Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000121662
Ethics application status
Approved
Date submitted
22/12/2022
Date registered
6/02/2023
Date last updated
6/02/2023
Date data sharing statement initially provided
6/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A Systems aPproach to community-based medIcation REview for people at risk of medication harm after a hospital stay: ASPIRE trial
Scientific title
A stepped wedge cluster randomised trial to compare the effect of A Systems aPproach to community-based medIcation REview with usual care on unplanned, all-cause hospital readmissions in people at risk of medication harm after a hospital stay: ASPIRE trial
Secondary ID [1] 308570 0
MRFQI000043
Issuing authority: Australian Government Medical Research Future Fund
Universal Trial Number (UTN)
U1111-1285-8528
Trial acronym
ASPIRE
(A Systems aPproach to enhancing community-based medIcation REview)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
polypharmacy 328428 0
medication error 328429 0
inappropriate prescribing 328430 0
multimorbidity 328432 0
medication non-adherence 328433 0
preventable hospitalisations 328434 0
Condition category
Condition code
Public Health 325452 325452 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a systems-based collaborative model to improve timely access to, and enhance the effectiveness of, the existing government-funded medication review services for people at risk of medication harm after a hospital stay. The medication review services include Home Medicines Review (HMR) and Residential Medication Management Review (RMMR), which are funded by the Australian Government and provided by GPs and accredited pharmacists.

The model is targeted at the local health system level. Co-adaptation workshops will be held at each centre involving hospital and primary care healthcare practitioners and consumers to tailor the intervention to suit local systems and resources.

The trial has a stepped wedge randomised cluster design with four trial centres (‘clusters’), each consisting of a hospital and associated primary healthcare network (PHN). Patient participants aged 45 years and over who at high risk of medication harm according to a screening tool and clinical assessment, will be recruited at the hospitals within 72 hours of their anticipated discharge date, over a 24-month period. The total trial duration is 27 months.

Trial centres will provide usual care (comparator treatment) until the time at which they have been randomised to start the intervention. The control phase at each centre will be 5, 9, 13 or 17 months in duration, depending on the random allocation of the centre. There will be a 2-month transition phase (lead-in period) to embed the intervention; data collected from this period will be excluded from the analysis. During the control phase, coadaptation workshops will be held at each centre with local healthcare practitioners and other stakeholders to identify local systems (e.g. information transfer, communication preferences) and adaptations required to implement the intervention at that centre.

Participants will be blinded to the phase of the trial, but healthcare practitioners and researchers will not.

PHNs are independent organisations funded by the Australian Government to coordinate primary healthcare in a region.

There are five core components of the intervention, which are designed to address both the key limitations of the existing HMR and RMMR programs and the core contributors to post-discharge medication problems:
1. A research assistant (study pharmacist or study nurse) will be employed by, and located at, each hospital to identify people who may benefit from a post-discharge medication review, applying clinical judgement in consultation with the clinical team, and using a screening tool, developed specifically for this trial. The research assistant will apply the screening tool to pre-screen electronic medical records of patients anticipated to be discharged within the next 72 hours, and they will conduct a short patient interview (15 minutes) to verify eligibility against the tool. Audits of data entry against electronic medical records will be conducted by the study coordinator for random participant samples at trial commencement, at 10% participant accrual, 6-monthly and at the close of the trial.

2. A Medication Safety Hub (MSH) will be implemented in each PHN with an appointed Medication Safety Pharmacist to coordinate timely post-discharge medication review services. Patient participation in medication reviews will be derived from Medicare Benefits Schedule (MBS) claims data and verified by follow up participant telephone survey at 90 days.

3. Communication channels will be established between the PHN-based Medication Safety Pharmacist (MSP) and local hospital and primary care healthcare practitioners to support coordination of medication review services. MSP diaries and email records will be used to assess fidelity.

4. Multidisciplinary continuing professional development (CPD) events on quality use of medicines topics will be run by the PHN MSH for local hospital and primary care healthcare practitioners. The objective will be to foster a collaborative patient-centred approach to optimising medicines use and improving medication safety in the PHN and across transitions of care. GPs, junior medical officers, community pharmacists and hospital pharmacists will be invited to 60-to-90-minute events held at least every 8 weeks over the duration of the intervention phase. Events will have a case study format. Identification of appropriate quality indicators for GPs to help identify participants who may benefit from a medication review will also be covered. Topics will be informed by local needs, and the delivery mode (e.g. face-to-face, video-conferencing) suited to local preferences. The number of healthcare practitioners attending will be collected using session attendance lists.

5. A communication strategy will be implemented to raise awareness among local hospital and primary care healthcare practitioners of the new role of the PHN in coordinating medication reviews and medication safety initiatives, and the importance of timely post-discharge medication review. The strategy will be tailored to local needs and existing communication tools of the centre and developed during the co-adaptation workshops.

Up to 72 hours before being discharged from hospital, a patient enrolled during the intervention phase of the study will:
• Participate in a single 15-minute session in which the research assistant (study pharmacist or nurse) will provide oral and written information on medication review (ie, NPS Medicinewise Factsheet ‘How a medicine review in your home can help you get the most from your medicines’) and the opportunity to ask questions. The information will include what is a medication review, possible benefits, what’s involved (e.g. a 1-hour interview by a pharmacist), who can do a medication review, and cost.
• Be encouraged by the research assistant (study pharmacist or nurse) to visit their GP soon after discharge (within the hospital’s recommended time), to take along their discharge summary letter, and to ask their GP about a medication review
• Have the request for a medication review communicated separately to their GP (by phone or secure email) by the PHN Medication Safety Pharmacist
They may also have their hospital clinical team include a written recommendation for a medication review in their discharge summary letter to their GP with any additional information to support a review.

After arriving home, a patient enrolled during the intervention phase of the study may:
• Be offered a medication review by their GP during their GP consultation.
• Be referred by their GP to an accredited pharmacist for a medication review (HMR or RMMR). If referred, there may be a separate communication made on their behalf by the PHN Medication Safety Pharmacist to the accredited pharmacist with any additional information about the individual’s medicines to assist them carry out the HMR or RMMR.

If offered a HMR or RMMR by their GP, a patient enrolled during the intervention phase of the study will receive a medication review in accordance with the existing HMR and RMMR program guidelines, and the usual practices of their GP and the accredited pharmacist.

Key HMR/RMMR steps in the funded HMR and RMMR programs are:
• The HMR or RMMR is conducted by a participating accredited pharmacist together with the patient (face-to-face, where possible) in their own home or at the residential aged care home. The pharmacist assists the risks and benefits of each medicine, the complexity of the regimen and how the patient is managing their medicines. They identify ways to improve the patient's adherence to their medicines, reduce medication error and resolve medicine-related problems, and they make recommendations to the patient's GP to reduce the risk of harm and optimise the benefit the patient receives from their medicines.
• The accredited pharmacist provides a report of the HMR or RMMR with recommendations about ongoing therapy to the patient’s GP and community pharmacy.
• The GP contacts the patient on receipt of the report and ask them to make an appointment.
• The GP and the patient review the pharmacist’s report together at the GP's practice. Together they develop a medication management plan using the report as the basis, considering which, if any, recommendations should be acted on.
Intervention code [1] 325053 0
Prevention
Intervention code [2] 325054 0
Treatment: Other
Comparator / control treatment
Individuals will receive usual care provided by the hospital and their GP. Usual care would generally involve the individual being discharged from hospital with a 5 to 7- day supply of medicines and a discharge summary letter for their GP listing their current medicines and/or changes to their medicines.
Control group
Active

Outcomes
Primary outcome [1] 333370 0
The proportion of people with at least one unplanned all-cause readmission to hospital in the intervention group compared to control /usual care.

Data linked from state hospital admitted patient care data collections will be assessed to determine the number of unplanned hospital readmissions.
Timepoint [1] 333370 0
90 days after discharge
Secondary outcome [1] 416787 0
The proportion of people with at least one unplanned all-cause readmission to hospital in the intervention group compared to control/usual care.

