Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000493448
Ethics application status
Approved
Date submitted
5/05/2025
Date registered
21/05/2025
Date last updated
21/05/2025
Date data sharing statement initially provided
21/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating a Collaborative Approach for Reducing harm and optimising Medication outcomes through partnered prescribing: The CARe-Med study.
Scientific title
Evaluating a Collaborative Approach for Reducing harm and optimising Medication outcomes through partnered prescribing: The CARe-Med study.
Secondary ID [1] 314363 0
2031745
Universal Trial Number (UTN)
U1111-1322-2588
Trial acronym
CARe-Med
Linked study record

Health condition
Health condition(s) or problem(s) studied:
medication-related harm 337359 0
Condition category
Condition code
Public Health 333745 333745 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be Partnered Pharmacist Medication Prescribing (also known as “PPMP”).

Partnered Pharmacist Medication Prescribing refers to the prescribing for administration of patient medicines by a credentialled pharmacist, after patient engagement and a documented clinical conversation with a medical officer responsible for the patient’s care. In the CARe-Med study Partnered Pharmacist Medication Prescribing may occur on admission, during the inpatient stay and on discharge.

The intervention will be performed by credentialled partnered prescribing pharmacists and will encompass partnered prescribing on admission, partnered prescribing during the inpatient stay, and partnered prescribing on discharge, as described in detail below. Intervention pharmacists will be employed to work the standard 37.5 h per week, this includes five 7.5 h shifts on Monday-Friday each week, typically between the hours of 8am-5pm, with precise shift start and finish times dependent on workflows within the clinical unit. The intervention pharmacist will not provide a service after hours or over the weekend. At times, the appointed intervention pharmacist may require sick leave and/or personal leave. For periods of planned leave extending beyond 5 consecutive days cover will be provided by an alternative suitably trained pharmacist where available. The intervention will primarily be performed by the intervention pharmacist deployed as part of this trial, however supplementary partnered prescribing may also be performed by the existing usual care pharmacist during the intervention period, if they are appropriately credentialled to prescribe.

The intervention will be performed in accordance with the the local approved frameworks and procedures for Partnered Pharmacist Medication Prescribing (PPMP) within SA Health and Metro South Health.

The intervention will be implemented in addition to usual care. This means patients who receive the partnered pharmacist prescribing intervention may also have medicines prescribed by doctors.

All pharmacists delivering the intervention will be employed by the appropriate health service (SA Health or Metro South Health) and will be trained and credentialled to undertake collaborative partnered pharmacist prescribing in line with the locally approved credentialing procedures. These processes have been through multidisciplinary consultation and have been endorsed through formal governance processes within each health service. In line with local credentialling processes, employers will be responsible for ensuring all pharmacists delivering this model of care remain appropriately credentialled throughout the intervention period. Not fixed timing of the credentialling process (which includes training) is set relative to the CARe-Med study, if a pharmacists credentials remain current per the local requirements, they are sufficiently qualified to deliver the partnered pharmacist medication prescribing intervention.

Partnered pharmacist prescribing for inpatient administration:
On admission, the partnered prescribing pharmacist (or another pharmacy team member) conducts a best possible medication history. The partnered prescribing pharmacist then discusses the medication-related treatment goals and preferences with the patient and/or their family/carer as clinically appropriate. The conversation with the patient and/or family/carers is anticipated to take up to 15 minutes, although the duration required will be dependent the complexity of the medication regimen and other patient-specific factors. Next the pharmacist reviews the medication history in the context of the patient’s current admission, preferences and goals and creates a shared medication management plan, which is discussed with the patient and the treating medical officer, documented in the progress notes and co-signed by the treating medical officer and the partnered prescribing pharmacist. The plan may include medications the patient was taking prior to admission (with or without modifications) and/or new medications, depending on the clinical need. A copy of documentation of this medication plan and/or goals discussed will not routinely be provided to the patient, in line with local practice for documenting inpatient clinical care decisions. Deprescribing, as part of good prescribing process, may occur when determining the medication plan, with partnered prescribing pharmacists encouraged to consider the CEASE framework in their medication assessment. Finally, the partnered prescribing pharmacist prescribes the patients medications as per the co-signed medication management plan in the electronic medical record and communicates with the nursing staff regarding the prescribed medicines as necessary. This process may be repeated from the point of discussing, documenting and co-signing a medication management plan onwards at any time during the inpatient stay, for example, during ward rounds. The initial partnered pharmacist medication prescribing on admission will occur as soon as practical after admission, ideally within 12 hours. If partnered prescribing is not feasible in a timely manner independent medical prescribing will take place, as the intervention is in addition to usual care. Electronic medical record data will be reviewed regularly during the transition and intervention periods to monitor adherence to this component of the intervention.

