Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001034426
Ethics application status
Approved
Date submitted
1/08/2016
Date registered
4/08/2016
Date last updated
4/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of Partnered Pharmacist Charting at Admission and Discharge
Scientific title
Evaluation of Partnered Pharmacist Charting at Admission and Discharge
Secondary ID [1] 289808 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hospital admission 299726 0
Condition category
Condition code
Public Health 299660 299660 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Partnered pharmacist charting: on admission to selected General Medical or Emergency Short Stay Units at a major tertiary institution (Alfred Hospital), patients' regular medications will be charted by a credentialled clinical pharmacist, and endorsed by a medical officer.
At time of discharge from hospital, patients from selected General Medicical units will have the medication management section of their discharge summary completed by a credentialed clinical pharmacist, and endorsed by a medical officer.

Procedure:
Medication reconciliation on admission and discharge medication counselling both include face-to-face sessions with the patient as routine care. Admission medication charting and discharge summary completion do not replace this, nor do they add extra patient contact.
Admission:
The pharmacist takes a medication history (routine care), performs VTE risk assessment, has a discussion with the admitting medical officer about current problems and the medication management plan is agreed upon. Pre-admission medications and VTE prophylaxis are charted by the pharmacist; followed by a discussion between the treating nurse and pharmacist about the plan, including urgent medications to be administered, drug-related monitoring and reasons for any changes.
Discharge:
Following discharge medication and prescription review (routine care) and discussion with the medical team, the pharmacist electronically enters the following into the medication management section of the discharge summary:
-current list of all medications the patient should be taking on discharge, listed according to whether they are new (including indication), changed (including reason), or unchanged.
-a list of all medications ceased during admission, including reasons
-medication allergies
-smoking status, and management during admission
-actions required by the GP, including medications requiring review
Once complete, the discharge summary is reviewed and endorsed by the discharging medical officer

Admission medication charting takes approximately 15-20 minutes depending on the number and complexity of medications
Discharge summary completion takes approximately 5-15 minutes depending on the number and complexity of medications.

The duration of the observation period is four months.

Based on the allocation of units to interventions, patients will receive either the admission or discharge intervention, but not both, per admission. Patients readmitted to hospital during the study period may be allocated to receive the same or different intervention during their next admission, as each admission is considered a new event.

For patients in ESSU, only the admission charting intervention is applicable.

Regular auditing of medication charts and discharge summaries was undertaken. Charts or summaries completed by a medical officer in the pharmacist-arm units were excluded (including charts completed outside of pharmacist working hours).
Intervention code [1] 295481 0
Other interventions
Comparator / control treatment
Patients admitted to the remaining General Medical or Emergency Short Stay Units will have their regular medications charted by a medical officer on admission, with pharmacist review occurring within 24 hours, as is usual care.
At time of discharge from hospital, patients from remaining General Medical units will have the medication management section of their discharge summary completed by a medical officer as usual.
Control group
Active

Outcomes
Primary outcome [1] 299123 0
Medical errors identified within 24 hours of admission, collected by clinical pharmacists during clinical care (at this institution, daily medication review is carried out by clinical pharmacists for all patients)
Timepoint [1] 299123 0
24 hours after admission
Primary outcome [2] 299124 0
Medical errors identified in the discharge medication summary at time of discharge from hospital, retrospectively collected by an independent data collector reviewing medical records
Timepoint [2] 299124 0
Discharge from hospital
Secondary outcome [1] 326249 0
Severity of admission medical errors identified as above, assessed using a risk matrix by an independent panel made up of a general medical physician, emergency medicine physician, and clinical pharmacist.
Timepoint [1] 326249 0
Within 24 hours of admission
Secondary outcome [2] 326250 0
Severity of discharge medical errors identified as above, assessed using a risk matrix by an independent panel made up of a general medical physician, emergency medicine physician, and clinical pharmacist.
Timepoint [2] 326250 0
Discharge from hospital

Eligibility
Key inclusion criteria
Admission charting: All patients admitted as an inpatient under the general medical unit (GMU) or emergency short stay unit (ESSU) at the Alfred Hospital within pharmacist working hours (7am to 9pm, Monday to Sunday)
Discharge charting: All patients discharged from an inpatient stay under the general medical unit (GMU) at the Alfred Hospital within pharmacist working hours (7am to 9pm, Monday to Sunday)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients not admitted under General Medicine or Emergency Short Stay.
(For admission charting): patients admitted outside of pharmacist working hours
(For discharge charting): patients discharged outside of pharmacist working hours

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)
This was a cluster randomised trial.