Data linked from state hospital admitted patient care data collections will be assessed to determine the number of unplanned hospital readmissions.
Timepoint [1] 416787 0
28 days after discharge
Secondary outcome [2] 416795 0
The proportion of people with at least one emergency department (ED) presentation in the intervention group compared to control/usual care.

Data linked from state emergency department data collections will be assessed to determine the number of ED presentations.
Timepoint [2] 416795 0
28 days and 90 days after discharge
Secondary outcome [3] 416798 0
The number and proportion of people who had a post-discharge Medication Management Review in the intervention group compared to control/usual care

Medicare Benefits Schedule (MBS) data will be used as the source.
Timepoint [3] 416798 0
90 days after discharge
Secondary outcome [4] 416799 0
Changes in health status, using the EQ-5D-5L instrument, in the intervention group compared to control/usual care
Timepoint [4] 416799 0
90 days after discharge
Secondary outcome [5] 416800 0
Changes in medication-related burden (MRB), using the MRB-QoL instrument, in the intervention group compared to control/usual care
Timepoint [5] 416800 0
90 days after discharge
Secondary outcome [6] 416801 0
Change in the total number of distinct medicines in individual medication lists (medicines recorded or dispensed) in the intervention group compared to control/usual care

Electronic medical record data (discharge summary letters) will be the source of medication lists at the time of discharge. Dispensing data from the Pharmaceutical Benefits Scheme/Repatriation Pharmaceutical Benefits Scheme (PBS/RPBS) and medication lists from GP records will be triangulated to derive the 90-day post-discharge medication list.

Medicines will be determined as distinct according to the Anatomic Therapeutic Chemical (ATC) Classification 5th level
Timepoint [6] 416801 0
90 days after discharge
Secondary outcome [7] 416802 0
Change in the number of distinct medicines in individual medication lists that are categorised as high risk in the intervention group compared to control/usual care.

Electronic medical record data (discharge summary letters) will be the source of medication lists at the time of discharge. Dispensing data linked from the Pharmaceutical Benefits Scheme/Repatriation Pharmaceutical Benefits Scheme (PBS/RPBS) and medication lists from GP records will be triangulated to derive the 90-day post-discharge medication list.

Medicines will be determined as distinct according to the Anatomic Therapeutic Chemical (ATC) Classification 5th level

Definitions
High risk medicines include but are not limited to insulins, anticoagulants, oral hypoglycaemics, dual antiplatelet therapy, digoxin, opioids, oral cytotoxics, sedatives, hypnotics, anxiolytics, antipsychotics, anticholinergic medicines
Timepoint [7] 416802 0
90 days after discharge
Secondary outcome [8] 416824 0
Healthcare utilisation associated with the intervention (composite outcome)

This will be evaluated in terms of healthcare use in the intervention group compared with control/usual care, adjusted for healthcare use prior to the intervention.

Data from state and federal health record databases will be assessed to determine number of:
- unplanned hospital readmissions
- ED presentations
- GP visits, HMR, RMMR and other Medicare Benefits Schedule (MBS) services
- Pharmaceutical Benefits Scheme/Repatriation Pharmaceutical Benefits Scheme medicines dispensing claims
- Vaccination use, as recorded in the Australian Immunisation Registry
Timepoint [8] 416824 0
90 days after discharge
Secondary outcome [9] 416825 0
Self-reported utilisation of MedsCheck,

Pre and post participant surveys will be used to assess self-reported use.
Timepoint [9] 416825 0
90 days after discharge
Secondary outcome [10] 416853 0
Incremental costs and, if feasible, incremental cost-effectiveness ratio (ICER) in terms of readmissions avoided and Quality Adjusted Life Years gained, of the intervention compared to usual care.

