Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001243505
Ethics application status
Approved
Date submitted
19/09/2024
Date registered
10/10/2024
Date last updated
10/10/2024
Date data sharing statement initially provided
10/10/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
The impact of a multi-component medication safety bundle on medication safety in the adult resuscitation rooms of an Emergency Department
Scientific title
The impact of a multi-component medication safety bundle on medication safety in the adult resuscitation rooms of an Emergency Department
Secondary ID [1] 312929 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Medication errors 335093 0
Condition category
Condition code
Emergency medicine 331594 331594 0 0
Resuscitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will determine if a ‘multi-component medication safety bundle’ in adult resuscitations can reduce moderate and major medication errors in ED resuscitations.

To first identify the extent of the problem, baseline data is required from our study setting. In Phase I of the study, the observation of 169 medication administrations which meet our inclusion criteria will be undertaken, and data collected. The research nurse will be informed of a patient’s impending arrival to a resuscitation room by either pager (if an emergency “code call” is sent out), or by telephone call from the resuscitation room coordinator.

We will include any patient that presents to a resuscitation room, provided they meet the following inclusion criteria:
1. Patients aged over 18 years old
2. Present directly to an adult resuscitation room (R1-5), or are moved to a resuscitation room from elsewhere within the emergency department
3. a) Are likely to be administered at least four intravenous/ intramuscular/ intraosseous/ subcutaneous medications – OR –
b) Are likely to be administered at least one “high risk” medications (vasopressor or paralytic medication)

Exclusion criteria:
1. Resuscitations where the primary investigators of this study are involved in a clinical capacity will be excluded

Upon the arrival of the patient to the resuscitation room, the research nurse will assess the patient’s suitability for this study by confirming they meet all 3 of the inclusion criteria (either criterion 3a or 3b listed above) and none of the exclusion criteria. If the patient is to be included, the research nurse will make themselves known to the resuscitation Team Leader, and will clarify that they are present in a “hands-off” capacity only.
The research nurse will utilise the data collection package and document the occurrence of errors for each medication ordered, prepared, and administered. They will also observe and record any non-drug errors, pertaining to documentation and communication.

As well as the drug and non-drug errors, a number of patient demographic data points and supplementary data points will be collected to aid in answering our secondary objectives. The research nurse will also distribute a brief anonymous survey at the end of the resuscitation, to one doctor and one nurse involved in the prescription, preparation and/or administration of medication.

Following the successful data collection of 169 medication administrations, the multi-component medication safety bundle will then be introduced.

The multi-component medication safety bundle details:
The study looks primarily at the impact of having a dedicated ED resuscitation trained pharmacist that is both present in the resuscitation room and also providing impact through quality improvement, guideline implementation and education initiatives. The multi-component safety bundle will include a number of clinically relevant education interventions. These interventions will be led by expert clinical pharmacist with assistance from emergency medicine consultants, resuscitation nurses, nursing clinical
coaches, and nurse educators. These may involve teaching in face-to-face resuscitation simulations, at handover sessions, group or individual training and email communication. The frequency and duration of the training will be dependent on what focus areas for improvement are identified from phase I of the study and what normal day-to-day workflow allows. There is no specified frequency or duration at this stage.
Due to the large workforce within our department the adherence to the intervention (e.g training sessions and attendance) is not mandatory and monitoring of adherence will not be applicable.

The interventions will include some of the below:
- Improving utilisation of the “Resus Drug Flipbook”
- Communication of medication related verbal orders
- Sharing of common drug-drug, drug-patient and drug-herbal interactions to be aware of
- Resus antibiotic sepsis guideline changes
- Postpartum haemorrhage kit medication guidance updates
- The review of medication trolleys in the resuscitation room
- Correct labelling of resuscitation medications

Phase II of the study will be observing resuscitations following the implementation of the multicomponent medication safety bundle. Again, 169 medication administrations in resuscitations that meet the inclusion criteria will be observed by a research nurse, and the same number and type of errors will be watched for. At the end of the resuscitation, the same survey will be distributed to one doctor and one nurse involved in the prescription and administration of medication.

For each patient in phase I and phase II there can be multiple medication administrations that occur.
Intervention code [1] 329480 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339334 0
Moderate and major medication errors in ED resuscitations will be assessed as a composite primary outcome.

