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Trial registered on ANZCTR


Registration number
ACTRN12624001108505
Ethics application status
Approved
Date submitted
8/08/2024
Date registered
13/09/2024
Date last updated
15/12/2024
Date data sharing statement initially provided
13/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Can virtual pharmacist-led prescribing help improve medication safety among hospital inpatients?
Scientific title
Effect of Virtual Partnered Pharmacist Medication Charting (VPPMC) on length of stay and medication safety for adult patients in rural Australian hospitals.
Secondary ID [1] 312681 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Medication error 334668 0
Condition category
Condition code
Public Health 331239 331239 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is based on the PPMC model developed in Victoria, however, pharmacy services will be delivered virtually. The virtual clinical pharmacy service utilises a range of modalities including the electronic health records, teleconferencing and videoconferencing using designated telehealth equipment such as portable wireless videoconferencing cart with two-way audio and visual including a tilt, pan and zoom camera lens to conduct patient reviews and discuss patient care with medical officers and nursing staff. Primary communication with patients is via videoconference, and teleconference and electronic documentation with medical officers, nurses and allied health. However this may change depending on need and particular circumstances e.g. multidisciplinary meetings are via videoconference.

The intervention will have a credentialed pharmacist take a best possible medication history and review venous thromboembolism (VTE) risk on all eligible patients, as soon as possible as part of admission to hospital. Patients will be prioritised for review based on clinical judgement and pharmacist workload, and medication history-taking is dependent on various factors including awaiting correspondence from other health care providers. Therefore, no specific timeframe has been set for the intervention.

After medication history-taking and review, the pharmacist will then create a medication management plan in collaboration with the medical officer. Once agreed upon, the pharmacist will electronically document the medication management plan and chart the patient's regular medication and VTE prophylaxis, co-signed by the medical officer. Relevant information is then communicated to the nurse.

VTE risk assessment is based on a standardised electronic form for medical officers to complete which helps identify risk factors for VTE and contraindications to VTE chemoprophylaxis. Clinical pharmacists can make recommendations and prescribe VTE prophylaxis as part of partnered charting but will not formally assess VTE risk using this electronic form.

A documentation template for PPMC will be developed, and will contain (per the draft local procedure):
- Reason for admission
- Current clinical issues
- Current Home Medications
- Changes to admission medications in consultation with the partnering medical officer
- VTE Risk Assessment (if completed) and prophylaxis considerations and dose
- Name of the partnering medical officer
- Pharmacist contact details
- Authorisation statement (“Nursing staff are authorised to administer medications approved by the medical practitioner signatory and charted by the pharmacist as documented on this inpatient progress note”)

The research team will ensure ongoing training and engagement with clinical staff for the duration of the study to ensure uptake of the intervention. However, it will not be possible or appropriate for all patients to receive VPPMC at the intervention sites, for example it will be quicker for a doctor to chart medications if a patient takes only one cholesterol tablet.


Informational training materials will be supplied by New South Wales Health and the Society of Hospital Pharmacists of Australia, who will provide training for accreditation of virtual pharmacists. Pharmacist accreditation is planned within the three months before intervention commencement.

A one-off PPMC training and credentialling program will be completed prior to the commencement of the intervention. The training is a combination of online and face-to-face learning with an oral assessment:
1. PPMC online learning module (45mins)
2. My Health Learning Online Modules
-- eMeds: Pharmacist Pathway (Documenting Allergies 15-20 mins, Home Medications 15-30 mins, Admission Reconciliation 15-30 mins, Medication Orders 15-30 mins, Medication Order Actions 20-40 mins, Medication Complex Orders 15-30 mins, Clinical Pharmacy Review 15-30 mins, PowerPlan 10-20 mins, Discharge Reconciliation 15-30 mins
-- eMeds: Fluid infusions – Prescribing (course code 327248785) (60-70 mins)
-- Safely prescribing and administering insulin (Course Code 194502204) (30 mins)
3. Supervised PPMC cases using an Entrustable Professional Activity (EPA) assessment tool until pharmacist reaches EPA Level 4 for independent credentialing (“Perform with minimal supervision, available if needed, essentially independent performance”), and Level 5 to credential others (“Supervise more junior colleagues” - per Australian Pharmacy Council)
4. OSCE facilitated by a senior pharmacist and a senior doctor (registrar or above) nominated by the medical unit.
Intervention code [1] 329207 0
Treatment: Other
Comparator / control treatment
Control sites in this cluster-randomised controlled trial will continue providing the current model of pharmacy service, wherein only medical officers are involved in charting medications. Hospital pharmacists subsequently obtain the best possible medication history and perform medication reconciliation to identify errors such as dosing errors and medication discrepancies, which will be discussed with the medical officer and suggestions enacted retrospectively. The medication history is taken as soon as possible after admission and reconciliation is performed as soon as practicable after the medical officer has charted medications.
Control group
Active