Costs will include all aspects of the intervention, ascertained from project records, and health resources as a consequence of the intervention, ascertained from federal and state health record data and applying relevant cost weights where necessary (e.g. hospitalisation data). Costs of medicine management services that are not routinely captured in administrative data (e.g. dose administration aids) will be derived from self-reported use, using surveys specifically designed for this study. Health outcomes will based on hospital readmissions, which will be assessed using linked data from state hospital admitted patient care data collections, and QALYs, which will be calculated from self-reported health status using the EQ-5D-5L validated measure embedded within the study survey and applying the selected value set.
Timepoint [10] 416853 0
90 days after discharge
Secondary outcome [11] 416865 0
Number and type of pharmacist medication review findings and pharmacist recommendations in the intervention group

The outcome will be assessed using the medication review reports of consenting accredited pharmacists who conduct the reviews. Pharmacist review findings and recommendations will be categorised according to the Pharmaceutical Care Network Europe Classification for Drug related problems (The PCNE Classification V 9.1)
Timepoint [11] 416865 0
90 days after discharge
Secondary outcome [12] 416866 0
Number and type of pharmacist medication review recommendations enacted by GPs in the intervention group

The outcome will be assessed using the medication management plans and patient records of consenting GPs who develop the plans. Recommendations enacted by GPs will be categorised according to the Pharmaceutical Care Network Europe Classification for Drug related problems (The PCNE Classification V 9.1)
Timepoint [12] 416866 0
90 days after discharge
Secondary outcome [13] 416867 0
Participant reported experience and satisfaction with the medication review service in the intervention group.

The outcome will be assessed using data from a one-on-one 5-minute telephone survey developed specifically for this study. The survey will be administered in the same session as the other 90-day follow up surveys. Participant responses will not be audio recorded.
Timepoint [13] 416867 0
90 days after discharge
Secondary outcome [14] 417921 0
Change in the number of distinct medicines in individual medication lists that are categorised as anticholinergic in the intervention group compared to control/usual care.

Electronic medical record data (discharge summary letters) will be the source of medication lists at the time of discharge. Dispensing data linked from the Pharmaceutical Benefits Scheme/Repatriation Pharmaceutical Benefits Scheme (PBS/RPBS) and medication lists from GP records will be triangulated to derive the 90-day post-discharge medication list.. Medicines will be determined as distinct according to the Anatomic Therapeutic Chemical (ATC) Classification 5th level.

Anticholinergic medicines include but are not limited to medicines listed in 'Drugs with anticholinergic effects', Australian Medicines Handbook
Timepoint [14] 417921 0
90 days after discharge
Secondary outcome [15] 417922 0
Change in the number of distinct medicines in individual medication lists that are categorised as sedative in the intervention group compared to control/usual care.

Electronic medical record data (discharge summary letters) will be the source of medication lists at the time of discharge. Dispensing data linked from the Pharmaceutical Benefits Scheme/Repatriation Pharmaceutical Benefits Scheme (PBS/RPBS) and medication lists from GP records will be triangulated to derive the 90-day post-discharge medication list. Medicines will be determined as distinct according to the Anatomic Therapeutic Chemical (ATC) Classification 5th level.

Sedative medicines include but are limited to medicines listed in 'Drugs for Anxiety and sleep disorders', Australian Medicines Handbook.
Timepoint [15] 417922 0
90 days after discharge
Secondary outcome [16] 417923 0
Change in the number of distinct medicines in individual medication lists that are categorised as falls-risk increasing in the intervention group compared to control/usual care.

Electronic medical record data (discharge summary letters) will be the source of medication lists at the time of discharge. Dispensing data linked from the Pharmaceutical Benefits Scheme/Repatriation Pharmaceutical Benefits Scheme (PBS/RPBS) and medication lists from GP records will be triangulated to derive the 90-day post-discharge medication list. Medicines will be determined as distinct according to the Anatomic Therapeutic Chemical (ATC) Classification 5th level.

