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Trial registered on ANZCTR


Registration number
ACTRN12616000961448
Ethics application status
Approved
Date submitted
5/07/2016
Date registered
21/07/2016
Date last updated
2/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of Partnered Pharmacist Medication Charting at Admission: Expansion Project
Scientific title
Evaluation of Partnered Pharmacist Medication Charting at Admission: Expansion Project
Secondary ID [1] 289618 0
Nil
Universal Trial Number (UTN)
Trial acronym
PPMC-Expansion
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hospital admission 299403 0
Condition category
Condition code
Public Health 299384 299384 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A Partnered Pharmacist Medication Charting (PPMC) Model has been in place at Alfred Health in the General Medical Unit since 2012. A pharmacist, in consultation with a medical officer, charts the patient's regular medications on admissions to the unit. A randomised trial demonstrated that the PPMC significantly reduced medication errors on admission compared to the standard medical model.
From the 1st August 2016 the PPMC model will be implemented as standard of care in General Medical Units at the following Victorian health services (hospitals): Melbourne Health (Royal Melbourne Hospital), Monash Health (Monash Medical Centre, Dandenong Hospital), Barwon Health (University Hospital Geelong ), Eastern Health (Box Hill Hospital, Maroondah Hospital) and Echuca Regional Health (Echuca Hospital).
Each participant will be followed from hospital admission to one month post-discharge, with pre and post phases running for 6 months prior to 1/8/16 and for 7 months post 1/8/16. Data for months passed (Feb to mid-June) will be collected retrospectively.
Intervention code [1] 295230 0
Not applicable
Comparator / control treatment
This is a pre/post study. Data will be collected for patients admitted before implementation of the PPMC in August 2016 to act as comparison data..
During the 'pre'-period, all patients will have their medications charted on admission by a doctor as is currently standard care. From mid-June to August, data has been prospectively collected. Medical record review will be used to retrospectively collect data prior to June 2016.
The pre-stage will include patient admitted to hospital from February 2016 to August 2016.
Control group
Active

Outcomes
Primary outcome [1] 298847 0
Number of medication errors made during admission charting, assessed by medical record review.
Timepoint [1] 298847 0
Time of admission
Secondary outcome [1] 325404 0
Risk level of errors made during admission, assessed by a panel comprising of an Emergency physician, a General Medicine physician and a clinical pharmacist. The panel will review errors identified by medical record review (primary outcome), and assign a consensus score based on risk severity and the probability of occurrence using the validated Australian Standards for Risk Management in Healthcare risk classification matrix.
Timepoint [1] 325404 0
Admission
Secondary outcome [2] 325405 0
Length of hospital stay, as assessed by review of medical records.
Timepoint [2] 325405 0
Discharge
Secondary outcome [3] 336835 0
Cost of hospital admission to the health service, assessed by using hospital Performance and Analysis/coding reports for inpatient episodes.
Timepoint [3] 336835 0
At Discharge

Eligibility
Key inclusion criteria
Patients admitted to the General Medical unit for inpatient admission
Over 18 years of age
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients not admitted to the General Medical unit for inpatient admission.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Random sample
Timing
Both
Statistical methods / analysis
Comparisons between study phases will be performed using commercially available statistical software with the advice of a biostatistician. Continuous variables will be compared using means (plus standard deviation) or medians (plus interquartile range) depending on underlying distribution of data. Where appropriate, a Student t-test will be used for normally distributed continuous variables or a Mann-Whitney U test where data is found to be non-normally distributed. Wilcoxon rank-sum test will be used for ordinal variables and chi-square or Fisher's exact test as appropriate for categorical variables. A two-sided p-value of 0.05 will be considered to be statistically significant.

To detect a change in the length of stay of 5% with 80% power at a 5% level of significance, a sample of approximately 5,500 patients in each arm (total of 11,000 patients) is required.
Based on the current admission data to the general medical units at the 6 health services involved, approximately 15,000 patients should be able to be included during the proposed study period.

Recruitment
Recruitment status
Completed
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)
VIC
Recruitment hospital [1] 6115 0
Dandenong Hospital - Dandenong
Recruitment hospital [2] 6116 0
Box Hill Hospital - Box Hill
Recruitment hospital [3] 6117 0
The Alfred - Prahran
Recruitment hospital [4] 6118 0
Maroondah Hospital - Ringwood East
Recruitment hospital [5] 6119 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [6] 6120 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [7] 6121 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [8] 6122 0
Echuca Regional Health - Echuca

Funding & Sponsors
Funding source category [1] 293998 0
Government body
Name [1] 293998 0
Department of Health and Human Services (DHHS)
Address [1] 293998 0
50 Lonsdale St
Melbourne Victoria 3000
Country [1] 293998 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health Pharmacy Department
Address
Pharmacy Department
55 Commercial Rd
Melbourne Victoria 3004
Country
Australia
Secondary sponsor category [1] 292815 0
None
Name [1] 292815 0
none
Address [1] 292815 0
nil
Country [1] 292815 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295409 0
Alfred Human Research Ethics Committee
Ethics committee address [1] 295409 0
55 Commercial Rd
Melbourne Victoria 3004
Ethics committee country [1] 295409 0
Australia
Date submitted for ethics approval [1] 295409 0
19/04/2016
Approval date [1] 295409 0
03/05/2016
Ethics approval number [1] 295409 0
HREC/16/Alfred/40

Summary
Brief summary
A Partnered Pharmacist Medication Charting (PPMC) model has been in place at Alfred Health in the General Medical Unit since 2012. A randomised trial conducted in 2015 demonstrated that PPMC significantly reduced medication errors on admission compared to the standard medical model.
From the 1st of August 2016, the PPMC will be implemented as a new standard of care in the General Medical units of 6 health services across Victoria. The purpose of this study is to evaluate this new standard of care.
This pre/post study is not seeking participants. All patients admitted to the General Medical units of these services will be enrolled. Ethics approval and a waiver of consent has been granted by the Alfred HREC.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67022 0
Prof Michael Dooley
Address 67022 0
Pharmacy Department
Alfred Hospital
55 Commercial Rd
Melbourne 3004 VIC
Country 67022 0
Australia
Phone 67022 0
+61390762061
Fax 67022 0
Email 67022 0
m.dooley@alfred.org.au
Contact person for public queries
Name 67023 0
Miss Erica Tong
Address 67023 0
Pharmacy Department
Alfred Hospital
55 Commercial Rd
Melbourne 3004 VIC
Country 67023 0
Australia
Phone 67023 0
+61390762061
Fax 67023 0
Email 67023 0
e.tong@alfred.org.au
Contact person for scientific queries
Name 67024 0
Miss Erica Tong
Address 67024 0
Pharmacy Department
Alfred Hospital
55 Commercial Rd
Melbourne 3004 VIC
Country 67024 0
Australia
Phone 67024 0
+61390762061
Fax 67024 0
Email 67024 0
e.tong@alfred.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary