Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000480583p
Ethics application status
Not yet submitted
Date submitted
11/03/2024
Date registered
19/04/2024
Date last updated
19/04/2024
Date data sharing statement initially provided
19/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
OPTimising MEDicine information handover after Discharge (OPTMED-D): a stepped wedge cluster randomised controlled trial
Scientific title
A stepped wedge cluster randomised controlled trial to evaluate the impact of a multifaceted intervention aimed at improving medicine information handover when patients are discharged from hospital back into the community
Secondary ID [1] 311695 0
None
Universal Trial Number (UTN)
Trial acronym
OPTMED-D
Linked study record

Health condition
Health condition(s) or problem(s) studied:
medication error 333175 0
transition from hospital 333176 0
Condition category
Condition code
Public Health 329865 329865 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A three-phased multi-method study will leverage existing transition of care strategies (e.g., discharge summaries) whilst introducing targeted innovations, namely a structured medicine handover process mediated by a digital solution, to improve medicine handover when patients are discharge from hospital. The trial registration record primary describes Phase 3 of the study.
Phase 1 is the Co-design of intervention with stakeholders and end-users over nine-month period. Key learnings from previous studies and workshops will be used to co-design and integrate the perspectives of hospital and primary care clinicians (GPs, community and credentialed pharmacists), consumers/patients and other relevant stakeholders.
Phase 2 is the development of the intervention over 12-month period. Building on the results of the Phase 1 workshops, this phase will develop infrastructure and resources to streamline medicine information handover from hospital to the community setting. This phase involves four primary tasks: developing handover guidelines, developing and pilot testing a digital solution,, training and customising the intervention, and defining the clusters for the Phase 3 intervention.
Phase 3 is the stepped wedge cluster randomised controlled trial (SW-CRT) over 12-month period. The SW-CRT design will be used to assess the effects of the multifaceted intervention over a 30-day follow-up period following hospital discharge.
The proposed intervention will commence in hospital, during discharge planning, with an active medicine handover from a hospital pharmacist navigator at each of the trial hospitals who will work with the patient to connect with the patient’s nominated community pharmacy and general practitioner (GP). The navigators will be paid through the project funding. They will liaise with the hospital pharmacists to identify patients at risk of potential medication-related harm post-discharge through the use of a validated tool (e.g. the PRIME tool) and criteria identified during Phases 1 and 2. The patient’s risk score will inform the handover to primary care clinicians: high risk will prompt a phone call in addition to secure emailing of the discharge medicine list whereas patients with a moderate risk will have secure email of their discharge medicine lists. We estimate the handover to take approx. 20 minutes, depending on how many medicines the patient is on, their risk score and the number of high-risk medicines.
Through established Medication Management Review (MMR) services, the patient’s medicines will be reconciled at the primary care level in the community pharmacy or in the patient’s home and follow-up actions communicated to the GP. Patients with a high risk will be recommended for a Home Medicine Review in the patient’s home with a credentialed pharmacist whereas medium risk will include a recommendation for a post-discharge MedsCheck in the patient’s nominated community pharmacy.
The pharmacist navigators will record which patients are part of the trial through a note in the electronic medical record system and will also keep a spreadsheet of which interventions were provided.
An innovative digital solution will prompt clinicians of actions being performed throughout the transition of care through asynchronous communication provided through a digital platform linking community pharmacists, GPs and patients. Phase 2 of the study will focus on the development of the digital solution. It is envisaged that the digital solution will integrate with existing prescribing and dispensing software and that GPs and community pharmacists will be prompted when there is updated information. We will use platform usage data to monitor how often it is used. An existing community pharmacy patient phone App will be modified for patients to enable them to make an appointment for a post-discharge MedsCheck with their community pharmacy before patients leave the hospital.
The intervention will be delivered at the level of the patient’s nominated community pharmacy and cluster randomisation will be used to allow for randomisation to occur at the level of the cluster (community pharmacy hub) instead of the participant. A one-month lead in phase is included, where the pharmacy cluster is not considered as being in the control or intervention phase, and the data collected during this time will not contribute to the final outcome analysis. Interventions will be implemented for new clusters monthly.
The SW-CRT design will enable the intervention to be provided to every community pharmacy cluster by the end of the study period, to measure possible underlying temporal trends (such as seasonal variation in admissions) and to prevent potential direct/indirect educational effects of the intervention carrying over to the control phase (which precludes a crossover design). Phase 3 will incorporate an evaluation of the impact of the intervention on key outcomes, a process evaluation and an economic evaluation.
Intervention code [1] 328167 0
Prevention
Intervention code [2] 328168 0
Early detection / Screening
Comparator / control treatment
Patients discharged from hospital receiving usual care namely receive a discharge medicine list, medicine counselling and the discharge medicine list is attached to the electronic discharge summary that is sent to the patient’s GP via secure web transfer.
Control group
Active