Partnered pharmacist prescribing on discharge:
In the CARe-Med intervention, partnered pharmacist medication prescribing may also occur during the discharge process. In this situation, the pharmacist reviews the patients medication regimen in the context of the patient’s current admission, preferences and goals and creates a shared medication management plan for discharge. The conversation with the patient and/or their family/carer(s) is anticipated to take up to 15 minutes, although the duration required will be dependent the complexity of the medication regimen and other patient specific factors. The medication management plan for discharge is discussed with the medical team, documented in the progress notes and co-signed by the treating medical officer and the partnered prescribing pharmacist. As for inpatient prescribing, the plan may include medications the patient was taking prior to admission (with or without modifications) and/or new medications, depending on the clinical need. The partnered prescribing pharmacist prescribes the patients medications as per the co-signed medication management plan to create a discharge prescription using the electronic medical record. The partnered prescribing pharmacist then liaises with the usual care pharmacist and/or other staff to have the prescription dispensed. This prescription will not be eligible for subsidy via the Pharmaceutical Benefits Scheme and thus to prevent unnecessary financial burden on the patient, the prescription must be dispensed at the subsided rate by the hospital dispensary prior to discharge. The partnered prescribing pharmacist then includes a summary of the medication management plan in the transition of care communication documents, in line with local discharge processes. The partnered prescribing pharmacist then includes a summary of the medication management plan in the transition of care communication documents, in line with local discharge processes. Typically, a copy of the relevant transition of care documents (which will include a summary of the medication managment plan) is provided to the patient on discharge.
If the clinical unit is within a hospital that does not have an on-site dispensary, or for sites where local authorisation for prescribing on discharge cannot be obtained, the pharmacist will complete all steps above to create a collaborative medication plan for discharge and will liaise with the medical team to ensure the discharge prescription is prepared accordingly. Electronic medical record data will be reviewed regularly during the transition and intervention periods to monitor adherence to this component of the intervention.

In this stepped-wedge trial the duration of each "step" is one month, i.e. the intervention will be implemented at each subsequent site after a one month interval.
Intervention code [1] 330982 0
Prevention
Comparator / control treatment
The comparator group will be usual care, which involves independent medical prescribing and non-prescribing clinical pharmacy services.

Independent medical prescribing in the hospital setting refers to doctors autonomously assessing patients, making prescribing decisions and charting medications/writing prescriptions. In this process doctors may receive advice from a non-prescribing pharmacist, however it differs from partnered pharmacist medication prescribing as there is no requirement for the doctor and pharmacist to come to a collaborative agreement and it is the doctor, rather than the pharmacist who charts the medication or writes the prescription. Non-prescribing clinical pharmacy services typically include but are not limited to medication history taking, medication reconciliation, medication chart review, review of discharge prescriptions, communication about medicines with external providers on discharge, provision of advice to nursing and medical staff, provision of medicines counselling for patients and/or family/carer(s). The non-prescribing clinical pharmacy services may vary according to the needs of the participating clinical unit.
Control group
Active

Outcomes
Primary outcome [1] 341329 0
The primary outcome will be the proportion of admissions involving one or more medication-related harm events In this trial, medication-related harm events are defined as any harm events experienced by a patient as a result of exposure to, or omission of, a medication. This includes harm from the medicine itself and harm resulting from errors or system failures associated with the prescribing, dispensing, distribution or administration of the medicines. This definition is adapted from the SA Health Policy: Preventing Adverse Drug Events.
Timepoint [1] 341329 0
The primary outcome will be assessed at the conclusion of the trial.
Secondary outcome [1] 447145 0
Number of medication-related harm events per 100 patient days
Timepoint [1] 447145 0
This outcome will be assessed at the conclusion of the trial.
Secondary outcome [2] 447146 0
Proportion of admissions with one or more medication prescribing discrepancies at 24 h post admission
Timepoint [2] 447146 0
This outcome will be assessed at the conclusion of the trial.
Secondary outcome [3] 447147 0
Median length of hospital stay in days
Timepoint [3] 447147 0
This outcome will be assessed at the conclusion of the trial.
Secondary outcome [4] 447148 0
Number of hospital acquired complications (Medication complications) as defined by the Australian Commission on Safety and Quality in Health Care, per 100 patient days. Examples of medication-related hospital acquired complications include: Drug related respiratory complications/depression, haemorrhagic disorder due to circulating anticoagulants and serious alteration to conscious state due to psychotropic medication.
Timepoint [4] 447148 0
This outcome will be assessed at the conclusion of the trial.
Secondary outcome [5] 447149 0
Number of rapid response team calls per 100 patient days
Timepoint [5] 447149 0
The outcome will be assessed at the conclusion of the trial.
Secondary outcome [6] 447150 0
Proportion of patients requiring transfer to an intensive care unit
Timepoint [6] 447150 0
This outcome will be assessed at the conclusion of the trial.
Secondary outcome [7] 447151 0
In-hospital mortality
Timepoint [7] 447151 0
This outcome will be assessed at the conclusion of the trial.
Secondary outcome [8] 447152 0
Readmission rate to the same local health network within 30 days post discharge
Timepoint [8] 447152 0
This outcome will be assessed 30 days after the conclusion of the trial.
Secondary outcome [9] 447575 0
Proportion of admissions involving one or more 'verified' medication-related harm events
Timepoint [9] 447575 0
This outcome will be assessed at the conclusion of the trial.

Eligibility
Key inclusion criteria
This study will be conducted in public inpatient hospital wards using electronic medical records at metropolitan and regional sites within SA Health (SA) and Metro South Health (QLD). The predefined number of clinical units (n=8) meeting the inclusion criteria below have been identified, and all patients receiving care under that clinical unit will be eligible to receive the intervention.

Within this protocol, a clinical unit refers to a specific hospital department where patients receive care for particular medical conditions or procedures. These units are organised by specialty (e.g., general medicine, cardiology) and are staffed by healthcare professionals with expertise in those areas. Each unit is equipped to meet the specific needs of its patients, offering tailored treatments, monitoring, and interventions. Clinical units may be based in a particular area or ward within the hospital, but they can also operate across multiple locations. Patients outside of the clinical unit’s designated physical space may still receive care under that unit, as indicated on their bed card.
Five clinical units will be recruited from within SA Health (four metropolitan and one regional) and three clinical units will be recruited from Metro South Health (two metropolitan and one regional). More than one clinical unit may be recruited from within the same hospital. Where possible units will be recruited from physically distinct wards to minimise the risk of confounding.

Clinical units will be eligible for inclusion if they meet the following criteria:
1. Exist within a public hospital to deliver an inpatient service within SA Health or Metro South Health
2. Use electronic medical records, including electronic prescribing processes
3. Have an existing embedded clinical pharmacy service that will continue throughout the trial period
4. Have a baseline average length of stay equal to or greater than 48 hours
5. Have not had a pharmacist-medical officer collaborative prescribing model of care implemented within the unit within the 6 months immediately prior to the trial start date or during the baseline data collection period (note that units with medical officers or pharmacists rotating in from other units which did have a collaborative prescribing model of care will still be eligible)
6. Typically admit a high proportion (average >60%) of patients who are:
a. >65 years of age at time of admission
b. experiencing at least one 'disease of aging' at/during admission, defined to include cardiovascular disease, type 2 diabetes, chronic obstructive pulmonary disease, neurodegenerative diseases, cancer, arthritis, osteoporosis, hearing loss and/or age-related macular degeneration
c. prescribed at least one regular medication prior to admission
7. Typically admit two or more new-to-hospital patients who can receive the partnered prescribing intervention per day, Mon-Fri, 8am-5pm (i.e. excluding inter-hospital and intra-hospital transfers into the unit)
8. Have a medical team who consent to participate and willing to undertake the required training to implement the intervention

While all patients admitted to the participating clinical units will be eligible to receive the intervention, it is not expected that all patients will receive the intervention. Which patients receive the intervention will be driven by clinician capacity, clinical need and will be at the discretion of the clinical staff (medical team, intervention pharmacist).

