Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000983808
Ethics application status
Approved
Date submitted
28/05/2021
Date registered
26/07/2021
Date last updated
26/07/2021
Date data sharing statement initially provided
26/07/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Feasibility and acceptability of a Virtual Clinical Pharmacy Service (VCPS) for elective orthopaedic inpatients in an Australian tertiary metropolitan hospital
Scientific title
Feasibility and acceptability of a Virtual Clinical Pharmacy Service (VCPS) for elective orthopaedic inpatients in an Australian tertiary metropolitan hospital
Secondary ID [1] 304339 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Medication management 322100 0
Medication errors 322686 0
Condition category
Condition code
Public Health 319815 319815 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a non-randomised feasibility study of Virtual Clinical Pharmacy Services at an elective orthopaedic ward at a tertiary metropolitan hospital. The Virtual Clinical Pharmacy Service will provide remote clinical support to patients, doctors and nurses using digital technologies including video-conference, the electronic medical record and electronic medicine management. The virtual pharmacist will provide services consistent with recognised standards of face to face clinical pharmacy from Monday to Friday from 8am to 430pm for a 12 week trial period. The trial will be evaluated through routinely collected health data (service utilisation) and perceived patient and staff acceptability.
Intervention code [1] 320695 0
Treatment: Other
Intervention code [2] 321075 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327680 0
Uptake and utilisation of the VCPS using routinely collected health data (composite primary outcome)

Routinely collected health data from the patient electronic medical record will be used to evaluate the feasibility of the VCPS. This feasibility will be evaluated by assessing the utilisation of a virtual pharmacy service, detection of preventable medication harms and uptake of medication related recommendations.

Routinely collected data includes:
- Total number of patients seen by a virtual pharmacist
- Number of pharmacist clinical interventions (detection of preventable medication harms) and update of recommendations
- Number of best possible medication histories/ medication management plans
- Number of medication reviews
- Number of patient friendly medication lists
Timepoint [1] 327680 0
Continuous for the study period
Secondary outcome [1] 396210 0
Perceived patient acceptability of VCPS as assessed by Patient Reported Experience Measures Survey.

A Patient Reported Experience Measures Survey (PREM) will be used to assess if the VCPS is perceived to be an acceptable service by patients in a metropolitan setting. Participants who have seen the virtual pharmacist will be invited to complete a 12 question PREMS delivered via SMS test message (estimated N=300).
Timepoint [1] 396210 0
Immediately post-completion of interaction with VCPS.
Secondary outcome [2] 396211 0
Perceived staff acceptability of VCPS as assessed by staff focus group.

At the end of the feasibility trial a 30 minute, virtual, audio-recorded, qualitative focus group will be conducted with staff (estimated N=10) exposed to the VCPS. Questions will be used to explore the perceived acceptability of the service including the issues, benefits, barriers and overall acceptability of the VCPS. Thematic analysis will be utilised to deductively and inductively identify barriers and facilitators, but open to unexpected findings.
Timepoint [2] 396211 0
At 12 weeks post implementation

Eligibility
Key inclusion criteria
Admitted elective orthopaedic inpatients.
Doctors, nurses, pharmacists and other health professionals whom work at the study location.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Outpatients

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistical analysis will summarise the VCPS service utilisation. Descriptive statistical analysis will summarise the PREM results and linear regression models will be used to explore characteristics associated with the overall score.

The focus groups will be audio-recorded, transcribed verbatim and entered into QSR NVivo. Thematic analysis will be utilised to deductively and inductively identify barriers and facilitators, but open to unexpected findings.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
27/04/2021
Date of last participant enrolment
Anticipated
Actual
7/07/2021
Date of last data collection
Anticipated
Actual
7/07/2021
Sample size
Target
310
Accrual to date
Final
401
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 19589 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 34196 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 308710 0
Government body
Name [1] 308710 0
NSW Ministry of Health
Country [1] 308710 0
Australia
Primary sponsor type
Government body
Name
Western NSW Local Health District
Address
29 Hawthorn St, Dubbo NSW 2830
Country
Australia
Secondary sponsor category [1] 310010 0
None
Name [1] 310010 0
Address [1] 310010 0
Country [1] 310010 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308634 0
Greater Western Human Research Ethics Committee
Ethics committee address [1] 308634 0
Ethics committee country [1] 308634 0
Australia
Date submitted for ethics approval [1] 308634 0
20/01/2021
Approval date [1] 308634 0
11/03/2021
Ethics approval number [1] 308634 0
2021/ETH00097

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

Contacts
Principal investigator
Name 111382 0
Dr Shannon Nott
Address 111382 0
Western New South Wales Local Health District, 29 Hawthorn St, Dubbo NSW 2830
Country 111382 0
Australia
Phone 111382 0
+61 2 6809 8600
Fax 111382 0
+61 2 680 97974
Email 111382 0
shannon.nott@health.nsw.gov.au
Contact person for public queries
Name 111383 0
Brett Chambers
Address 111383 0
Western New South Wales Local Health District, 29 Hawthorn St, Dubbo NSW 2830
Country 111383 0
Australia
Phone 111383 0
+61 2 6809 8647
Fax 111383 0
+61 2 680 97974
Email 111383 0
brett.chambers@health.nsw.gov.au
Contact person for scientific queries
Name 111384 0
Shannon Nott
Address 111384 0
Western New South Wales Local Health District, 29 Hawthorn St, Dubbo NSW 2830
Country 111384 0
Australia
Phone 111384 0
+61 2 6809 8600
Fax 111384 0
+61 2 680 97974
Email 111384 0
shannon.nott@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
11791Study protocol  shannon.nott@health.nsw.gov.au 382081-(Uploaded-28-05-2021-10-29-33)-Study-related document.pdf
11792Informed consent form  shannon.nott@health.nsw.gov.au 382081-(Uploaded-28-05-2021-12-01-04)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
5271Study results articleYeshttps://doi.org/10.1002/jppr.1853 Chambers, B., Allan, J., Webster, E., Packer, A. a... [More Details]

Documents added automatically
No additional documents have been identified.