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Trial registered on ANZCTR


Registration number
ACTRN12616001425482
Ethics application status
Approved
Date submitted
28/09/2016
Date registered
13/10/2016
Date last updated
2/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of Pharmacist Charting at Admission to Residential Care
Scientific title
Evaluation of Pharmacist Charting at Admission to Residential Care
Secondary ID [1] 290232 0
PPMC Residential Care
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hospital admission 300419 0
Condition category
Condition code
Public Health 300280 300280 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pharmacist generated interim medication charts to facilitate the transfer of medication information when patients are transferred from an inpatient hospital admission to a
residential care facility.

On discharge from General Medical units, a seven (7) day interim medication chart generated by partnered pharmacist medication charting and authorised by a medical officer will be supplied along with the discharge summary and discharge prescriptions. This chart is to be used by the residential care facility until the patient is seen by their usual provider.

This intervention will begin approximately three months after data collection begins (in order to gather baseline/pre-implementation data) and run for 3 months.
Intervention code [1] 296009 0
Other interventions
Comparator / control treatment
Patients discharged from General Medical units to residential care facilities before the interim medication charts are implemented. These patients are supplied with a discharge summary with a medication management plan and discharge prescriptions as per standard care.

Data will be collected prospectively beginning mid-October 2016, for a 3 month period, before the intervention is implemented.
Control group
Active

Outcomes
Primary outcome [1] 299761 0
Number of medication errors as identified by comparing intended medication management plans on discharge with patients' care facility medication charts
Timepoint [1] 299761 0
10 days post hospital discharge
Secondary outcome [1] 328043 0
Proportion of patients with an updated medication administration chart in the 7 days post-admission to the RCF (either interim or long term medication administration chart)
identified by reviewing medication charts
Timepoint [1] 328043 0
7 days post discharge
Secondary outcome [2] 328044 0
Proportion of patients for whom locum medical practitioner attendance was required within 7 days of transfer for the purpose of writing or updating a medication chart identified by reviewing medical records
Timepoint [2] 328044 0
7 days post hospital discharge
Secondary outcome [3] 328045 0
Number of medication administration errors identified in the 7 days post-admission to the RCF identified by reviewing medication charts
Timepoint [3] 328045 0
7 days post hospital discharge
Secondary outcome [4] 328053 0
Number of significant medication administration errors identified in the 7 days post-admission to the RCF as determined by a blinded expert panel identified by medication record review
Timepoint [4] 328053 0
7 days post hospital discharge
Secondary outcome [5] 328054 0
Number of patients readmitted to hospital within 7 days and 30 days of discharge to a RCF due to medication administration errors at the RCF identified by medical record review
Timepoint [5] 328054 0
7 and 30 days post hospital discharge

Eligibility
Key inclusion criteria
Hospital admission and discharge from Alfred Health
A current patient of the following residential aged care facility on admission to hospital (ie not a new patient to facility following discharge): Royal Freemasons, Jewish Care, Aged Care Services Australia, Emmy Monash Aged Care, Abberfield Aged Care Facility, Menarock Aged Care Services
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients discharged to residential care facilities not listed above.
Patients discharged outside pharmacist working hours (7am to 9pm, Monday to Sunday)
Patients who attend the Emergency Department but are not admitted as inpatients
Patients who are returning to a RCF and have had no medication changes made during hospitalisation
Children and/or young people (<18 years of age)

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
Other
Other design features
Pre/post
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Comparisons between the pre and post standard of care will be performed using commercially available statistical software. Continuous variables will be compared using means (plus standard deviation) or medians (plus inter-quartile range) depending on the underlying distribution of the 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. The 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.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
17/10/2016
Actual
17/10/2016
Date of last participant enrolment
Anticipated
28/04/2017
Actual
30/05/2017
Date of last data collection
Anticipated
30/05/2017
Actual
1/07/2017
Sample size
Target
300
Accrual to date
Final
235
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6748 0
The Alfred - Prahran
Recruitment postcode(s) [1] 14392 0
3004 - Prahran

Funding & Sponsors
Funding source category [1] 294595 0
Government body
Name [1] 294595 0
Department of Health and Human Services (DHHS)
Country [1] 294595 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health Pharmacy Department
Address
Pharmacy Department
55 Commercial Road
Melbourne Victoria 3004
Country
Australia
Secondary sponsor category [1] 293463 0
None
Name [1] 293463 0
Address [1] 293463 0
Country [1] 293463 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296042 0
Alfred Human Research Ethics Committee
Ethics committee address [1] 296042 0
Ethics committee country [1] 296042 0
Australia
Date submitted for ethics approval [1] 296042 0
31/08/2016
Approval date [1] 296042 0
26/09/2016
Ethics approval number [1] 296042 0
HREC/16/Alfred/117

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

Contacts
Principal investigator
Name 69322 0
Prof Michael Dooley
Address 69322 0
Pharmacy Department
Alfred Hospital
55 Commercial Road
Melbourne Victoria 3004
Country 69322 0
Australia
Phone 69322 0
+61390762061
Fax 69322 0
Email 69322 0
[email protected]
Contact person for public queries
Name 69323 0
Erica Tong
Address 69323 0
Pharmacy Department
Alfred Hospital
55 Commercial Road
Melbourne Victoria 3004
Country 69323 0
Australia
Phone 69323 0
+61390762061
Fax 69323 0
Email 69323 0
[email protected]
Contact person for scientific queries
Name 69324 0
Erica Tong
Address 69324 0
Pharmacy Department
Alfred Hospital
55 Commercial Road
Melbourne Victoria 3004
Country 69324 0
Australia
Phone 69324 0
+61390762061
Fax 69324 0
Email 69324 0
[email protected]

No information has been provided regarding IPD availability


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.