Outcomes
Primary outcome [1] 339014 0
Length of hospital stay
Timepoint [1] 339014 0
Upon discharge from the hospital
Secondary outcome [1] 438272 0
Time until medical review
Timepoint [1] 438272 0
Upon medical review
Secondary outcome [2] 438273 0
Time to medications being charted
Timepoint [2] 438273 0
Time at which the first medication admission reconciliation is completed
Secondary outcome [3] 438274 0
Incidence of hospital-acquired complications
Timepoint [3] 438274 0
Time of admission until discharge
Secondary outcome [4] 438275 0
Rates of medication reconciliation
Timepoint [4] 438275 0
At the conclusion of study
Secondary outcome [5] 438276 0
Length of stay in the Emergency Department (ED)
Timepoint [5] 438276 0
From admission to ED until discharge from ED
Secondary outcome [6] 438277 0
Discharge from hospital by 10:00.
Timepoint [6] 438277 0
At discharge
Secondary outcome [7] 438278 0
Costs of hospital admission (direct and indirect)
Timepoint [7] 438278 0
Time of admission until discharge, as documented in the electronic medical record.

Eligibility
Key inclusion criteria
- Patients aged 18 years or over
- Admitted to the ED of a rural/remote hospital in Western New South Wales Local Health District (WNSWLHD )
- Clinically reviewed by a pharmacist and a medical officer
- Has an expected length of stay of greater than 24 hours.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients admitted to hospital for more than 48 hours

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 because individual patient eligibility is determined after sites have been randomised to the intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size was calculated to identify a similar difference in length of stay (LOS) from the PPMC model implemented in Victoria. With 14 clusters in the intervention group and 14 clusters in the control group, to identify a mean difference of 0.26 (standard deviation of 1), set at alpha of 0.05, 80% power and intra-class correlation coefficient of 0.02, a total of 1,400 patients is required for this study.

All statistical 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 U tests or chi-squared tests, depending on the variable of interest. A two-sided p-value = 0.05 will be considered statistically significant.

An economic evaluation will be conducted depending on the trial outcomes. For instance, if it is found to be effective, a within-trial cost-effectiveness analysis of the VPPMC intervention on LOS in rural and regional hospitals will be conducted. The comparator will be the current best usual care models, with primary outcomes evaluated in the economic analysis, including identified medication-related problems and LOS. Incremental cost-effectiveness ratios will be calculated as the incremental cost per LOS in days.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/03/2025
Actual
Date of last participant enrolment
Anticipated
3/03/2026
Actual
Date of last data collection
Anticipated
31/03/2026
Actual
Sample size
Target
1400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 317113 0
Government body
Name [1] 317113 0
NSW Ministry of Health – Translational Research Grants Scheme
Country [1] 317113 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 320387 0
None
Name [1] 320387 0
Address [1] 320387 0
Country [1] 320387 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315866 0
Greater Western Human Research Ethics Committee
Ethics committee address [1] 315866 0
Ethics committee country [1] 315866 0
Australia
Date submitted for ethics approval [1] 315866 0
21/08/2024
Approval date [1] 315866 0
05/12/2024
Ethics approval number [1] 315866 0
2024/ETH01673

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

Contacts
Principal investigator
Name 136026 0
Dr Jonathan Penm
Address 136026 0
N371, Building A15 - The University of Sydney, Science Road, CAMPERDOWN NSW 2050
Country 136026 0
Australia
Phone 136026 0
+61286275806
Fax 136026 0
Email 136026 0
jonathan.penm@sydney.edu.au
Contact person for public queries
Name 136027 0
Brett Chambers
Address 136027 0
Virtual Clinical Pharmacy Service, Western NSW Local Health District. PO Box 4061, Dubbo, New South Wales 2830, Australia
Country 136027 0
Australia
Phone 136027 0
+61268098429
Fax 136027 0
Email 136027 0
Brett.Chambers@health.nsw.gov.au
Contact person for scientific queries
Name 136028 0
Brett Chambers
Address 136028 0
Virtual Clinical Pharmacy Service, Western NSW Local Health District. PO Box 4061, Dubbo, New South Wales 2830, Australia
Country 136028 0
Australia
Phone 136028 0
+61268098429
Fax 136028 0
Email 136028 0
Brett.Chambers@health.nsw.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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24085Ethical approval    HREC approval email 388242-(Uploaded-06-12-2024-01-12-50)-2024_ETH01673_ Application HREA - Approved.pdf


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.