GPO Box U1987, Perth WA 6845
Country 42067 0
Australia
Phone 42067 0
+61 8 9266 1829
Fax 42067 0
+61 8 9266 2508
Email 42067 0
[email protected]
Contact person for scientific queries
Name 42068 0
Moyez Jiwa
Address 42068 0
Curtin University- Department of Medical Education
GPO Box U1987, Perth WA 6845
Country 42068 0
Australia
Phone 42068 0
+61 8 9266 1768
Fax 42068 0
+61 8 9266 2508
Email 42068 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
trial not proceeding


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.