Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000479101
Ethics application status
Approved
Date submitted
14/02/2019
Date registered
22/03/2019
Date last updated
22/03/2019
Date data sharing statement initially provided
22/03/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Emergency department clinicians’ perceptions on the use of patient controlled analgesia in emergency departments
Scientific title
Emergency department clinicians’ perceptions on the barriers and enablers to the use
of patient controlled analgesia in emergency departments
Secondary ID [1] 293129 0
None
Universal Trial Number (UTN)
Trial acronym
PCAED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain management
 305091 0
Patient controlled analgesia
 305092 0
Condition category
Condition code
Emergency medicine 304405 304405 0 0
Other emergency care
Anaesthesiology 310681 310681 0 0
Pain management
Public Health 310682 310682 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
Patient controlled analgesia (PCA) is a method widely used in surgical, obstetric, orthopaedic, and palliative care units to manage pain. PCA pumps are loaded with pre-filled syringes of an opioid analgesic, connected to a patient’s intravenous (IV) line, and analgesia is administered in set doses when the patient activates a button on the PCA. Lockout periods are pre-programed to prevent patients from receiving unsafe doses of the medication. Research in the post-operative environment has identified several advantages of PCAs including increased patient autonomy, decreased nursing workload, decreased time to receive analgesia, and improved patient satisfaction (McNicol et al., 2015). Due to these benefits, PCAs are used extensively in other settings however their use in Emergency Departments (EDs) is minimal or non-existent.

Interviews will be conducted with ED clinicians in nursing, medicine, and pharmacy disciplines at two participating sites. This purposeful sample will have direct experience and involvement with opioid prescribing or preparation in an ED and thus are an important component of the multidisciplinary team; it is anticipated they will provide useful insight and expertise from different perspectives. A single interview will be conducted with each participant. Interviews will be approximately fifteen minutes long and digitally recorded. The researcher will use an interview guide while conducting the interview.



References
McNicol, E. D., Ferguson, M. C., & Hudcova, J. (2015). Patient controlled opioid analgesia versus non-patient controlled opioid analgesia for postoperative pain. Cochrane Database of Systematic Reviews, 2015(6), 1–129.
Intervention code [1] 299376 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303641 0
Emergency department clinicians’ perceptions on the barriers to the use of patient controlled analgesia in emergency departments. Qualitative data will be analysed thematically to identify themes related to this outcome.
Timepoint [1] 303641 0
Each interview will last approximately fifteen minutes and qualitative data analysis will be conducted after each interview(s) have been conducted at study sties.
Secondary outcome [1] 367875 0
Emergency department clinicians’ perceptions on the facilitators of patient controlled analgesia use in emergency departments. Facilitators include actions, documents and equipment that enable or assist in the effective use of patient controlled analgesia. Qualitative data will be analysed thematically to identify themes related to this outcome.
Timepoint [1] 367875 0
Each interview will last approximately fifteen minutes and qualitative data analysis will be conducted after each interview(s) have been conducted at study sties.

Eligibility
Key inclusion criteria
Interviews will be conducted with ED clinicians in nursing, medicine, and pharmacy disciplines at two participating EDs. This purposeful sample will have direct experience and involvement with opioid prescribing or preparation in an ED and thus are an important component of the multidisciplinary team; it is anticipated they will provide useful insight and expertise from different perspectives.

Phase three: surveys will be distributed to ED doctors and nurses in Australia and New Zealand via the peak professional colleges and associations of ED doctors and nurses.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No experience in pain management (prescribing analgesia, assessing pain, dispensing analgesia and/or administering analgesia)

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Interviews will involve a purposeful sample. Theoretical sampling, in which decisions about samples are made during the research process, will be employed. The sample size will be determined by data saturation, when no new concepts or themes emerge during the data collection process. This technique will enable flexibility in data collection as new study findings emerge.