Falls-risk increasing medicines include but are not limited to medicines listed in the NSW TAG Medication-related Falls Risk Assessment Tool.
Timepoint [16] 417923 0
90 days after discharge
Secondary outcome [17] 417924 0
Self-reported utilisation of Diabetes MedsCheck

Pre and post participant surveys designed specifically for this study will be used to assess self-reported use.
Timepoint [17] 417924 0
90 days after discharge
Secondary outcome [18] 417925 0
Self-reported utilisation of dose administration aids

Pre and post participant surveys designed specifically for this study will be used to assess self-reported use.
Timepoint [18] 417925 0
90 days after discharge

Eligibility
Key inclusion criteria
Adult hospital in-patients who
1. Reside in the Primary Health Network of the hospital site.
2. Have a Medicare card
3 Have a nominated GP or nominated general practice in the Primary Health Network
4. Have a nominated community pharmacy in the Primary Health Network
5. Meet one or more of the following:
i.) Admission is due to a medication-related problem (as recorded in patient’s notes or identified during ward round)
ii.) Is taking 10 or more medicines (including PRN)
iii.) Has been started on 1 or more high-risk medicines during admission
iv.) Has had 4 or more changes made to medicines during admission
v.) Has had 1 or more change to a high-risk medicine or to a falls risk increasing medicine during admission
vi.) Is taking 2 or more falls risk increasing, anticholinergic or sedative medicines on discharge
vii.) Has difficulty managing medicines, as assessed by patient, GP, medical team or pharmacist, due to 1 or more of: (a) literacy or language; (b) dexterity or vision or frailty or mobility; (c) cognitive impairment or confusion or dementia; or (d) access to medicines (e.g., financial)

Definitions
High risk medicines include but are not limited to insulins, anticoagulants, oral hypoglycaemics, dual antiplatelet therapy, digoxin, opioids, oral cytotoxics, sedatives, hypnotics, anxiolytics, antipsychotics, anticholinergic medicines

Falls-risk increasing medicines include but are not limited to medicines listed in the NSW TAG Medication-related Falls Risk Assessment Tool.

Anticholinergic medicines include but are not limited to medicines listed in 'Drugs with anticholinergic effects', Australian Medicines Handbook

Sedative medicines include but are limited to medicines listed in 'Drugs for Anxiety and sleep disorders', Australian Medicines Handbook
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals will be excluded if they
1. are younger than 45 years of age.
2. are receiving active radiation therapy or chemotherapy for malignant conditions
3. have been admitted for planned dialysis
4. are in terminal phase of palliative care
5. are unable to attend Medication Management Review within the time frame
6. have previously been recruited to ASPIRE trial
7. are being transferred to a rehabilitation, private or other hospital

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The unit of randomisation is the 'cluster' not the recruited patient. There is one hospital and associated PHN per 'cluster'. The clusters will be randomised using computer software to one of four sequences in the stepped wedge design. Each cluster will start in the control phase and cross over to intervention conditions at different time points according to the randomisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This is a stepped wedge cluster randomised trial with four clusters across two states. Each cluster will have one hospital and associated Primary Healthcare Network (PHN) (centre).
The centres include:
• Royal North Shore Hospital – Northern Sydney PHN
• John Hunter Hospital – Hunter New England Central Coast
• Royal Brisbane and Women’s Hospital – Brisbane North PHN
• Broken Hill Hospital – Western NSW PHN
Patients will be recruited by research assistants (study pharmacists or study nurses) at the four hospitals over a 24-month period. Randomisation will occur at the cluster level not patient level. Trial centres will provide usual care (comparator treatment) until the time at which they have been randomised to start the intervention. The control phase will be 5, 9, 13 or 17 months in duration, depending on the random allocation of the centre. There will be a two-month transition period (lead-in) to the intervention phase. Patients will be blinded to the phase (control or intervention) in operation at the centre. Research assistants (study pharmacists or study nurses) will not be blinded. This means that while research assistants cannot allocate certain participants to intervention or control, they could apply selection bias during screening (e.g. select patients with certain characteristics for the intervention phase), a limitation of the design. Primary care practitioners (GPs and accredited pharmacists) will be recruited during the intervention phase by the Medication Safety Pharmacist in the PHN and will not be blinded.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size
The sample size was calculated for the primary outcome (unplanned all-cause readmissions at 90 days from the date of hospital discharge), following the methods of Hemming et al (1). A cluster size of 24 participants per one month time-period was calculated over 24 time periods for a cross-sectional stepped wedge design with 4 participating clusters, inclusive of a 2-month implementation (blanking) phase to detect a 13% absolute difference in proportion of patients readmitted within 90 days, with power of 0.8 and type I error of 0.05. The cluster size calculation assumes an intra-cluster correlation of 0.04 and cluster auto-correlation of 0.9 between time periods. Allowing for dropouts of participants within clusters (assumed to be 20% at 3-month follow-up), each cluster should recruit 528 patients, providing a total sample size of 2,112 patients (1,056 each per intervention and control phases).