Timepoint [1] 339334 0
At the end of the patient presentation to adult resuscitation
Secondary outcome [1] 439542 0
Efficiency in drug administration
Timepoint [1] 439542 0
Throughout the patient presentation in adult resuscitation until the acute phase is complete.
The HCP survey is to be completed at the end of the resuscitation period.
Secondary outcome [2] 439543 0
Clinician satisfaction in medication safety
Timepoint [2] 439543 0
Throughout the patient presentation in adult resuscitation until the acute phase is complete.
This outcome will be assessed at the end of the acute phase.
Secondary outcome [3] 439545 0
Total number of medication errors regardless of severity
Timepoint [3] 439545 0
Throughout the patient presentation in adult resuscitation until the acute phase is complete. Outcome assessed at the end of the acute phase.

Eligibility
Key inclusion criteria
We will not actively seek to include any specific age, ethnicity or presenting complaint. We will include any patient that presents to a resuscitation room, provided they meet the following inclusion criteria:

1. Patients aged over 18 years old
2. Present directly to an adult resuscitation room (R1-5), or are moved to a resuscitation room from elsewhere within the emergency department
3. a) Are likely to be administered at least four intravenous/ intramuscular/ intraosseous/ subcutaneous medications – OR –
b) Are likely to be administered at least one “high risk” medications (vasopressor or paralytic medication)

It will be at the discretion of the research nurse present on the day to determine if they believe a resuscitation is likely to meet criterion 3a or 3b. If data collection commences on a resuscitation that then does not meet 3a or 3b, that data will be stored but the case will not be included in data collection, and another resuscitation will need to be added to ensure power is met.

Data will be collected during weekdays, between the hours of 07:00 and 14:30 or whenever an adequate number of clinical and research staff are present
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Resuscitations where the primary investigators of this study are involved in a clinical capacity will be excluded.

The clinical staff present in the resuscitation are also participants in this study. A Participant Information Sheet (PIS) will be distributed via email to the clinical Heads of Department (for example, General Surgery, Intensive Care) to distribute to their teams, as well as Emergency Department staff, to inform them that any resuscitation they attend may be selected to be included in this study. This PIS states that participation in this study is voluntary.

Study design
Purpose of the study
Educational / counselling / training
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
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
12/06/2024
Date of last participant enrolment
Anticipated
30/09/2027
Actual
Date of last data collection
Anticipated
30/09/2027
Actual
Sample size
Target
43
Accrual to date
8
Final
Recruitment outside Australia
Country [1] 26565 0
New Zealand
State/province [1] 26565 0
Auckland

Funding & Sponsors
Funding source category [1] 317361 0
Other
Name [1] 317361 0
Tupu Research Fund
Country [1] 317361 0
New Zealand
Primary sponsor type
Other
Name
Tupu Research Fund
Address
Country
New Zealand
Secondary sponsor category [1] 319736 0
None
Name [1] 319736 0
Address [1] 319736 0
Country [1] 319736 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316093 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 316093 0
Ethics committee country [1] 316093 0
New Zealand
Date submitted for ethics approval [1] 316093 0
20/03/2024
Approval date [1] 316093 0
26/04/2024
Ethics approval number [1] 316093 0
2024 FULL 20028

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

Contacts
Principal investigator
Name 136754 0
Dr Andrew Brainard
Address 136754 0
Middlemore Hospital - Emergency Department, 100 Hospital Road, Auckland, Otahuhu 2025
Country 136754 0
New Zealand
Phone 136754 0
+64212467423
Fax 136754 0
Email 136754 0
[email protected]
Contact person for public queries
Name 136755 0
Georgia Doyle
Address 136755 0
Middlemore Hospital - Emergency Department, 100 Hospital Road, Auckland, Otahuhu 2025
Country 136755 0
New Zealand
Phone 136755 0
+64210407709
Fax 136755 0
Email 136755 0
[email protected]
Contact person for scientific queries
Name 136756 0
Andrew Brainard
Address 136756 0
Middlemore Hospital - Emergency Department, 100 Hospital Road, Auckland, Otahuhu 2025
Country 136756 0
New Zealand
Phone 136756 0
+64212467423
Fax 136756 0
Email 136756 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?
This study uses identifiable patient data that are subject to restriction, including ethics, consent, and privacy issues. Anonymized data will be available on request from the corresponding author, where possible within these constraints for use.
When will data be available (start and end dates)?
From time of publication of main manuscript for 5 years.
Available to whom?
Researchers who provide a methodologically sound proposal.
Available for what types of analyses?
Available for meta-analyses
How or where can data be obtained?
Anonymised data will be available on request from the Primary Investigator. Dr Andrew Brainard. He can be contacted at [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.