Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000727640p
Ethics application status
Submitted, not yet approved
Date submitted
19/06/2023
Date registered
5/07/2023
Date last updated
5/07/2023
Date data sharing statement initially provided
5/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Timely post-discharge medication reviews to Improve Continuity – the Transitions Of Care stewardship (TIC TOC) study in rural and regional Australia
Scientific title
Timely post-discharge medication reviews to Improve Continuity – Effect of the Transitions Of Care stewardship (TIC TOC) study on medication-related readmission or emergency department visit among discharged patients in rural and regional Australia.
Secondary ID [1] 309552 0
MRFMMIP000023
Universal Trial Number (UTN)
Trial acronym
TIC TOC Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Disease 329868 0
medication misadventure 330490 0
Condition category
Condition code
Public Health 326776 326776 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is based on the Consolidated Framework of Implementation Research as it has been used extensively to implement health services. The intervention will include virtual Transition of Care Stewardship pharmacists to ensure patients receive discharge counselling, discharge medical reconciliation, and communicate directly with primary care providers (GPs, practice nurses, community pharmacies and accredited pharmacists). They will provide accurate and timely medication handover to facilitate a timely post-discharge medication review. Patients’ autonomy is central to the intervention, as they can choose whether they prefer a face-to-face HMR or a virtual HMR. HMR will our with 30 days of discharge and then follow ups at 90 and 180 days.
In the study, the Research Assistant will be responsible for providing information to potential participants. Once consent is obtained, the participants will be randomly assigned to one of two groups: Usual Care Group: Participants in this group will continue to receive the usual care provided by the hospital at discharge. They will follow the standard procedures and protocols without any additional intervention. Intervention Group: Participants in this group will also go through the usual care process but will additionally have access to the TICTOC service. The TICTOC service will provide them with additional support or interventions beyond the usual care, tailored to their needs.
As part of the study, regardless of the group allocation, participants will be contacted by a researcher for a brief interview either just before discharge from the hospital or once they return home. The purpose of this interview is to gather information about their hospital stay, medications, and how to effectively manage them. The interviews will be conducted by researchers who have received training in qualitative research methods, using telephone or videoconferencing as the mode of communication.
In the intervention group, just before discharge, a pharmacist will have a brief conversation with the participants using the hospital computer system to arrange a Home Medicine Review (HMR). The HMR involves a consultation with a pharmacist that typically lasts between 30 to 60 minutes. Ideally, this consultation will take place at the participant's home. However, if necessary, it can also be conducted virtually or at an Aboriginal Medical Service.
Following the consultation, the pharmacist will provide a report to the participant's medical service or general practitioner, and the participant will receive a summary of the consultation. The goal of the HMR is to assist the participants and their local health practitioners in effectively managing their care and medications. Researchers will compare the patient's medication list before and after the review to identify any discrepancies or changes in medication adherence. Follow-up assessments will be conducted through patient interviews or follow-up visits to evaluate their adherence to the medication regimen.
Patients will also receive lay summaries of the HMR reports to empower them to take responsibility for their medication management. The data collection phase will span over a period of 6 months. This means that participants will be followed up and their data will be collected during this time frame to evaluate the effectiveness and outcomes of the intervention. Furthermore, GPs, and accredited and community pharmacists’ collaboration will be encouraged through case conferences to discuss complex patients (remunerated for their time). The intervention will also be adapted to local needs. Pharmacists caring for Aboriginal and Torres Strait Islander peoples will complete Cultural Responsiveness Training by the Indigenous Allied Health Australia at least one month prior to the intervention administered. Furthermore, this study will explore the implementation aspects of the intervention.

