Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001724864
Ethics application status
Approved
Date submitted
26/10/2021
Date registered
16/12/2021
Date last updated
19/12/2022
Date data sharing statement initially provided
16/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of the Collaborative Optimisation and Ordering of Medications (COOM) on prescribing safety in hospitalised patients
Scientific title
Collaborative Optimisation and Ordering of Medications (COOM): a trial of the effect of a team-based pharmacy model, including partnered physician-pharmacist prescribing, on prescribing errors in hospitalised adults admitted to General Medicine
Secondary ID [1] 305288 0
Metro South Health Research Support Scheme (MSH RSS): RSS_2021_124
Universal Trial Number (UTN)
U1111-1269-3915
Trial acronym
COOM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prescribing Error 323591 0
Medication Harm 323592 0
Condition category
Condition code
Public Health 321136 321136 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project will compare a Collaborative Optimisation and Ordering of Medications (COOM) model to routine/usual care.
This study is a non-randomised trial with patients included based on the medical team to which they are admitted. Medical teams included in this study have equivalent rostering of clinicians, and participate in an equivalent roster of admitting days. Admitted patients are
allocated to teams according to pre-allocated admitting days or prior knowledge of the patient to the medical team. Medical teams included in this trial (both intervention and control) are pre-selected based on expressions of interest from medical team consultants at the respective hospitals.
This trial is a controlled interventional study that will compare a COOM model with usual care within a general medicine service at two hospital sites. One medical team at each site be allocated a COOM pharmacist (intervention team) whereas other medical teams, receiving usual pharmacy service, will act as control groups. The COOM workflow involves the usual workflow of a doctor assessing the patient and making a diagnosis and the pharmacist conducting a medication history and clinically reviewing medications. The point of difference with the COOM model is that the doctor and pharmacist will collaboratively review medications and develop a plan to optimise the patient’s medications together. In routine/usual care this process, including review of medications and developing plan, usually happens separately by both the doctor and pharmacist. As a result, prescribing errors are retrospectively identified and communicated by the pharmacist to the prescriber. The medication review process involves review of the patient's usual medications (through best possible medication history), reconciliation of these medications in the context of their medical history and reason for presentation to hospital and clinical review (eg. appropriate dose). The proposed COOM model will involve a pharmacist embedded in the medical team - who actively undertakes this review process at the point of prescribing. The review process will occur at key prescribing moments in the Medical Teams usual workflow (including admission to hospital, during consultant ward rounds and discharge from hospital). As such, the specific time required for each review will be individualised to the patient as it will vary depending on the complexity of the patient, medical team workload and hospital factors.
In the COOM model, the agreed plan will be documented, and medications will be ordered by either the doctor (usual practice) or the pharmacist (extended scope role). In the control groups, all medications will be ordered by the doctor (usual practice). This intervention will occur at key prescribing moments across a patient’s entire hospital stay (eg. at admission to hospital, on consultant ward rounds throughout the admission and at discharge).
The pharmacists on the intervention team will be pharmacists with general registration with Australian Health Practitioner Regulation Agency (AHPRA). They will undergo a credentialling program, designed and administered by the study team, to assess their competency in the COOM model i.e. working with prescribers and ordering medications on an electronic medication chart.
Adherence to intervention will be captured through the electronic medication management software at the two hospitals where audits of pharmacist prescribing, and progress notes will be captured and quantified. Retrospective data will be collected on a weekly basis as the intervention is conducted. This data will help the research team to monitor adherence to protocol.
All pharmacists across both the intervention teams and control teams will be available to the respective medical teams at the same times on the same days, in line with usual pharmacy hours (i.e. Monday to Friday 8:00am to 5:00pm). Both intervention teams and control teams will receive usual weekend and public holiday pharmacy service.
The intended study duration will be 6 months.
Intervention code [1] 321693 0
Prevention
Comparator / control treatment
The control group will receive usual pharmacy service, which involves a best possible medication history and admission reconciliation and medication optimisation by pharmacist within 24 hours of admission. Medication reviews by pharmacist during inpatient admission. Discharge reconciliation and discharge medication list, if deemed necessary by pharmacist according to hospital guidelines.
Control group
Active