Outcomes
Primary outcome [1] 337641 0
Change in unplanned hospital readmissions at 30-days post-discharge due to medication related complications
Timepoint [1] 337641 0
30-days post-discharge from hospital
Secondary outcome [1] 432663 0
Changed medicine handover when patients are discharged from hospital to primary care.
Timepoint [1] 432663 0
Baseline and 3 months following the implementation of the multifaceted intervention.
Secondary outcome [2] 432664 0
Patients’ self-reported understanding of their medicines (i.e. how to take them).
Timepoint [2] 432664 0
Within 30 days post-discharge from hospital
Secondary outcome [3] 432665 0
Changes in health care usage
Timepoint [3] 432665 0
3 months after implementation of the multifaceted intervention.
Secondary outcome [4] 433674 0
Changed digital communication between hospitals, general practitioners and community pharmacists when patients are discharged from hospital to primary care.
Timepoint [4] 433674 0
3 months post implementation of the intervention.
Secondary outcome [5] 433675 0
Patients self-reported quality of life.
Timepoint [5] 433675 0
30 days following discharge from hospital

Eligibility
Key inclusion criteria
Patients at risk of hospital readmission due to potential medication-related harm
Hospital pharmacists, doctors and nurses involved in patients' discharge process.
Community pharmacists nominated by patients at their preferred community pharmacy.
GPs nominated by patients as their usual GPs.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who were admitted to hospital during the indexed admission due to a cancer diagnosis and are receiving chemotherapy,
Patients who were admitted to hospital during the indexed admission due to a mental health condition.
Patients who were admitted to hospital during the indexed admission due to kidney disease and who are on renal dialysis.
Individuals residing in nursing homes (Residential Aged Care Facilities)

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)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Stepped-wedge cluster randomisation
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In the primary analysis, overall differences in readmissions will be modelled using a mixed effects Poisson regression model with a random effect for cluster (pharmacy) and a fixed effect for each step to account for any secular trend. Secular trends may include seasonal variation in readmissions or changes in practice (outside of the project’s control). We also intend to allow for both levels of clustering at the analysis stage, i.e., we will allow for both clustering by hospital and clustering by pharmacy (the unit of randomisation). This will be achieved by including both a random effect for community pharmacy hub and a random effect for hospital. Robust standard errors will be used to allow for the misspecification of the error structure when using the Poisson model to model binary events. We will report treatment effects both on the relative and absolute scale. We will also report estimates of intra cluster correlations.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2025
Actual
Date of last participant enrolment
Anticipated
30/09/2026
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
2200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 26248 0
Gold Coast University Hospital - Southport
Recruitment hospital [2] 26249 0
Robina Hospital - Robina
Recruitment hospital [3] 26250 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [4] 26251 0
Queen Elizabeth II Jubilee Hospital - Coopers Plains
Recruitment hospital [5] 26252 0
Logan Hospital - Meadowbrook
Recruitment hospital [6] 26253 0
Redland Hospital - Cleveland
Recruitment hospital [7] 26254 0
Beaudesert Hospital - Beaudesert
Recruitment postcode(s) [1] 42219 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 42220 0
4108 - Coopers Plains
Recruitment postcode(s) [3] 42221 0
4131 - Meadowbrook
Recruitment postcode(s) [4] 42222 0
4163 - Cleveland
Recruitment postcode(s) [5] 42217 0
4215 - Southport
Recruitment postcode(s) [6] 42218 0
4226 - Robina
Recruitment postcode(s) [7] 42223 0
4285 - Beaudesert