The SHPA (Society of Hospital Pharmacists of Australia) pathway implemented in this study has the primary objective of preserving patients' existing support systems by involving their regular General Practitioner (GP). The intention is to collaborate with the GP to ensure continuity of care. However, in cases where the GP is unavailable or an urgent Home Medicine Review (HMR) referral cannot be facilitated through the GP, the study allows for a hospital-based medical specialist to make the referral instead. In such cases, the GP will be informed about the review and provided with a copy of the pharmacist's report, ensuring effective communication and coordination of care.
The SHPA protocols used in this study encompass various aspects including screening and risk stratification, information sharing, home visits, follow-ups, and delineation of responsibilities for each clinician involved. These protocols serve as the foundation for the study, providing a standardized framework to guide the implementation and execution of the intervention. By incorporating these protocols, the study aims to ensure consistent and comprehensive management of participants' care, promoting collaboration among healthcare professionals and optimizing patient outcomes.
Intervention code [1] 325992 0
Prevention
Comparator / control treatment
Control - Usual Care
Usual care will include informing the patient's clinical inpatient team that they are at high-risk of medication misadventure, and they may benefit from a HMR. Usual pathways to communicate the need for a HMR to the patient's regular GP will be used.
Control group
Active

Outcomes
Primary outcome [1] 334628 0
Medication-related readmission or emergency department visit using patient medical records, linked data, and expert panel
Timepoint [1] 334628 0
30 days post-hospital discharge
Secondary outcome [1] 423110 0
Medication-related readmission and ED visit at 90 days using patient medical records, linked data, and expert panel
Timepoint [1] 423110 0
90 days post-hospital discharge
Secondary outcome [2] 423111 0
Medication-related readmission and ED visit at 180 days using patient medical records, linked data, and expert panel
Timepoint [2] 423111 0
180 days post-hospital discharge
Secondary outcome [3] 423133 0
Cost-effectiveness of the TIC TOC intervention compared to the usual care.
The analysis will consist of three main parts. First, primary outcomes for each treatment arm are calculated (TIC TOC intervention versus best usual care). Second, all costs to implement the intervention and usual care throughout the trial are accounted. Costs might include staff time, training, and any additional resources required to deliver and engage stakeholders. For each patient, we will collect information related to their health service use within each care cycle. These data be either captured by the hospitals' electronic record systems or follow-up enquiries (see description below). Costs will be valued based on government charges using publicly available data and reported in Australian dollars. Third, the cost-effectiveness analysis will be modelled using techniques appropriate for RCT and the non-normal nature of both the cost and outcome variables (e.g., a generalised linear model with robust standard errors).
Following the base case analysis, univariate and probabilistic sensitivity analyses will be conducted around key parameters likely to influence the cost and effectiveness estimates, including variability in the sampling, trial sites, and patient populations by risk factors.
Timepoint [3] 423133 0
30 days post-hospital discharge
Secondary outcome [4] 423134 0
Patient's quality of life using EQ5D-5L
Timepoint [4] 423134 0
30 days post-hospital discharge
Secondary outcome [5] 423174 0
Patient's quality of life using EQ5D-5L
Timepoint [5] 423174 0
90 days post-hospital discharge
Secondary outcome [6] 423175 0
Patient's quality of life using EQ5D-5L
Timepoint [6] 423175 0
180 days post-hospital discharge
Secondary outcome [7] 423504 0
Patient Experiences of TOCS Service using semi-structured interviews.
Timepoint [7] 423504 0
Before and 30 days after the TOCS Service is provided..

Eligibility
Key inclusion criteria
Eligible patients must be aged greater than or equal to 18 years, admitted under a medical specialty, discharged to a domiciliary setting, have a GP, have a Medicare card, and be at risk of readmission (defined as high-risk according to the PHarmacie-R risk algorithm).
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include unmanaged substance use disorder or mental health condition, active palliative care, homelessness, admission for planned dialysis, unsafe home environment (domestic violence or aggression), and planning to change residence in six months, or previously recruited.