Outcomes
Primary outcome [1] 328924 0
The primary outcome is patients with one or more prescribing errors at 24 hours from admission to hospital. Prescribing errors will be assessed by an independent research pharmacist through comparison of the Pharmacist Admission History Note (i.e. the best possible medication history) to what was prescribed within the first 24 hours of admission. The independent research pharmacist will utilise their clinical knowledge, guidelines and other resources available to a clinical pharmacist to evaluate the appropriateness of prescribing within this time period. The independent research pharmacist will have retrospective access to all relevant electronic clinical documentation for each patient (i.e., progress notes, observations, laboratory test results and medication charts).
Timepoint [1] 328924 0
At 24 hours from admission to hospital
Secondary outcome [1] 400875 0
The number of patients with one or more prescribing errors on discharge. Prescribing errors will be assessed by an independent research pharmacist through comparison of the Pharmacist Admission History Note (i.e. the best possible medication history) to what was prescribed within the first 24 hours of admission. The independent research pharmacist will utilise their clinical knowledge, guidelines and other resources available to a clinical pharmacist to evaluate the appropriateness of prescribing within this time period. The independent research pharmacist will have retrospective access to all relevant electronic clinical documentation for each patient (i.e., progress notes, observations, laboratory test results and medication charts).
Timepoint [1] 400875 0
At discharge from hospital.
Secondary outcome [2] 400876 0
The composite endpoint of clinical significance and severity of prescribing errors. The clinical significance and severity of prescribing errors will be analysed by an independent research pharmacist using a validated tool the Society of Hospital Pharmacists (SHPA) risk matrix. This risk matrix involves rating the consequence and probability of the error. All errors will be reviewed by an independent research pharmacist and a random selection of 20% these errors will be authenticated by a blinded independent multidisciplinary expert panel comprising a senior general medicine physician, a clinical pharmacologist and a senior clinical pharmacist. The panel will use the same SHPA risk matrix which will require the panel to agree on the probability of a scenario occurring and the likelihood of the impact, assuming no intervention. The potential consequence or ‘risk’ of each error will be determined in the hypothetical scenario that it persisted without intervention for 48 hours. Errors will be classified retrospectively on an ordinal severity scale of one to five (insignificant, minor, moderate, major or catastrophic risk) and similarly on an ordinal scale for likelihood of occurrence A to E (almost certain, likely, possible, unlikely, rare).
Timepoint [2] 400876 0
At 24 hours from admission and at discharge from hospital.
Secondary outcome [3] 400877 0
Number of patients with a medication-related harm event at any time during inpatient hospital stay. Medication harm events will be identified in two ways:
1) through review of all patient records by an independent research pharmacist who will utilise their clinical knowledge, experience and other resources available to a clinical pharmacist to identify medication harm throughout the patient’s hospital stay. The independent research pharmacist will have retrospective access to all relevant electronic clinical documentation for each patient (i.e., progress notes, observations, laboratory test results and medication charts).
2) through retrospective identification of ICD-10 Y codes for inpatient medication harm.

