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Trial registered on ANZCTR


Registration number
ACTRN12619001757101
Ethics application status
Approved
Date submitted
5/12/2019
Date registered
11/12/2019
Date last updated
8/01/2020
Date data sharing statement initially provided
11/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Realising the benefits of clinical pharmacy in the bush:
The efficacy and scalability of a virtual clinical pharmacy service (VCPS) in rural and remote New South Wales health facilities
Scientific title
A stepped wedge trial of efficacy and scalability of a virtual clinical pharmacy service (VCPS) in rural and remote New South Wales health facilities
Secondary ID [1] 300011 0
NSWMOH-FE7801
Universal Trial Number (UTN)
U1111-1244-9803
Trial acronym
VCPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Medication management 315497 0
Medication errors 315499 0
Condition category
Condition code
Public Health 313787 313787 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The VCPS will evaluate virtual clinical pharmacy support to inpatient care in facilities in WNSWLHD and FWLHD where there is no access to on site clinical pharmacy services. The aim of the project is not to evaluate the effectiveness of clinical pharmacy services which is well defined in the literature.
The virtual clinical pharmacists will provide a telehealth service which is consistent with conventional face to face hospital pharmacy services. Depending on the patients’ medical history and reason for admission they may receive one or more of the pharmacy activities summarised below:
• Patient prioritisation and recognition of high-risk patients
• Medication reconciliation particularly during transitions of care
• Patient education
• Staff education
• Health facility engagement
• Medication review and addressing polypharmacy
• Documentation and intervention recording
• Antimicrobial stewardship
The virtual pharmacists will utilise the eMR, eMeds and a “Wallie” wireless teleconferencing cart with two–way audio and visual (located in all WNSWLHD and FWLHD health facilities) to provide clinical pharmacy services to study sites.
Frequency/duration - The virtual pharmacy intervention baseline data collection will begin February 2020 and intervention data from May 2020. Virtual pharmacy intervention data collection will continue for the stepped wedge analysis until December 2020. Post service implementation data collection and evaluation will then continue until June 2021. The Pharmacists will work during business hours, Monday-Friday of each week over the study period where it is anticipated they will see approximately 5-10 patients per pharmacist per day depending on the complexity of patients’ medication regimens for the period of time the hospital is in the intervention stage of the study. This will vary from site to site from 14 months to eight months depending on where they are in the randomised step of the study. Patients who are at the highest risk of medication related harm will be prioritised for review. Mode of delivery is determined by referral to the pharmacist from medical or nursing staff and prioritisation by the pharmacist. Prioritisation is based on the definition from the NSQHS Standard 4- medication safety and the Society of Hospital Pharmacists of Australia (SHPA) Standards of Practice.
Medication reconciliation (Med Rec) is a formal process intended to prevent medication errors and medication related problems at transition points in patient care. Virtual clinical pharmacists will conduct Med Rec on admission, discharge or transfer and document the best possible medication history in eMeds. Interventions will be raised for issues that require prescriber or nursing management. Interventions of immediate clinical concern will be followed up with direct communication between pharmacist and site doctor or nurse. To ensure continuity of medication management on discharge back to the community, the pharmacist will provide an updated medication list on discharge.
Where appropriate, the virtual clinical pharmacist will provide comprehensive information to the patient or carer to enable safe and effective use of the medications. This will be tailored to suit the patient’s individual circumstances and may be in the form of verbal instructions, demonstration, education, a medication list, written advice or a consumer medicines information sheet.
Medication order review involves assessing all current and recent medication orders with the aim of optimising quality use of medicines, patient outcomes and minimise medication related problems. The virtual clinical pharmacist will take into account patient specific factors and provide advice on the most appropriate dose, dosage form, timing and duration of therapy so that risk of medication related problems are minimised. The virtual clinical pharmacist will do this by:
• Reviewing all prescribed medication orders
• Optimising chronic disease therapy
• Identifying drug related causes of admission
• Detecting medication interactions
• Reviewing medications that may contribute to falls risk
• Optimising venous thromboembolism (VTE) prophylaxis
• Providing antimicrobial stewardship review
• Providing monitoring for narrow therapeutic drugs
The virtual clinical pharmacists will document identified actual and potential medication related problems, clinical decisions and suggested changes to medication therapy in the patient’s eMR.
The virtual clinical pharmacists, project lead or other investigators will work on a coordinated communication, engage and change management process with study sites to ensure the new model of care in embedded into practice. This will involve providing education and training on the service with the aim of building rapport and ensure a successful implementation. This may involve activities such as site visits, telephone consults and videoconferencing.
Adherence to the intervention is monitored via VCare (virtual care) routine monitoring and reporting of telehealth functionality.
Intervention code [1] 316281 0
Treatment: Other
Comparator / control treatment
The hospital sites are their own controls. The virtual pharmacy intervention will be delivered using a stepped wedge cluster randomised trial design, where the intervention is sequentially implemented in the eight facilities. The ‘steps’ are the order in which each site cross-over from the control condition (pre-VCPS) to the intervention condition (VCPS). The sequence of the steps is also randomised, allowing for control of potential confounding temporal trends. This cross-over will occur across 8 steps (one site per step), each one month apart (with a two month ‘in-transition’ period).
Control group
Active