Funding & Sponsors
Funding source category [1] 316025 0
Government body
Name [1] 316025 0
Australian Government Department of Health and Aged Care: Medical Research Future Fund
Country [1] 316025 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 318177 0
University
Name [1] 318177 0
Monash University
Address [1] 318177 0
Country [1] 318177 0
Australia
Secondary sponsor category [2] 318191 0
University
Name [2] 318191 0
Curtin University
Address [2] 318191 0
Country [2] 318191 0
Australia
Secondary sponsor category [3] 318192 0
University
Name [3] 318192 0
University of Sydney
Address [3] 318192 0
Country [3] 318192 0
Australia
Secondary sponsor category [4] 318193 0
University
Name [4] 318193 0
Bond University
Address [4] 318193 0
Country [4] 318193 0
Australia
Secondary sponsor category [5] 318194 0
Government body
Name [5] 318194 0
Gold Coast Hospital and Health Service
Address [5] 318194 0
Country [5] 318194 0
Australia
Secondary sponsor category [6] 318195 0
Government body
Name [6] 318195 0
Metro South Hospital and Health Service
Address [6] 318195 0
Country [6] 318195 0
Australia
Secondary sponsor category [7] 318196 0
Other Collaborative groups
Name [7] 318196 0
Pharmaceutical Society of Australia Limited
Address [7] 318196 0
Country [7] 318196 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 314848 0
Gold Coast Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 314848 0
https://www.goldcoast.health.qld.gov.au/research/researchers/ethics/human-research-ethics-committee
Ethics committee country [1] 314848 0
Australia
Date submitted for ethics approval [1] 314848 0
28/02/2025
Approval date [1] 314848 0
Ethics approval number [1] 314848 0

Summary
Brief summary
TThe OPTMED-D study aims to improve medicine handover and digital communication between hospitals, general practitioners (GPs) and community pharmacists when patients are discharged from hospital to primary care. It also aims to increase uptake of post-discharge medication management reviews by community and credentialed pharmacists. We hypothesise that the multifaceted intervention will reduce 30-day hospital readmissions due to medication related complications, improve patients’ self-reported understanding of their medicines (i.e. how to take them) and quality of life, and lead to a reduction in health care usage.
This study will leverage existing transition of care strategies (e.g., discharge summaries) whilst introducing targeted innovations, namely a structured medicine handover process mediated by a digital solution. Stakeholders and end-users will be engaged to co-design a multifaceted intervention that will follow the patient’s transition of care, thus placing the patient at the centre of care. A three-phased, multi-method study design will be followed that is underpinned by the Knowledge-to-Action Framework, with Phase 3 only described in this registration:
Phase 1: Co-design of intervention with stakeholders and end-users over nine-month period is underpinned by the Knowledge-to-Action Framework:
Phase 2: Development of the intervention over 12-month period
Phase 3: Stepped wedge cluster randomised controlled trial (SW-CRT) over 12-month period
Trial website
https://pharmacy.uq.edu.au/research/optmed-d
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132914 0
A/Prof Laetitia Hattingh
Address 132914 0
Gold Coast Hospital and Health Service, 1 Hospital Blvd, Southport, Gold Coast, Queensland 4215
Country 132914 0
Australia
Phone 132914 0
+61409515715
Fax 132914 0
Email 132914 0
laetitia.hattingh@health.qld.gov.au
Contact person for public queries
Name 132915 0
Laetitia Hattingh
Address 132915 0
Gold Coast Hospital and Health Service, 1 Hospital Blvd, Southport, Gold Coast, Queensland 4215
Country 132915 0
Australia
Phone 132915 0
+61409515715
Fax 132915 0
Email 132915 0
laetitia.hattingh@health.qld.gov.au
Contact person for scientific queries
Name 132916 0
Laetitia Hattingh
Address 132916 0
Gold Coast Hospital and Health Service, 1 Hospital Blvd, Southport, Gold Coast, Queensland 4215
Country 132916 0
Australia
Phone 132916 0
+61409515715
Fax 132916 0
Email 132916 0
laetitia.hattingh@health.qld.gov.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?

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.