A causality analysis will be conducted using the World Health Organisation (WHO) Upsalla Monitoring Centre (UMC) Criteria.
Timepoint [3] 400877 0
At any time during inpatient admission to hospital
Secondary outcome [4] 400878 0
The composite endpoint of number and clinical significance of deprescribed medications at discharge. To assess deprescribing, data will be collected on the number of regular medications prescribed on admission from the pharmacist best possible medication history documented in the Pharmacist Admission Note (PAN) and at discharge from the Discharge Medication Record and/or discharge summary. This will be recorded as both total numbers and numbers within medication classes, defined by the WHO’s Anatomical, Therapeutic Chemical (ATC) Classification system. Deprescribing (including type of medication and reason for cessation, reduction or wean) will be retrospectively identified by the IRP through the documentation of this activity in progress notes, pharmacy interventions, in discharge summaries and in Discharge Medication Records (DMR). The effectiveness of deprescribing will be assessed by reviewing a sample of matched cohort of discharged patients from the intervention and control group. A multidisciplinary expert panel comprising a senior general medicine physician, a clinical pharmacologist and a senior clinical pharmacist, independent to the care of the patient, will use the CEASE framework (a previously validated tool).
Timepoint [4] 400878 0
At discharge from hospital.
Secondary outcome [5] 400879 0
Length of patient stay (LOS) including index admission and acute admission. LOS will be sourced from the hospital's administrative databases and will be extracted by the Casemix team, a team independent to the patients care that are experienced in runing these reports.
Timepoint [5] 400879 0
at discharge
Secondary outcome [6] 400880 0
Cost-effectiveness of the intervention. Costs for patient admission will be sourced from the hospital's administrative databases and will be extracted by the Casemix team, a team independent to the patients care that are experienced in running these reports. Cost-effectiveness will be determined by quantifying the difference in costs and benefits between the two arms at study completion. Effects will be derived from the information collected in the primary outcome and secondary outcomes. Costs will include the direct and indirect costs of the intervention pharmacist, coupled with the direct costs of patient care, provided by the hospital administrative team (or calculated using LOS if data is unavailable). An incremental effect and cost will be estimated for the two comparators; this will be used to determine an incremental cost-effectiveness ratio (ICER). Sensitivity analyses will be conducted to ensure results are robust and to determine the effect of the most influential variables. Sensitivity analysis will be conducted in accordance with best practice guidelines written by the International Professional Society for Health Economics and Outcomes Research (ISPOR) and reported following the Consolidated Health Economic Evaluation Reporting Standards (CHEERS).
Timepoint [6] 400880 0
At completion of intervention

Eligibility
Key inclusion criteria
All adult admission to the General Medicine team allocated the intervention team will automatically be treated using the COOM model (intervention), while patients in the other General Medicine Teams not receiving the COOM model will be treated with the standard pharmacy model and allocated as controls.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they are <18 years of age, have length of in-patient stay <24 hours, are admitted to the Medical Assessment and Planning Unit, or do not receive a pharmacist best possible medication history during admission. They will not be included in the primary outcome analysis if they were not under the designated medical team during their first 24 hours of hospital admission.

Study design
Purpose of the study
Prevention
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size was determined based on information obtained from a local pilot study conducted at one of the two study sites. This study found a rate of 44% patients with one or more errors on discharge reconciliation in the intervention group compared to a rate of 71% in the control group, with a recruitment rate of 1:1.63 (intervention:control).
We aim to detect a significant absolute difference of 10%. Specifying a power of 80% and a two-sided a = 0.05, and using Epitools sample size calculator to detect a significant difference between two proportions using Chi-squared test, The sample size required was calculated as 124 patients (47 in the intervention and 77 in the control).
Normally distributed continuous data will be presented as means (+/-SD), ordinal and skewed data as medians with interquartile range (IQR).P<0.05 will be deemed statistically significant. The statistical significance of differences in proportions will be determined in Chi-squared tests or, if the value in a cell is less than 5, Fisher Exact tests. Absolute differences in the error rate, as the primary outcome, will be presented together with the number needed to treat (NNT) to prevent one patient with one or more errors. The statistical significance of differences in means will be evaluated in Student t tests and medians with Mann-Whitney U tests.

