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Trial registered on ANZCTR


Registration number
ACTRN12615000808549
Ethics application status
Approved
Date submitted
10/12/2014
Date registered
4/08/2015
Date last updated
28/07/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Alice Springs Hospital Readmission Prevention Project: Analysis of a multi-dimensional transitional care program in patients frequently admitted to hospital
Scientific title
In patients frequently admitted to hospital does a multi-dimensional transitional care package, compared with usual care, reduce hospital readmission
Secondary ID [1] 283661 0
nil
Universal Trial Number (UTN)
U1111-1150-4169
Trial acronym
ASH RAPP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic non-communicable diseases 290613 0
Frequent hospital readmission 290614 0
Aboriginal Australian health 290615 0
Condition category
Condition code
Cardiovascular 291005 291005 0 0
Coronary heart disease
Respiratory 291006 291006 0 0
Chronic obstructive pulmonary disease
Public Health 291007 291007 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Multi-dimensional case management approach
-Comprehensive assessment to identify factors driving readmission (e.g. housing, alcohol and other drugs, social and emotional well-being): This assessment will involve a face to face, semi structured interview with the patient lasting approximately 45-60 minutes.
-Coordination of early referral to inpatient, allied services and organization of outpatient services and equipment
-Patient and carer education including diagnosis, medication use, role and access and follow-up plan: This will involve one face to face session focusing on diagnosis, a bedside session lasting 30-45mins with the team pharmacist focusing on medications and then a final session lasting 30mins with the team doctor or nurse focusing on discharge plan and follow-up
-Primary health care liaison to ensure early review within 7 days post discharge

Adherence to the intervention will be monitored by continued involvement with the program including engagement with the team during admissions, timely review with primary care and low drop out rate from the program.
Intervention code [1] 288363 0
Prevention
Comparator / control treatment
Usual clinical and hospital discharge management which involves input from individual services such as discharge planning, social work and allied health. Involvement of these services is based on referrals made by treating team. These services work independently and are not coordinated by a team or person.
Control group
Active

Outcomes
Primary outcome [1] 290987 0
Rate of all-cause readmission (calculated as readmissions/month follow-up)
-This will be assessed using data linkage with hospital medical records
Timepoint [1] 290987 0
12 months following enrolment
Secondary outcome [1] 305754 0
rate of all-cause hospital inpatient days
-This will be assessed using data linkage with hospital medical records
Timepoint [1] 305754 0
12 months following enrolment
Secondary outcome [2] 305755 0
overall rate of emergency department attendances
-This will be assessed using data linkage with hospital medical records
Timepoint [2] 305755 0
12 months following enrolment
Secondary outcome [3] 305756 0
days alive and out-of-hospital (including linkage with NT Government Death notifications)
Timepoint [3] 305756 0
12 months following enrolment
Secondary outcome [4] 305757 0
number of ICU/HDU admissions and bed days
-This will be assessed using data linkage with hospital medical records
Timepoint [4] 305757 0
12 months following enrolment
Secondary outcome [5] 305758 0
time to first primary health care review following hospital discharge
-This will be assessed using data linkage with community health records
Timepoint [5] 305758 0
12 months following enrolment
Secondary outcome [6] 305759 0
cost effectiveness
-The use of all health care resources will be measured and multiplied by the respective unit costs using the National Weighted Activity Units (NWAU). Cost for primary health care will be a fixed cost as per medicare multiplied by number of visits
Timepoint [6] 305759 0
12 months following enrolment
Secondary outcome [7] 308773 0
A prognostic assessment will be carried out by the participant's treating physician. The participant will be excluded if the median life expectancy is less than 12 months.

Accuracy of prognostic assessments
-This will be assessed using data linkage with government death notifications for patients excluded based on prognosis
Timepoint [7] 308773 0
12 months following exclusion from project

Eligibility
Key inclusion criteria
4 or more adult medical/surgical admissions over the preceding 12 months OR more than 7 admissions over the past 24 months
-A surgical admission is deemed appropriate if related to a patient's chronic disease eg. diabetic foot infections, chronic pancreatitis, cellulitis
2. Resident of Central Australia (including the cross border regions of Western Australia and
South Australia and extending north to Elliot in the Northern Territory).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Median life expectancy of 12 months or less based on independent specialist (including
subspecialist physician) assessment
2. Stage 5 chronic kidney disease (eGFR < 15ml/min or receiving renal replacement therapy)
3. Solid organ transplant (including renal transplant)
4. Ongoing palliative care service review
5. Previous enrollment in the study (such subjects will have on-going care as per original
study allocation)

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)
Total sample size will be 210, 70 randomised to case management and 140 to the control arm.
Randomisation will occur once inclusion and exclusion criteria have been reviewed and informed consent obtained from the patient. Once enrolled patients will be allocated to either the intervention or usual care groups via telephone randomization database managed by the Australian Catholic University in Melbourne. Allocations will be weighted with two patients allocated to the control group for each allocated to the intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random number sequence (Stata 13)
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/efficacy
Statistical methods / analysis
Sample size is based on data derived from Alice Springs Hospital admission data over the previous 12 months in patients who would be suitable for inclusion in this study. These data and the required sample size are based on an alpha of 0.05 and beta of 0.1 (power of 90%). In this modelling a clinically significant reduction in readmission is defined as at least a 30% reduction in total bed days or 25% reduction in number of admissions. This reduction is in line with the 40% reduction seen in earlier studies of unplanned admission reduction in heart failure patients. The total sample size (control and intervention arms) will be 210. Alice Springs Hospital data indicates more than 300 individual patients were admitted to Alice Springs hospital over the last 12
months who would meet the inclusion criteria for this study.