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)
One study investigator will contact the central randomization service by telephone each time a patient is to be randomized to allow allocation concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised in a 1:1 ratio in permuted blocks of 2 and 4 to: (1) intervention; or (2) usual care. Randomisation will be conducted using a centralised service to ensure allocation concealment. Randomisation will be stratified by states to allow for random and systematic differences in acute care practices between states.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Usual care will include informing the patient's clinical inpatient team that they are at high-risk of medication misadventure, and they may benefit from a HMR. Usual pathways to communicate the need for a HMR to the patient's regular GP will be used.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
All analyses will be performed on an intent-to-treat basis. Standard summary statistics will be reported for all variables. Comparisons between the intervention and usual care groups will be made using t-tests, Mann-Whitney tests, or chi-squared tests, depending on the variable of interest. The primary outcome (composite of a first unplanned hospitalization or ED presentation within 30 days of hospital discharge) will be assessed using a logistic regression analysis with stratification by the site. Subsequently, potential confounders such as age, comorbidities, number of medicines, and socioeconomic status will be considered. A competing risk analysis will be performed (death as the competing risk) should there be a considerable number of deaths within 30 days of hospital discharge Sub-group analyses will also be carried out between sites and with Aboriginal and Torres Strait Islander patients. Secondary outcomes will be analyzed similarly to the primary outcome. Appropriate regressions will be used to compare the two groups' unplanned bed days and medicine counts. Sensitivity analyses using a per-protocol approach will also be performed. A two-sided p-value greater than or equal to 0.05 will be considered statistically significant.
The analysis will consist of three main parts. First, primary outcomes for each treatment arm are calculated (TIC TOC intervention versus best usual care). Second, all costs to implement the intervention and usual care throughout the trial are accounted. Costs might include staff time, training, and any additional resources required to deliver and engage stakeholders. For each patient, we will collect information related to their health service use within each care cycle. These data be either captured by the hospitals' electronic record systems or follow-up inquiries (see description below). Costs will be valued based on government charges using publicly available data and reported in Australian dollars. Third, the cost-effectiveness analysis will be modelled using techniques appropriate for RCT and the non-normal nature of both the cost and outcome variables (e.g., a generalized linear model with robust standard errors). Following the base case analysis, univariate and probabilistic sensitivity analyses will be conducted around key parameters likely to influence the cost and effectiveness estimates, including variability in the sampling, trial sites, and patient populations by risk factors. Following the statistical analysis of EQ5D-5L scores, comparing the TIC TOC intervention and best usual care, we will convert the scores into utility. The utility score will then be used to conduct a cost-utility analysis as a secondary economic analysis for the trial. This analysis follows the same procedure and uses similar econometrics techniques as the (primary) cost-effectiveness analysis described above. Its outcome will offer additional evidence regarding the cost-effectiveness nature of the intervention.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2023
Actual
Date of last participant enrolment
Anticipated
6/04/2026
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
922
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 313744 0
University
Name [1] 313744 0
The University of Sydney
Country [1] 313744 0
Australia
Primary sponsor type
Government body
Name
The Commonwealth of Australia represented by the Department of Health and Aged Care (Funding Agreement managed by The Department of Industry, Science and Resources)
Address
Department of Health and Aged Care
GPO Box 9848
Canberra ACT 2601
Australia
Country
Australia
Secondary sponsor category [1] 315561 0
University
Name [1] 315561 0
The University of Sydney
Address [1] 315561 0
Camperdown NSW 2006
Country [1] 315561 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 312916 0
Greater Western New South Wales Local Health District Committee
Ethics committee address [1] 312916 0
PO Box 4061,
Dubbo NSW 2830
Ethics committee country [1] 312916 0
Australia
Date submitted for ethics approval [1] 312916 0
15/05/2023
Approval date [1] 312916 0
Ethics approval number [1] 312916 0
Ethics committee name [2] 313242 0
Aboriginal Health and Medical Council Ethics Committee of NSWResearch
Ethics committee address [2] 313242 0
Gadigal Country
Level 4, 280 Pitt Street,
Sydney NSW 2000
Ethics committee country [2] 313242 0
Australia
Date submitted for ethics approval [2] 313242 0
27/06/2023
Approval date [2] 313242 0
Ethics approval number [2] 313242 0