Cost-effectiveness will be determined by quantifying the difference in costs and benefits between the two arms at study completion in determining an incremental cost-effectiveness ratio (ICER). Effects will be derived from the information collected in the primary outcome and secondary outcomes. Costs will include the direct and indirect costs of the intervention pharmacist, coupled with the direct costs of patient care according to length of stay changes. Sensitivity analyses will be conducted to ensure results are robust and to determine the effect of the most influential variables. An incremental effect and cost will be estimated for the two comparators; this will be used to determine an incremental cost-effectiveness ratio. Sensitivity analysis will be conducted in accordance with best practice guidelines written by the International Professional Society for Health Economics and Outcomes Research (ISPOR) and reported following the Consolidated Health Economic Evaluation Reporting Standards (CHEERS).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2023
Actual
Date of last participant enrolment
Anticipated
30/06/2023
Actual
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
124
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 20510 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 20511 0
Logan Hospital - Meadowbrook
Recruitment postcode(s) [1] 35287 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 35288 0
4131 - Meadowbrook

Funding & Sponsors
Funding source category [1] 309660 0
Hospital
Name [1] 309660 0
Metro South Health
Country [1] 309660 0
Australia
Primary sponsor type
Hospital
Name
Metro South Health
Address
L7, Translation Research Institute
37 Kent St
Woolloongabba QLD 4102
Country
Australia
Secondary sponsor category [1] 310678 0
None
Name [1] 310678 0
Address [1] 310678 0
Country [1] 310678 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309427 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 309427 0
Ethics committee country [1] 309427 0
Australia
Date submitted for ethics approval [1] 309427 0
16/09/2021
Approval date [1] 309427 0
06/06/2022
Ethics approval number [1] 309427 0
HREC/2021/QMS/72694
Ethics committee name [2] 312158 0
The University of Queensland Human Research Ethics Committee (HREC)
Ethics committee address [2] 312158 0
Ethics committee country [2] 312158 0
Australia
Date submitted for ethics approval [2] 312158 0
25/08/2022
Approval date [2] 312158 0
23/09/2022
Ethics approval number [2] 312158 0
2022/HE001531

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

Contacts
Principal investigator
Name 114126 0
Ms Courtney Hill
Address 114126 0
Princess Alexandra Hospital
199 Ipswich Rd, Woolloongabba QLD 4102
Country 114126 0
Australia
Phone 114126 0
+61 7 3176 2478
Fax 114126 0
+61 7 3176 2800
Email 114126 0
[email protected]
Contact person for public queries
Name 114127 0
Courtney Hill
Address 114127 0
Princess Alexandra Hospital
199 Ipswich Rd, Woolloongabba QLD 4102
Country 114127 0
Australia
Phone 114127 0
+61 7 3176 2111
Fax 114127 0
+61 7 3176 2800
Email 114127 0
[email protected]
Contact person for scientific queries
Name 114128 0
Courtney Hill
Address 114128 0
Princess Alexandra Hospital
199 Ipswich Rd, Woolloongabba QLD 4102
Country 114128 0
Australia
Phone 114128 0
+61 7 3176 2111
Fax 114128 0
+61 7 3176 2800
Email 114128 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data will be published/may be provided with ethics approval only by request.
Patient data: sex, age, presenting complaint, co-morbidities, number and types of medications, medication harm events and length of stay.
Clinician data: experience and qualifications.
When will data be available (start and end dates)?
Data will be available to the investigator team upon completion of data collection (estimated December 2022). Data will be publicly available immediately following publication, with no end date determined.
Available to whom?
Individual participant data (IPD) for this trial will not be publically available. De-identified data will be published. Further de-identified data, underlying published results only, may be provided with ethics approval only by request.
Available for what types of analyses?
Data will be available on request for only data underlying published results to achieve the aims in the approved proposal.
How or where can data be obtained?
Access is subject to approvals by Principal Investigator and the Metro South Human Research Committee via contacting the Principal Investigator Courtney Hill (CH), Princess Alexandra Hospital Pharmacy Department, Ph. 3176 2478, Email: [email protected]


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.