Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000897763p
Ethics application status
Submitted, not yet approved
Date submitted
19/05/2022
Date registered
23/06/2022
Date last updated
23/06/2022
Date data sharing statement initially provided
23/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A pre-post interventional study of introducing emergency department (ED)-exit pain score to improve acute pain management in older adults and evaluating its association with hospital associated complications
Scientific title
Evaluating association Between Acute Pain Management and Hospital Associated Complications in Older Adults presenting to the Emergency Department (ED) after the Introduction of Mandatory ED-exit Pain Score
Secondary ID [1] 307175 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain
 326383 0
Delirium 326384 0
Falls 326385 0
Extended hospital length of stay 326386 0
Hospital re-presentation 326387 0
Pneumonia 326388 0
Pressure sore(s) 326389 0
Condition category
Condition code
Emergency medicine 323678 323678 0 0
Other emergency care
Injuries and Accidents 323679 323679 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This research project introduces the ED-exit pain assessment. An ED Patient Safe Transfer Checklist already exists on FirstNet and this document needs to be completed prior to inpatient ward transfer or ED discharge. The checklist currently contains a section that allows clinicians to answer if the patient still remains in pain or not before their physical ED departure. FirstNet is an electronic medical records (eMR) portal used by New South Wales (NSW) Health to support various operations in EDs across the state. We will liaise with the local eMR team to mandate the ED-exit pain score and create an additional interface that allows clinicians to use appropriate pain scales based on background medical conditions (i.e. dementia) of individual patients once they have been identified to be in pain using the same form. The ED-exit pain assessment is anticipated not to take more than a few minutes (maximum of 3 minutes). The implementation of the ED-exit pain score will be supported by regular staff education, which is planned to be delivered over a period of 1 month to increase general awareness of the checklist. These short education sessions of approximately 10-minute in duration will be conducted by experienced medical and nursing staff through usual professional development channels. These sessions will typically be held in group setting three times weekly before the beginning of morning clinical shift during the compulsory staff briefing in attempt to capture as many nursing staff as possible. The ED-exit pain assessment will also be introduced during trainee teaching that is held on a weekly basis for medical staff. We predict a high compliance rate of the checklist once it becomes obligatory in routine clinical care not only in those older adults, but to all patients irrespective of their age. The compliance of the modified form will be monitored by regular checks using the eMR.
Intervention code [1] 323626 0
Early detection / Screening
Comparator / control treatment
The initial phase of the research project involves prospective data collection of randomly selected patients aged 65 years and over who meet the eligibility criteria presenting to the Royal North Shore Hospital (RNSH) ED for a period of 4 months before the introduction of the ED-exit pain score . This pre-intervention study group will be used as a control for data comparison with post-intervention group to evaluate its effectiveness in improving the quality of ED acute pain management and influence on short- and long-term patient outcomes. The data will be extracted using a standardised proforma specifically designed for the research project from hospital records with no direct participant involvement.
Control group
Active