Summary
Brief summary
After hospital discharge, over 90% of Australians have at least one medication-related problem. Transitions of care are a period when the risk of medication errors and adverse events is high. Improving medication safety at these transitions is one of three flagship areas of the World Health Organisation Global Patient Safety Challenge: Medication Without Harm. In Australia, an estimated 250,000 hospital admissions annually are medication-related, costing $1.4 billion per year. In particular, rural and remote Australians are up to 2.4 times more likely to have a preventable hospitalisation than non-rural Australians. Furthermore, Aboriginal and Torres Strait Islander people, who often live in rural and regional areas, are three times as likely to have a preventable hospitalisation than non-indigenous Australians. Medication-related hospital readmissions in rural and regional Australian hospitals have been shown to be due to inappropriate/suboptimal pharmacological therapy at discharge in 62% of cases and inadequate communication/monitoring in 41% of cases. Due to pharmacists’ expertise in medication management, two systematic reviews have shown that pharmacy-led transitions of care services can successfully reduce hospital readmissions. These systematic reviews showed that the combination of (i) targeting specific patient populations and (ii) utilisation of an effective transition of care stewardship (TOCS) intervention reduced 30-day readmissions with the meta-analysis showing a 32% reduction in odds for readmission. These TOCS interventions included discharge counselling, discharge medication reconciliation and medication reviews. In Australia, the Commonwealth funds pharmacist led HMRs, which have been shown to reduce medication errors and unplanned hospital readmissions if provided promptly. When high-risk patients receive a timely post-discharge HMR, the rates of unplanned readmission reduce (45% vs 28%, P<0.05). Despite this, strategies (i) and (ii) described above are not routinely implemented and the provision of HMRs to high-risk patients after discharge is unacceptably low at 1-2%.
A recent study by our team (2022) explored the reasons for low uptake of post-discharge HMRs. We found many implementation issues that are reflected in the Consolidated Framework for Implementation Research (CFIR). These include the (i) outer setting (GPs not remunerated for participating in hospital-initiated medication reviews, HMR numbers capped for pharmacists, pharmacists not funded for case conferences), (ii) inner setting (limited staffing for transitions of care), (iii) processes (lack of streamlined pathways, no risk tools used) and (iv) individuals involved (poor prescriber awareness). To address these concerns, our team developed the SHPA Hospital-initiated Medication Review protocols to support hospital clinicians to facilitate timely post-discharge medication reviews.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126322 0
Dr Jonathan Penm
Address 126322 0
N371, Pharmacy, and Bank Building A15
The University of Sydney, NSW, 2006
Country 126322 0
Australia
Phone 126322 0
+61 2 8627 5806
Fax 126322 0
+61 2 9351 4391
Email 126322 0
jonathan.penm@sydney.edu.au
Contact person for public queries
Name 126323 0
Dr Jonathan Penm
Address 126323 0
N371, Pharmacy, and Bank Building A15
The University of Sydney, NSW, 2006
Country 126323 0
Australia
Phone 126323 0
+61 2 8627 5806
Fax 126323 0
Email 126323 0
jonathan.penm@sydney.edu.au
Contact person for scientific queries
Name 126324 0
Dr Jonathan Penm
Address 126324 0
N371, Pharmacy, and Bank Building A15
The University of Sydney, NSW, 2006
Country 126324 0
Australia
Phone 126324 0
+61 2 8627 5806
Fax 126324 0
+61 2 9351 4391
Email 126324 0
jonathan.penm@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19040Study protocolStudy Protocol   385816-(Uploaded-18-06-2023-21-57-08)-Study-related document.docx



Results publications and other study-related documents

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