Phase 3: surveys will be distributed to approximately 6000 ED doctors and nurses who are members of professional organisations and colleges specifically for ED clinicians. Obtaining data from ED clinicians in Australia and New Zealand would increase the
generalisability of the survey results and enable the application of a wide range of analysis
including within and between group comparisons. A multinational survey will generate results that are sustainable and transferable across ED settings.

Data analysis
Qualitative data will be analysed thematically, adhering to the qualitative descriptive methodology and themes, patterns, and concepts will be analysed once the interviews are completed. Rigor of the analysis will be ensured by applying the criteria of authenticity, credibility, auditability or dependability, fittingness or transferability, and neutrality. QRS Nivo is a qualitative data analysis program that will be used for this research. Quantitative data will be analysed using univariate and multivariate statistical techniques with SPSS data analysis software (version 24). Analyses will be two-tailed and statistical significance will be defined by the standard 0.05 significance criterion for all tests.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/03/2018
Date of last participant enrolment
Anticipated
Actual
9/05/2018
Date of last data collection
Anticipated
Actual
9/05/2018
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 13152 0
St John of God Hospital, Murdoch - Murdoch
Recruitment hospital [2] 13153 0
St John of God Midland Public Hospital - Midland
Recruitment postcode(s) [1] 25694 0
6150 - Murdoch
Recruitment postcode(s) [2] 25695 0
6056 - Midland

Funding & Sponsors
Funding source category [1] 297755 0
Hospital
Name [1] 297755 0
St John of God Hospital Centre for Nursing and Midwifery Research
Country [1] 297755 0
Australia
Primary sponsor type
Individual
Name
Natasya Raja (PhD Candidate)
Address
St John of God Hospital Murdoch
Centre for Nursing and Midwifery Research (lower ground floor)
100 Murdoch Drive
Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 296792 0
Individual
Name [1] 296792 0
Dr Gail Ross-Adjie (principal supervisor)
Address [1] 296792 0
St John of God Hospital Murdoch
Centre for Nursing and Midwifery Research (lower ground floor)
100 Murdoch Drive
Murdoch WA 6150
Country [1] 296792 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298817 0
University of Notre Dame Australia HREC
Ethics committee address [1] 298817 0
Ethics committee country [1] 298817 0
Australia
Date submitted for ethics approval [1] 298817 0
18/10/2017
Approval date [1] 298817 0
13/11/2017
Ethics approval number [1] 298817 0
017169F
Ethics committee name [2] 298818 0
St John of God Health Care Human Research Ethics Committee
Ethics committee address [2] 298818 0
Ethics committee country [2] 298818 0
Australia
Date submitted for ethics approval [2] 298818 0
20/11/2017
Approval date [2] 298818 0
23/01/2018
Ethics approval number [2] 298818 0
1318

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

Contacts
Principal investigator
Name 78326 0
Ms Natasya Raja
Address 78326 0
St John of God Hospital Murdoch
Center for Nursing and Midwifery Research (lower ground floor)
100 Murdoch Drive, Murdoch 6150
Murdoch WA 6150
Country 78326 0
Australia
Phone 78326 0
+61 8 94389005
Fax 78326 0
Email 78326 0
[email protected]
Contact person for public queries
Name 78327 0
Natasya Raja
Address 78327 0
St John of God Hospital Murdoch
Center for Nursing and Midwifery Research (lower ground floor)
100 Murdoch Drive, Murdoch 6150
Murdoch WA 6150
Country 78327 0
Australia
Phone 78327 0
+61 8 94389005
Fax 78327 0
Email 78327 0
[email protected]
Contact person for scientific queries
Name 78328 0
Natasya Raja
Address 78328 0
St John of God Hospital Murdoch
Center for Nursing and Midwifery Research (lower ground floor)
100 Murdoch Drive, Murdoch 6150
Murdoch WA 6150
Country 78328 0
Australia
Phone 78328 0
+61 8 94389005
Fax 78328 0
Email 78328 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Qualitative study


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.