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Trial registered on ANZCTR
Registration number
ACTRN12625000092493
Ethics application status
Approved
Date submitted
20/11/2024
Date registered
28/01/2025
Date last updated
28/01/2025
Date data sharing statement initially provided
28/01/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
The impact of emergency medicine pharmacists on medication safety for critically ill patients in the resuscitation area of an emergency department
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Scientific title
The impact of emergency medicine pharmacists on medication safety for critically ill patients in the resuscitation area of an emergency department
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Secondary ID [1]
313391
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Medication error
335759
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Resuscitation
336460
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Condition category
Condition code
Emergency medicine
332315
332315
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0
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Resuscitation
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Public Health
332512
332512
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0
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Health service research
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Patients triaged to the resuscitation area of the emergency department (ED) will either have a pharmacist present during the resuscitation event or not. Patients triaged to a resuscitation bay in the Princess Alexandra Hospital (PAH) ED during the resuscitation pharmacist’s allocated working hours will fall into the intervention group. The intervention pharmacist was a senior pharmacist who attended the resuscitation area with the ED resuscitation team in response to an eligible patient presentation to assist with medication related activities during the critical care event.
The pharmacist will use local, national and international therapeutic and other medication guidelines to assist the other members of the resuscitation team with medication management activities
Pharmacist roles and activities could include: medication information provision and advice, administration advice such as dilution and rate of administration, preemptive and timely supply of medication, double-check of medications before administration, documentation of allergies, therapeutic recommendations (e.g. medication choice, dose and administration), documentation of medication history and medication review to identify medication related problems and ensure medications are optimised.
The pharmacist will be at the patients bedside for the duration of the acute resuscitation event or until there presence is required for another patient or their assistance is no longer required for medication related activities for the patient
A retrospective review of the medical record will identify and medication errors and record interventions documented by the pharmacist
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Intervention code [1]
329994
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Treatment: Other
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Intervention code [2]
330409
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Prevention
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Comparator / control treatment
Patients triaged to a resuscitation bay outside the pharmacists allocated working hours, will fall into the control group.
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Control group
Active
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Outcomes
Primary outcome [1]
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Medication error - composite of all error categories
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Assessment method [1]
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Direct observation or retrospective record review. Medication errors will be classified into relevant descriptive categories (for example drug class) and error type according to the National Coordinating Council for Medication Error Reporting and Prevention Taxonomy of Medication Errors.
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Timepoint [1]
339937
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Baseline only. During the patient's resuscitation event management occurring within the emergency department
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Secondary outcome [1]
441985
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Time to medication administration
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Assessment method [1]
441985
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Direct observation or retrospective record review. Time to medication administration will be calculated from time of emergency department presentation (triage time) to the time medication administration was recorded.
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Timepoint [1]
441985
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Baseline only. During the patient's resuscitation event management occurring within the emergency department
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Secondary outcome [2]
441986
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Adherence to guidelines
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Assessment method [2]
441986
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Retrospective record review. Adherence to guidelines will be assessed by the investigator following retrospective record review based on published national, district and hospital guidelines.
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Timepoint [2]
441986
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Baseline only. During the patient's resuscitation event management occurring within the emergency department
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Secondary outcome [3]
441989
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Accurate documentation on the electronic Medication Administration Record
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Assessment method [3]
441989
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Instances of incomplete MAR documentation were recorded as Error Category A as per the National Coordinating Council for Medication Error Reporting and Prevention Taxonomy of Medication Errors (no error - circumstances that have the capacity to cause error). These events occurred when medications were administered during resuscitation management, but the administration was not recorded on the patients’ medication administration record.
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Timepoint [3]
441989
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Baseline only. During the patient's resuscitation event management occurring within the emergency department
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Eligibility
Key inclusion criteria
Patients presenting to the emergency department and allocated to the resuscitation area who are:
- assigned an Australasian Triage Scale (ATS) category 1 or category 2 for a medical condition
- toxicological related condition or overdose
- patients with suspected sepsis
- requiring an immediate response following an internal ED alarm
- referred to the pharmacist by the ED resuscitation team
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients under 18
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
Data will be entered into an ExcelTM spreadsheet. Medication errors will be classified into relevant descriptive categories (likely drug class), and the hospital risk categories of major, minor, and no risk. Categories will be determined by the research team and a sample will be confirmed by a blinded expert panel.
Chi-squared test will be used to confirm statistical significance between medication errors in the control and intervention groups overall, and within the descriptive categories and risk categories. The primary and secondary outcomes will be reported using descriptive statistics including mean time to events, mean event counts in each cohort and outputs from statistical significance tests between the intervention and usual care cohorts.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
3/03/2025
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Actual
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Date of last participant enrolment
Anticipated
31/12/2025
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Actual
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Date of last data collection
Anticipated
31/01/2026
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Actual
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Sample size
Target
300
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
27347
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Princess Alexandra Hospital - Woolloongabba
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Recruitment postcode(s) [1]
43438
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4102 - Woolloongabba
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Funding & Sponsors
Funding source category [1]
317830
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Charities/Societies/Foundations
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Name [1]
317830
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Princess Alexandra Hospital Research Foundation
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Address [1]
317830
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Country [1]
317830
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Australia
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Primary sponsor type
Hospital
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Name
Princess Alexandra Hospital
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Address
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Country
Australia
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Secondary sponsor category [1]
320163
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None
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Name [1]
320163
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Address [1]
320163
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Country [1]
320163
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Other collaborator category [1]
283301
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University
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Name [1]
283301
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University of Queensland
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Address [1]
283301
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Country [1]
283301
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
316517
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Metro South Human Research Ethics Committee
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Ethics committee address [1]
316517
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https://metrosouth.health.qld.gov.au/research/about-us/hrec
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Ethics committee country [1]
316517
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Australia
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Date submitted for ethics approval [1]
316517
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28/05/2019
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Approval date [1]
316517
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04/10/2019
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Ethics approval number [1]
316517
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HREC/2019/QMS/54845 (Oct ver 2)
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Summary
Brief summary
Medication errors are an important cause of harm in Emergency Departments (EDs). The resuscitation area of Emergency Departments are busy, high risk environments in which patients who are in a critical condition are treated. Pharmacists have demonstrated an ability to improve medication safety in EDs and improve medicine use. However, the resuscitation area does not usually have a dedicated pharmacist. The aim of this study is to determine if the presence of an ED pharmacist in the resuscitation area to assist with the treatment of very unwell patients has a benefit to these patients. The hypothesis for this study is that an emergency medicine Pharmacist in the ED resuscitation team setting will reduce medication errors, help doctors and nurses give critical medicines more quickly, improve documentation of medications on medication charts, and optimise patient outcomes.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Ms Elizabeth Currey
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Address
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Princess Alexandra Hospital, 199 Ipswich Rd, Woolloongabba, QLD, 4102
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Country
138134
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Australia
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Phone
138134
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+61 0434871811
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Fax
138134
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Email
138134
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elizabeth.currey@health.qld.gov.au
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Contact person for public queries
Name
138135
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Elizabeth Currey
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Address
138135
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Princess Alexandra Hospital, 199 Ipswich Rd, Woolloongabba, QLD, 4102
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Country
138135
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Australia
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Phone
138135
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+61 07 3176 7444
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Fax
138135
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Email
138135
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elizabeth.currey@health.qld.gov.au
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Contact person for scientific queries
Name
138136
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Elizabeth Currey
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Address
138136
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Princess Alexandra Hospital, 199 Ipswich Rd, Woolloongabba, QLD, 4102
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Country
138136
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Australia
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Phone
138136
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+61 0434871811
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Fax
138136
0
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Email
138136
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elizabeth.currey@health.qld.gov.au
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
•
Individual participant data (IPD) for this trial will not be publicly available. De-identified data will be published. Further de-identified data, underlying published results only, may be provided with ethics approval only by request.
Conditions for requesting access:
•
-
What individual participant data might be shared?
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De-identified data will be published/may be provided with ethics approval only by request.
Patient data: sex, age, presenting complaint, co-morbidities, time to medication administration, medication adherence to guidelines, medication harm events and length of stay.
Clinician data: profession
What types of analyses could be done with individual participant data?
•
Data will be available on request for only data underlying published results to achieve the aims in the approved proposal.
When can requests for individual participant data be made (start and end dates)?
From:
Data will be available to the investigator team upon completion of data collection (estimated December 2025). Data will be publicly available immediately following publication, with no end date determined.
To:
-
Where can requests to access individual participant data be made, or data be obtained directly?
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Access is subject to approvals by Principal Investigator and the Metro South Human Research Committee via contacting the Principal Investigator Elizabeth Currey, Princess Alexandra Hospital Pharmacy Department, Ph. 3176 2478, Email: elizabeth.currey@health.qld.gov.au
Are there extra considerations when requesting access to individual participant data?
No
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.
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