All patients admitted to a participating clinical unit during the control or intervention period will be eligible to be included in the primary analysis. Patients may be admitted to a clinical unit participating in the trial more than once during each or both of the control and intervention periods. There is also potential for participants to be admitted more than one participating clinical unit during the trial.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clinical units will be ineligible for inclusion if they meet the following criteria:
1. Involve workflows that are likely to prohibit implementation of the collaborative prescribing intervention
2. Expect significant foreseeable changes to the unit structure or processes during the trial period that could confound the trial results

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)
This is a pragmatic stepped-wedge cluster randomised controlled trial.

Given the small number of sites involved in the trial, blocked randomisation was used to allocate sites to eight possible intervention dates. Although blocked designs typically aim to balance two conditions (e.g., intervention vs. control), this was not applicable as all sites were assigned to receive the intervention. Instead, three blocks of unequal sizes – 3, 3, and 2 – were constructed. This configuration was chosen to ensure representation from each stratum across time, while avoiding the fixed or repetitive patterns that could result from using four blocks of two.
Each block of three included two sites from stratum 1 and one from stratum 2, while the block of two included one site from each stratum, ensuring temporal representation across strata. Sites were assigned to blocks using simple random sampling without replacement. The first three start dates (Start Dates 1-3) were then randomly allocated to sites within block 1, the next three dates (Start Dates 4-6) to block 2, and the final two start dates (Start Dates 7-8) to block 3.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Pragmatic, stepped-wedge cluster randomised controlled trial. It will include 8 clinical units, one unit per cluster. One cluster will commence with each step. All units will undertake a 6 week control period prior to the first randomisation. A six-week transition period will occur for each unit prior to the intervention phase data collection period.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The proportion of hospitalised patients who experience an adverse medicine event at baseline was assumed to be 0.26 based on data from a Veterans health service with integrated clinical pharmacists (akin to ‘usual care’ in the CARe-Med study). A meta-analysis found 45% of inpatient adverse medicine events were preventable (Hakkarainen et al. PLoS One. 2012;7(3):e33236), and the CARe-Med intervention aims to prevent 80% of these preventable events, which equates to preventing 36% of all medicine-related harm events. As the partnered prescribing intervention is anticipated to reach 80% of patients admitted during the trial period, the expected effective size was adjusted accordingly. Thus, we aim to detect a minimum absolute difference of 0.07 (i.e. from 26% to 19%, equivalent to a 28% relative reduction in medication-related harm events). Using a power of 80%, an inter-cluster correlation coefficient of 0.000736, and a two-sided significance level of <0.05, the required sample size was determined to be n=2320, (29 patients per cluster, per period) using the Shiny CRT Calculator as described by Hemming et al. (Int J Epidemiol. 2020;49(3):979-95).

Demographic and admission characteristics for patients admitted in each cluster and collated for control and intervention periods will be reported using descriptive statistics.

Analysis will be on an intention to treat basis. The intervention effect will be assessed using generalised linear mixed models with medication-related harm events treated as a binary outcome, accounting for cluster and time-period effects. The model will include fixed effects for time and treatment and random effects for cluster. An interaction term between time and each sequence will be added to allow for varying time trends across sequences. Subgroup comparisons will be made for patients in metropolitan vs regional sites and SA vs QLD, using the same model. Statistically significant difference will be defined by as P-value<0.05, adjusted for multiple comparisons in sub-group analyses (Bonferroni). Inter-cluster correlations will be computed to assess the similarity of outcomes within clusters and will be reported with 95% asymptotic confidence intervals.

As participants may be admitted more than once, a sensitivity analysis will be conducted to assess whether the intervention exerts a residual effect on subsequent admissions. If the sensitivity analysis identifies a residual effect of the intervention on subsequent admissions, the primary analysis will be adjusted accordingly to account for this effect, ensuring that the estimated intervention effect accurately reflects its impact on medication-related harm during individual admissions.

In patients who received the intervention an exploratory analysis will be conducted to assess the relationship between outcomes and the number/proportion of medicnes prescribed by the pharmacist.
Data from the transition months will be reported but not included in the final analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/06/2025
Actual
Date of last participant enrolment
Anticipated
28/02/2026
Actual
Date of last data collection
Anticipated
28/02/2026
Actual
Sample size
Target
2320
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA
Recruitment hospital [1] 27879 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 27880 0
Modbury Hospital - Modbury
Recruitment hospital [3] 27881 0
Noarlunga Health Service - Noarlunga Centre
Recruitment hospital [4] 27882 0
Mount Barker and District Health Services - Mount Barker
Recruitment hospital [5] 27883 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [6] 27884 0
Beaudesert Hospital - Beaudesert
Recruitment postcode(s) [1] 44075 0
5000 - Adelaide
Recruitment postcode(s) [2] 44076 0
5092 - Modbury
Recruitment postcode(s) [3] 44077 0
5168 - Noarlunga Centre
Recruitment postcode(s) [4] 44078 0
5251 - Mount Barker
Recruitment postcode(s) [5] 44079 0
4102 - Woolloongabba
Recruitment postcode(s) [6] 44080 0
4285 - Beaudesert

Funding & Sponsors
Funding source category [1] 318884 0
Government body
Name [1] 318884 0
Australian Department of Health and Aged Care, Medical Research Future Fund 2023 Clinician Researchers: Applied Research in Health Grant Opportunity
Country [1] 318884 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
Country
Australia
Secondary sponsor category [1] 321351 0
None
Name [1] 321351 0
Address [1] 321351 0
Country [1] 321351 0
Other collaborator category [1] 283510 0
University
Name [1] 283510 0
University of Queensland
Address [1] 283510 0
Country [1] 283510 0
Australia
Other collaborator category [2] 283511 0
Hospital
Name [2] 283511 0
SA Pharmacy, SA Health
Address [2] 283511 0
Country [2] 283511 0
Australia
Other collaborator category [3] 283512 0
Hospital
Name [3] 283512 0
Metro South Health, Queensland Health
Address [3] 283512 0
Country [3] 283512 0
Australia
Other collaborator category [4] 283513 0
University
Name [4] 283513 0
Flinders University
Address [4] 283513 0
Country [4] 283513 0
Australia
Other collaborator category [5] 283514 0
University
Name [5] 283514 0
Macquarie University
Address [5] 283514 0
Country [5] 283514 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317497 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 317497 0
Ethics committee country [1] 317497 0
Australia
Date submitted for ethics approval [1] 317497 0
06/01/2025
Approval date [1] 317497 0
25/03/2025
Ethics approval number [1] 317497 0
2025HRE00002
Ethics committee name [2] 317498 0
University of South Australia Human Research Ethics Committee
Ethics committee address [2] 317498 0
Ethics committee country [2] 317498 0
Australia
Date submitted for ethics approval [2] 317498 0
25/03/2025
Approval date [2] 317498 0
31/03/2025
Ethics approval number [2] 317498 0
206961
Ethics committee name [3] 317499 0
Metro South Human Research Ethics Committee
Ethics committee address [3] 317499 0
Ethics committee country [3] 317499 0
Australia
Date submitted for ethics approval [3] 317499 0
03/04/2025
Approval date [3] 317499 0
Ethics approval number [3] 317499 0
Ethics committee name [4] 317501 0
The University of Queensland Human Research Ethics Committee A
Ethics committee address [4] 317501 0
Ethics committee country [4] 317501 0
Australia
Date submitted for ethics approval [4] 317501 0
Approval date [4] 317501 0
Ethics approval number [4] 317501 0

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

Contacts
Principal investigator
Name 141246 0
Dr Jacinta Johnson
Address 141246 0
Bradley Building, City West Campus, University of South Australia, North Tce, Adelaide, SA 5000
Country 141246 0
Australia
Phone 141246 0
+61883021924
Fax 141246 0
Email 141246 0
[email protected]
Contact person for public queries
Name 141247 0
Jacinta Johnson
Address 141247 0
Bradley Building, City West Campus, University of South Australia, North Tce, Adelaide, SA 5000
Country 141247 0
Australia
Phone 141247 0
+61883021924
Fax 141247 0
Email 141247 0
[email protected]
Contact person for scientific queries
Name 141248 0
Jacinta Johnson
Address 141248 0
Bradley Building, City West Campus, University of South Australia, North Tce, Adelaide, SA 5000
Country 141248 0
Australia
Phone 141248 0
+61883021924
Fax 141248 0
Email 141248 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Individual participant data will not be shared to reduce the risk of participant reidentification.



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.