The GMU is divided into four geographically-based subunits, each with equivalent rostering of clinicians, participating in an equivalent rostering of admitting days. Admitted patients are allocated to teams according to geographical bed availability. This allocation is carried out by inpatient bed managers who were unaware that the study was taking place. There were no differences among number or seniority of staff among the four subunits. The four GMU subunits were randomised to receiving a discharge summary with a medication management plan completed by a pharmacist in one cluster of two subunits, with standard medical discharge summaries continuing in the other cluster of the remaining two subunits.

Units were randomly selected using a random number generator to correspond to the four units by the primary investigator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Units were randomly selected using a random number generator to correspond to the four units by the primary investigator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Normally distributed continuous data are presented using means (standard deviation) while ordinal and skewed data are presented using medians (inter-quartile range). Statistical significance was defined by a p-value of <0.05. Statistical significance of difference in proportions was determined using a cluster-weighted chi-squared test or where value in a cell was less than 5, Fisher’s Exact test was used. Differences in the primary outcome were presented using risk of an error and the number needed to treat (NNT) to prevent one error. Statistical significance of difference in means was evaluated using the Student’s t-test and difference in medians was evaluated using the Wilcoxon Rank-Sum test.
For sample size calculation, the proportion of standard medical charted patients with an error was assumed to be 0.30. We aimed to detect a minimum clinically significant absolute difference of 0.10. Using a power of 90% and a two-sided significance (alpha) level of 0.05, the total sample size required was 824, with 412 in each arm and 206 patients within each cluster. The inter-cluster correlation coefficient was expected to be very small, approaching zero and an adjustment for the design effect was not performed. All analyses were conducted using Stata v 12.0 (College Station, Texas).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
16/03/2015
Date of last participant enrolment
Anticipated
Actual
27/07/2015
Date of last data collection
Anticipated
2/10/2015
Actual
3/11/2015
Sample size
Target
600
Accrual to date
Final
832
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6345 0
The Alfred - Prahran
Recruitment postcode(s) [1] 13887 0
3004 - Prahran

Funding & Sponsors
Funding source category [1] 294195 0
Government body
Name [1] 294195 0
Department of Health and Human Services (DHHS)
Country [1] 294195 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] 293019 0
None
Name [1] 293019 0
Address [1] 293019 0
Country [1] 293019 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295598 0
Alfred Human Research Ethics Committee
Ethics committee address [1] 295598 0
55 Commercial Road
Melbourne Victoria 3004
Ethics committee country [1] 295598 0
Australia
Date submitted for ethics approval [1] 295598 0
25/11/2014
Approval date [1] 295598 0
19/12/2014
Ethics approval number [1] 295598 0
539/14

Summary
Brief summary
Objectives - The aim of this study was to evaluate the effectiveness of pharmacists completing the medication management plan in the medical discharge summary for preventing medication errors.
Design - We conducted a cluster randomised controlled trial comparing pharmacist completed medication management plans in the discharge summary to standard medical discharge summaries among patients discharged following an inpatient stay under a general medical unit.
Setting - This trial was conducted at an adult major referral hospital in metropolitan Melbourne, Australia with an annual Emergency Department (ED) attendance of approximately 60,000 patients
Participants The evaluation included patients’ discharge summaries written in the period of 16th March 2015 to 27th July 2015.
Interventions - Patients randomised to the intervention had their medication management plan completed by a pharmacist.
Main outcome measures - The primary outcome variable was an erroneous discharge summary related to a medication error as identified by an independent assessor, who was not part of the patient’s admission process.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67882 0
Prof Michael Dooley
Address 67882 0
Pharmacy Department
Alfred Hospital
55 Commercial Road
Melbourne Victoria 3004
Country 67882 0
Australia
Phone 67882 0
+61390762061
Fax 67882 0
Email 67882 0
[email protected]
Contact person for public queries
Name 67883 0
Miss Erica Tong
Address 67883 0
Pharmacy Department
Alfred Hospital
55 Commercial Road
Melbourne Victoria 3004
Country 67883 0
Australia
Phone 67883 0
+61390762061
Fax 67883 0
Email 67883 0
[email protected]
Contact person for scientific queries
Name 67884 0
Miss Erica Tong
Address 67884 0
Pharmacy Department
Alfred Hospital
55 Commercial Road
Melbourne Victoria 3004
Country 67884 0
Australia
Phone 67884 0
+61390762061
Fax 67884 0
Email 67884 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
SourceTitleYear of PublicationDOI
Dimensions AIReducing medication errors in hospital discharge summaries: a randomised controlled trial2017https://doi.org/10.5694/mja16.00628
N.B. These documents automatically identified may not have been verified by the study sponsor.