The effect size is based on conservative estimates derived from Australian research (2,3) and other data. (4) We estimate that 35% of the study population will have an unplanned readmission within 90 days. Naunton et al (2003) found that 40% of people aged 75 years and over discharged from general medicine, aged care or rehabilitation wards had an unplanned readmission within 90 days. (2)
We estimate that intervention will reduce the proportion of people readmitted within 90 days by 13% compared with control/usual care. Freeman et al (2021) found that medication reviews after discharge reduced the proportion of people aged 60 years and older readmitted within 90 days by 17% (45% control versus 28% intervention; p=0.05) (3)

Analysis
This is a cross-sectional stepped-wedge design, with individual patients clustered within hospitals. All analyses will be conducted as per the intention-to-treat principle. For all questionnaire data, appropriate imputation methods will be applied to the missing data on any missing data at the item level. Patterns of missing data will be examined to determine if there is any potential bias. Complete case analysis will also be performed.

Generalised linear mixed models will be used to analyse both the primary and secondary outcome variables. Cluster will be modelled as a random effect, and time and treatment will be modelled as fixed effects. Patient-level covariates to be included in the analysis are gender, age (in years), the number of medicines (excluding PRN medicines) polypharmacy (number of medicines), comorbidities (Charlson Comorbidity Index), community vs. residential care, and rurality (The Modified Monash Model). The impact of the intervention on outcomes could increase or decrease over time. Therefore, we will also evaluate if the intervention effect will be maintained over time throughout the study, by including an interaction term (i.e. time since the intervention phase started, which is a continuous variable) as a sub-analysis. We will also perform the same analysis for a model involving a random time effect and/or a random intervention effect. Adjusted risk differences will be estimated from the model parameters.

The within-trial economic analysis from the Australian health system perspective will account for clustering and time to estimate the incremental costs and consequences of the intervention compared to usual care for the primary outcome measure. If feasible, incremental cost-effectiveness ratios (ICER) will be estimated, and plotted on a cost-effectiveness plane. Sensitivity analyses will be conducted to explore the robustness and validity of the cost-effectiveness results and any uncertainty around mean costs and outcome measures.

References
(1) Hemming K, Kasza J, Hooper R, Forbes A, Taljaard M. A tutorial on sample size calculation for multiple-period cluster randomized parallel, cross-over and stepped-wedge trials using the Shiny CRT Calculator. International Journal of Epidemiology. 2020;49(3):979-95.
(2) Naunton M, Peterson GM. Evaluation of Home-Based Follow-Up of High-Risk Elderly Patients Discharged from Hospital. Journal of Pharmacy Practice and Research. 2003;33(3):176-82.
(3) Freeman CR, Scott IA, Hemming K, Connelly LB, Kirkpatrick CM, Coombes I, et al. Reducing Medical Admissions and Presentations Into Hospital through Optimising Medicines (REMAIN HOME): a stepped wedge, cluster randomised controlled trial. The Medical journal of Australia. 2021;214(5):212-7.
(4) Lussier, M.E., H.J. Evans, E.A. Wright, and M.R. Gionfriddo, The impact of community pharmacist involvement on transitions of care: A systematic review and meta-analysis. Journal of the American Pharmacists Association, 2020. 60(1): p. 153-162.e5.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2023
Actual
Date of last participant enrolment
Anticipated
28/02/2025
Actual
Date of last data collection
Anticipated
29/05/2025
Actual
Sample size
Target
2112
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 23723 0
John Hunter Hospital - New Lambton
Recruitment hospital [2] 23724 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [3] 23725 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [4] 23726 0
Broken Hill Base Hospital - Broken Hill
Recruitment postcode(s) [1] 39161 0
2305 - New Lambton
Recruitment postcode(s) [2] 39162 0
2065 - St Leonards
Recruitment postcode(s) [3] 39163 0
4029 - Herston
Recruitment postcode(s) [4] 39164 0
2880 - Broken Hill

Funding & Sponsors
Funding source category [1] 312819 0
Government body
Name [1] 312819 0
Australian Government Department of Health and Aged Care (Medical Research Future Fund Grant)
Country [1] 312819 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Director, Post Award, Research Operations
Level 3, F23 Administration Building
Corner of Eastern Avenue and City Road,
The University of Sydney
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 314523 0
None
Name [1] 314523 0
Address [1] 314523 0
Country [1] 314523 0
Other collaborator category [1] 282508 0
University
Name [1] 282508 0
University of Newcastle
Address [1] 282508 0
Director of Research and Innovation Services
University of Newcastle
University Drive
CALLAGHAN
NSW 2308
Country [1] 282508 0
Australia
Other collaborator category [2] 282509 0
University
Name [2] 282509 0
Curtin University
Address [2] 282509 0
Director of Research Services and Systems
Curtin University
Building 100
Kent Street
BENTLEY
WA 6102
Country [2] 282509 0
Australia
Other collaborator category [3] 282510 0
University
Name [3] 282510 0
University of South Australia
Address [3] 282510 0
UniSA Research & Innovation Services
GPO Box 2471
ADELAIDE
SA 5000
Country [3] 282510 0
Australia
Other collaborator category [4] 282511 0
Government body
Name [4] 282511 0
Metro North Hospital and Health Service
Address [4] 282511 0
Executive Officer
Lwr Grd Floor
Royal Brisbane and Women's Hospital
Corner of Butterfield St and Bowen Bridge Road
HERSTON
QLD 4029
Country [4] 282511 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312099 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 312099 0
Ethics committee country [1] 312099 0
Australia
Date submitted for ethics approval [1] 312099 0
04/04/2022
Approval date [1] 312099 0
03/06/2022
Ethics approval number [1] 312099 0
2022/ETH00561

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

Contacts
Principal investigator
Name 123470 0
Prof Timothy F Chen
Address 123470 0
School of Pharmacy
Room 403, A16 Badham Building
Science Road
The University of Sydney
Camperdown
NSW 2006
Country 123470 0
Australia
Phone 123470 0
+61 2 9351 4440
Fax 123470 0
61 2 9351 4391
Email 123470 0
[email protected]
Contact person for public queries
Name 123471 0
Meredith Page
Address 123471 0
Study Coordinator, ASPIRE trial
School of Pharmacy
Room 402, A16 Badham Building
Science Road
The University of Sydney
Camperdown
NSW 2006
Country 123471 0
Australia
Phone 123471 0
+61286276976
Fax 123471 0
61 2 9351 4391
Email 123471 0
[email protected]
Contact person for scientific queries
Name 123472 0
Timothy F Chen
Address 123472 0
School of Pharmacy
Room 403, A16 Badham Building
Science Road
The University of Sydney
Camperdown
NSW 2006
Country 123472 0
Australia
Phone 123472 0
+61 2 9351 4440
Fax 123472 0
61 2 9351 4391
Email 123472 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
The trial is using linked data to measure outcomes. The data are de-identified but are potentially re-identifiable. To protect participant confidentiality, it is a requirement of data linkage organisations that IPD data provided to the research team is stored in a secure database with access restrictions.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17874Study protocol  [email protected]
17875Informed consent form  [email protected]
17876Ethical approval  [email protected]



Results publications and other study-related documents

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