Statistical analysis of the primary end point will be based on univariate analysis for continuous variables for inpatient days and chi square and survival analysis for all cause mortality. Multivariate analysis will be utilised to develop predictive equations for risk of readmission and survival utilising baseline data including self-reported (Resource Utilization Groups– Activities of Daily Living (RUG-ADL)] and Australian Modified Karnofsky Performance Scale (AKPS)) and objective (6MWT) measures of function, co-morbidities (including severity), demographics and anthropometry.

Health economic analyses will assess the use of all
health care resources multiplied by the respective unit costs. In general, hospital admissions typically incur higher costs for the initial period when diagnostic tests and surgical procedures are undertaken. The later days stay are relatively lower cost with little more than hotel costs incurred. The use of Australia-refined Diagnostic Related Groupings (AR-DRGs) will permit us to standardise and categorise each rehospitalisation episode into fixed and variable costs. Fixed costs are those that all surviving patients incur irrespective of their length of stay, whilst variable costs are a per diem cost and are dependent on the length of stay. The total costs are the variable costs multiplied by the length of stay plus the fixed cost. Fixed costs will include
components for the emergency department, pathology, imaging, allied health professional input, pharmacy, critical care, prostheses, operating room procedures and specialist procedure suites. Per diem costs will include those for medical staff, nursing staff, non-clinical staff, staff on-costs, supplies, hotel costs (e.g. meals), and depreciation. We will also collect length of stay in intensive care and critical care units (ICU/CCU), as well overall length of stay. Accordingly, costs will be calculated using fixed costs plus the mean per diem cost for ICU/CCU (equivalent 2012 costs - AU$3356) plus the per diem cost for a general ward (AU$772) multiplied by the lengths of stay in each facility. Further, other resources used for implementing the intervention and usual care in regard to discharge planning and readmission prevention and community care including primary
health care services will be multiplied by the respective unit costs; these will be derived from contemporary sources in 2014

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Other reasons/comments
Other reasons
Positive results from an interim analysis and a potential survival benefit identified
Date of first participant enrolment
Anticipated
29/06/2015
Actual
29/06/2015
Date of last participant enrolment
Anticipated
30/06/2017
Actual
30/06/2017
Date of last data collection
Anticipated
19/08/2017
Actual
Sample size
Target
210
Accrual to date
Final
113
Recruitment in Australia
Recruitment state(s)
NT
Recruitment hospital [1] 1769 0
Alice Springs Hospital - Alice Springs
Recruitment postcode(s) [1] 7588 0
0870 - Alice Springs

Funding & Sponsors
Funding source category [1] 288350 0
Government body
Name [1] 288350 0
NHMRC
Country [1] 288350 0
Australia
Primary sponsor type
Other
Name
Baker IDI Heart and Diabetes Institute
Address
75 Commercial Rd
Melbourne Victoria 3004
Country
Australia
Secondary sponsor category [1] 287059 0
None
Name [1] 287059 0
Address [1] 287059 0
Country [1] 287059 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290234 0
Central Australian Human Research Ethics Committee
Ethics committee address [1] 290234 0
Ethics committee country [1] 290234 0
Australia
Date submitted for ethics approval [1] 290234 0
Approval date [1] 290234 0
13/11/2013
Ethics approval number [1] 290234 0
HREC-13-159

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

Contacts
Principal investigator
Name 44594 0
A/Prof Graeme Maguire
Address 44594 0
Baker IDI Central Australia
PO Box 1294
Alice Springs NT 0871
Country 44594 0
Australia
Phone 44594 0
+61 8 8951 0111
Fax 44594 0
+61 8 8952 1557
Email 44594 0
graeme.maguire@bakeridi.edu.au
Contact person for public queries
Name 44595 0
Graeme Maguire
Address 44595 0
Baker IDI Central Australia
PO Box 1294
Alice Springs NT 0871
Country 44595 0
Australia
Phone 44595 0
+61 8 8951 0111
Fax 44595 0
+61 8 8952 1557
Email 44595 0
graeme.maguire@bakeridi.edu.au
Contact person for scientific queries
Name 44596 0
Graeme Maguire
Address 44596 0
Baker IDI Central Australia
PO Box 1294
Alice Springs NT 0871
Country 44596 0
Australia
Phone 44596 0
+61 8 8951 0111
Fax 44596 0
+61 8 8952 1557
Email 44596 0
graeme.maguire@bakeridi.edu.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

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

Documents added automatically
No additional documents have been identified.