Outcomes
Primary outcome [1] 331421 0
The number and proportion of elderly patients who had their pain assessed at the time of ED arrival and reassessed prior to ED departure along with individual pain scores by accessing the ED Patient Safe Transfer Checklists documented in electronic medical records.
Timepoint [1] 331421 0
4-5 months before and after the introduction of the ED-exit pain score on the ED Patient Safe Transfer Checklist
- at the initial ED arrival/triage
- before ED departure
- after hospital admission
Primary outcome [2] 331497 0
Identify the type, dosage and total amount of pain treatment received in the ED before and after the introduction of the ED-exit pain score by reviewing individual patient electronic medical records.
Timepoint [2] 331497 0
- at the time of ED triage
- during the entirety of ED visit
- at the time of ED departure (inpatient admission vs. ED discharge)
Primary outcome [3] 331498 0
Compare the incidence of delirium between pre- and post-intervention periods by reviewing individual patient's electronic medical records.
Timepoint [3] 331498 0
- 4-5 months before and after the introduction of the ED-exit pain score
- during the hospital admission
Secondary outcome [1] 409831 0
- the incidence of other hospital associated complications (HACS; falls, pneumonia, pressure sores) for those elderly patients admitted to the hospital before and after the introduction of the ED-exit pain score by reviewing electronic medical records
Timepoint [1] 409831 0
4-5 months before and after the implementation of the ED-exit pain score and staff education
- for the duration of ED stay
- after hospital admission
Secondary outcome [2] 410077 0
- the incidence of the aforementioned HACS of those patients who have had their pain adequately or inadequately treated by reviewing electronic medical records
Timepoint [2] 410077 0
4 months before and after the implementation of the ED-exit pain score
- during hospital admission
Secondary outcome [3] 410078 0
- Determine differences, if any, in hospital length of stay (LOS) by assessing electronic medical records before and after the ED-exit pain score is introduced
Timepoint [3] 410078 0
4 months before and after the implementation of the ED-exit pain score
- after hospital and/or ED discharge
Secondary outcome [4] 410745 0
- Determine differences, if any, in the number of hospital re-presentation by assessing electronic medical records before and after the ED-exit pain score is introduced
Timepoint [4] 410745 0
4 months before and after the implementation of the ED-exit pain score
- after hospital and/or ED discharge
Secondary outcome [5] 410746 0
- Determine differences, if any, in the incidence of mortality before and after the ED-exit pain score is introduced by assessing electronic medical records
Timepoint [5] 410746 0
4 months before and after the implementation of the ED-exit pain score
- after hospital and/or ED discharge
- follow up of up to 3 months after hospital and/or ED discharge for mortality

Eligibility
Key inclusion criteria
• Patients aged greater than or equal to 65 years presenting with pain (sources all inclusive – abdominal, musculoskeletal, non-cardiac chest pain)
• Not requiring operative intervention
• If admitted to the hospital, minimum LOS greater than or equal to 48 hours
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients under the age of 65 years
• Headache, cardiac chest pain
• Hospital LOS less than or equal to 48 hours
• Medically unstable patients requiring admission to intensive or palliative care units
• Concurrent ED presentation with delirium (hypo- and/or hyperactive)
• History of psychiatric disorders
• History of chronic pain on long-term (greater than or equal to 3 months) use of opioid analgesics

Study design
Purpose of the study
Diagnosis
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
- those patients who have had their pain adequately treated will be defined by a reduction of raw numeric pain score of greater than or equal to 2 and/or greater than or equal to 33% by percentage compared with their initial pain score at the time of the ED triage/presentation

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2022
Actual
Date of last participant enrolment
Anticipated
1/06/2025
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
708
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 311478 0
Government body
Name [1] 311478 0
Northern Sydney Local Health District
Country [1] 311478 0
Australia
Primary sponsor type
Hospital
Name
Royal North Shore Hospital Emergency Department
Address
Royal North Shore Hospital
1 Reserve Rd
St Leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 312876 0
None
Name [1] 312876 0
Address [1] 312876 0
Country [1] 312876 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310942 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 310942 0
Ethics committee country [1] 310942 0
Australia
Date submitted for ethics approval [1] 310942 0
17/06/2022
Approval date [1] 310942 0
Ethics approval number [1] 310942 0

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

Contacts
Principal investigator
Name 119438 0
Dr Min Young Park
Address 119438 0
Emergency Department
Royal North Shore Hospital
Reserve Road, St Leonards NSW 2065
Country 119438 0
Australia
Phone 119438 0
+61 2 9463 2200
Fax 119438 0
Email 119438 0
[email protected]
Contact person for public queries
Name 119439 0
Min Young Park
Address 119439 0
Emergency Department
Royal North Shore Hospital
Reserve Road, St Leonards NSW 2065
Country 119439 0
Australia
Phone 119439 0
+61 2 9463 2200
Fax 119439 0
Email 119439 0
[email protected]
Contact person for scientific queries
Name 119440 0
Min Young Park
Address 119440 0
Emergency Department
Royal North Shore Hospital
Reserve Road, St Leonards NSW 2065
Country 119440 0
Australia
Phone 119440 0
+61 2 9463 2200
Fax 119440 0
Email 119440 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


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.