Outcomes
Primary outcome [1] 322202 0
The proportion of separations (“discharged home by the hospital”) where the medical reconciliation occurred on admission. Medical reconciliation is assessed via routine reports on entries in the electronic medical record.
Timepoint [1] 322202 0
Continuous for the study period
Primary outcome [2] 322203 0
The proportion of separations (“discharged home by the hospital”) where the medical reconciliation occurred on discharge. Medical reconciliation is assessed via routine reports on entries in the electronic medical record.
Timepoint [2] 322203 0
Continuous for the study period
Secondary outcome [1] 377699 0
28-day readmission to hospital. The outcome is assessed via routine reports on patient records comparing those who saw a pharmacist with those who did not.
Timepoint [1] 377699 0
One month after discharge
Secondary outcome [2] 377700 0
Number of falls in hospital. The outcome is assessed via routine reports on patient records comparing those who saw a pharmacist with those who did not. Falls are reported in an on-line incident management system (IMS) that is connected to the eMR.
Timepoint [2] 377700 0
Continuous during study period
Secondary outcome [3] 377702 0
Detection of medication-related errors. Medication related errors are identified through the medication reconciliation process and recorded on the patient's eMR.
Timepoint [3] 377702 0
The VCPS will be fully implemented after 11 months with all 8 hospitals receiving the VCPS. Process and outcome measures such as medication reconciliation, hospital readmissions, length of stay and falls data will be collected for baseline data from time period 1 and intervention data from time period 4. This pragmatic design, which is common to service delivery evaluations, is appropriate for interventions where simultaneous delivery of interventions is difficult and removal of the intervention would be inappropriate.

Eligibility
Key inclusion criteria
• Inpatients and emergency presentations in the participating hospitals. Inclusion criteria for the hospital is more than 20 separations per month and no pharmacy service on site.
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Outpatients
• Residential Aged Care patients
• Transitional Aged Care patients
• Hospital in the Home patients

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Hospitals eligible to participate in the study were allocated by contacting the holder of the allocation schedule who was "off-site"
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The virtual pharmacy intervention will be delivered using a stepped wedge cluster randomised trial design, where the intervention is sequentially implemented in the eight facilities. The ‘steps’ are the order in which each site cross-over from the control condition (pre-VCPS) to the intervention condition (VCPS). The sequence of the steps is also randomised, allowing for control of potential confounding temporal trends. This cross-over will occur across 8 steps (one site per step), each one month apart (with a two month ‘in-transition’ period). The VCPS will be fully implemented after 11 months with all 8 hospitals receiving the VCPS.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Across the eight sites we conservatively estimate a referral rate of 29 patients per month yielding approximately 2088 patients over the stepped wedge intervention period. Assuming a baseline medical reconciliation rate on admission of 11% (a similar rate for discharge medical reconciliations), an intra-class correlation of 0.05, and an average of 29 patient separations per site per month,) we expect we would have over 90% power to detect an absolute 10% increase in the proportion of reconciliations performed on admission and discharge, with a type 1 error rate of 2.5%.
The economic analysis will consist of a cost-effectiveness analysis (CEA) and cost-benefit analysis (CBA). These analyses will be conducted in accordance with international best-practice for such analyses in health care including: adoption a health sector perspective; transparent and scientific methods to identify, measure and value both costs and outcomes; modelling and uncertainty testing of input parameters; and, interpretation of results within a broader decision-making framework. The CEA will answer the question of whether the VCPS is more cost-effective than compared to treatment as usual; the CBA will consider the rate of return on investing in the VCPS. Both analyses will rely on health care utilisation data that identifies and measures resource use associated with the VCPS including: additional pharmacist time to deliver the intervention; patient and clinician education; and, any system level changes that have occurred to facilitate the implementation of the intervention.
Change in 28 day re-admission will be used as the primary outcome in the CEA. The CBA will attempt to quantify a wider range of outcomes associated with the VCPS that can be valued in monetary terms such as LOS, the cost of treating adverse events (falls, medication-related errors) and potentially preventable admissions. Monte Carlo analysis will be used to derive 95% uncertainty intervals for costs and outcome with results presented in a scatterplot (i.e. cost-effectiveness plane). The results of the CEA will be considered in the context of other decision-making criteria such as: capacity of the intervention to reduce inequity; acceptability to stakeholders; feasibility; sustainability; and, potential for other consequences. Results of the CBA will be expressed as a ratio of benefits to costs whereby a benefit cost ratio > 1, suggests that the VCPS is a good return on investment.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 15414 0
Warren Multi Purpose Health Service - Warren
Recruitment hospital [2] 15415 0
Balranald Multi Purpose Service - Balranald
Recruitment hospital [3] 15416 0
Wentworth District Hospital - Wentworth
Recruitment hospital [4] 15417 0
Gilgandra Multi Purpose Service - Gilgandra
Recruitment hospital [5] 15418 0
Cobar District Hospital - Cobar
Recruitment hospital [6] 15419 0
Canowindra Soldiers Memorial Hospital - Canowindra
Recruitment hospital [7] 15420 0
Narromine Hospital & Community Health - Narromine
Recruitment hospital [8] 15421 0
Bourke Multi Purpose Service - Bourke
Recruitment postcode(s) [1] 28735 0
2824 - Warren
Recruitment postcode(s) [2] 28736 0
2715 - Balranald
Recruitment postcode(s) [3] 28737 0
2648 - Wentworth
Recruitment postcode(s) [4] 28738 0
2827 - Gilgandra
Recruitment postcode(s) [5] 28739 0
2835 - Cobar
Recruitment postcode(s) [6] 28740 0
2804 - Canowindra
Recruitment postcode(s) [7] 28741 0
2821 - Narromine
Recruitment postcode(s) [8] 28742 0
2840 - Bourke

Funding & Sponsors
Funding source category [1] 304464 0
Government body
Name [1] 304464 0
New South Wales Ministry of Health
Address [1] 304464 0
100 Christie St, St Leonards NSW 2065
Country [1] 304464 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] 304734 0
None
Name [1] 304734 0
Address [1] 304734 0
Country [1] 304734 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304897 0
Greater Western Human Research Ethics Committee
Ethics committee address [1] 304897 0

Howick Street
BATHURST NSW 2795
Ethics committee country [1] 304897 0
Australia
Date submitted for ethics approval [1] 304897 0
22/11/2019
Approval date [1] 304897 0
05/12/2019
Ethics approval number [1] 304897 0
2019/ETH13355

Summary
Brief summary
We are doing a research project to evaluate the Virtual Clinical Pharmacy Service (VCPS) that is being delivered to 8 hospitals in Western and Far West NSW Local Health Districts via a video link. The aim of the virtual pharmacy is to improve medication management, reduce medication harm, help patients manage their medications, and support staff with patients. Routine data collection from patients' electronic medical record will identify if medication management improves, medication harms such as falls are reduced and if people are less likely to be readmitted to hospital compared to those who do not see a pharmacist.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98570 0
Dr Shannon Nott
Address 98570 0
Western New South Wales Local Health District, 29 Hawthorn St, Dubbo NSW 2830
Country 98570 0
Australia
Phone 98570 0
+61 2 68098600
Fax 98570 0
Email 98570 0
shannon.nott@health.nsw.gov.au
Contact person for public queries
Name 98571 0
Dr Shannon Nott
Address 98571 0
Western New South Wales Local Health District, 29 Hawthorn St, Dubbo NSW 2830
Country 98571 0
Australia
Phone 98571 0
+61 2 68098600
Fax 98571 0
Email 98571 0
shannon.nott@health.nsw.gov.au
Contact person for scientific queries
Name 98572 0
Dr Shannon Nott
Address 98572 0
Western New South Wales Local Health District, 29 Hawthorn St, Dubbo NSW 2830
Country 98572 0
Australia
Phone 98572 0
+61 2 68098600
Fax 98572 0
Email 98572 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?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 6047 0
Study protocol
Citation [1] 6047 0
Link [1] 6047 0
Email [1] 6047 0
shannon.nott@health.nsw.gov.au
Other [1] 6047 0
Type [2] 6048 0
Informed consent form
Citation [2] 6048 0
Link [2] 6048 0
Email [2] 6048 0
shannon.nott@health.nsw.gov.au
Other [2] 6048 0
Attachment [2] 6048 0
Type [3] 6049 0
Ethical approval
Citation [3] 6049 0
Link [3] 6049 0
Email [3] 6049 0
shannon.nott@health.nsw.gov.au
Other [3] 6049 0
Attachment [3] 6049 0
Summary results
No Results