Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000400662
Ethics application status
Approved
Date submitted
28/03/2023
Date registered
19/04/2023
Date last updated
17/04/2024
Date data sharing statement initially provided
19/04/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Understanding the pattern of pain relief medication being prescribed for patients who are discharged from the emergency department with a long-bone fracture
Scientific title
Analgesic Prescribing Practices for Patients with Long-Bone Fractures Discharged from an Emergency Department
Secondary ID [1] 309320 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
long-bone fracture 329511 0
Condition category
Condition code
Injuries and Accidents 326446 326446 0 0
Fractures

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients who present to the Emergency Department (ED) with isolated long bone fracture (humerus, clavicle, tibia, fibula, radius, ulna) will be approached for consent to participant in a follow-up telephone interview seven days following their discharge. All interviews will be conducted by a trained member of the ED research team.
The survey will take approximately 10minutes and include information regarding the type of analgesia received and/or prescribed, filling of prescriptions, other pain medications used, adequacy of pain relief within the Emergency Department and following discharge, non-pharmacological pain relief, and interference with activities of daily living and side effects.
Intervention code [1] 325754 0
Diagnosis / Prognosis
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334293 0
To investigate the impact of analgesic prescribing practices on pain scores using the 10-point Likert scale for patients with long-bone fractures discharged from the Emergency Department.
Timepoint [1] 334293 0
7 days after discharge from the Emergency Department.
Secondary outcome [1] 420160 0
To investigate opioid usage following discharge from the emergency department through telephone interview questions that ask the patient what type of pain relief they have used in the last 24 hours before the telephone interview and whether they have visited their GP for further pain relief.
Timepoint [1] 420160 0
7 days after discharge from the Emergency Department
Secondary outcome [2] 420161 0
To investigate whether patients prescribed simple analgesia will have pain that has impacted their activities of daily living through telephone interview questions that focus on whether the pain interferes with patient's activities of daily living.
Timepoint [2] 420161 0
7 days after discharge from the Emergency Department
Secondary outcome [3] 420723 0
To investigate usage of other pain medications including non-pharmacological pain relief following discharge from the emergency department through telephone interview questions that ask the patient what type of pain relief they have used in the last 24 hours before the telephone interview and whether they have visited their GP for further pain relief.
Timepoint [3] 420723 0
7 days after discharge from the Emergency Department
Secondary outcome [4] 420724 0
To investigate the adequacy of pain relief provided when patient is at the Emergency Department and following discharge through telephone interview questions that ask the patient about their level of satisfaction of their recall of the pain treatment they received while in hospital and their experiences following their discharge.
Timepoint [4] 420724 0
7 days after discharge from the Emergency Department

Eligibility
Key inclusion criteria
• Patients 17 years of age and older
• Isolated long bone fracture (humerus, clavicle, tibia, fibula, radius, ulna)
• Discharged from the Emergency Department
• Available seven days after discharge to respond to the phone questionnaire
• Written consent obtained and willingness to comply with the study
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Were admitted to hospital
• Had future planned operative management (as these patients may receive received patient controlled analgesia (PCA), pain team consultation, or other analgesia after operative fixation
• Non-English- speaking patients
• Refusal of consent
• Assessed by a member of the ED Research team to not have the capacity to independently provide informed consent

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Random sample
Timing
Prospective
Statistical methods / analysis
Demographic, clinical and procedural data were collected using a standardised case report form and entered into a computerised database. All statistical analyses will be performed using SPSS Statistics software package (IBM Corporation). Continuous variables (expressed as mean ± standard deviation) were compared using the unpaired Student’s t test, after checking the normality of data distribution with the Kolmogorov-Smirnov test and the equality of variances with the Levene test. Variables that were not normally distributed were expressed as a median with interquartile range (IQR) and comparisons were performed using the Mann-Whitney U test. Categorical data, presented as %frequency were compared using chi-square or Fisher’s exact test, as appropriate.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
15/03/2023
Date of last participant enrolment
Anticipated
15/03/2027
Actual
Date of last data collection
Anticipated
26/03/2027
Actual
Sample size
Target
100
Accrual to date
11
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 24367 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 39951 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 313516 0
Hospital
Name [1] 313516 0
Emergency Department, Royal North Shore Hospital
Country [1] 313516 0
Australia
Funding source category [2] 313641 0
Other
Name [2] 313641 0
In-kind support, Emergency Department Research Team
Country [2] 313641 0
Australia
Primary sponsor type
Hospital
Name
Emergency Department, Royal North Shore Hospital
Address
Reserve Rd, St Leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 315294 0
None
Name [1] 315294 0
Address [1] 315294 0
Country [1] 315294 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312703 0
Northern Sydney Local Health District Research Office
Ethics committee address [1] 312703 0
Ethics committee country [1] 312703 0
Australia
Date submitted for ethics approval [1] 312703 0
04/08/2022
Approval date [1] 312703 0
11/01/2023
Ethics approval number [1] 312703 0
2019/ETH00251

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

Contacts
Principal investigator
Name 125610 0
Dr Mark Gillet
Address 125610 0
Emergency Department, Royal North Shore Hospital, Reserve Rd, St Leonards NSW 2065
Country 125610 0
Australia
Phone 125610 0
+61294632228
Fax 125610 0
Email 125610 0
[email protected]
Contact person for public queries
Name 125611 0
Jennifer McGready
Address 125611 0
Emergency Department, Royal North Shore Hospital, Reserve Rd, St Leonards NSW 2065
Country 125611 0
Australia
Phone 125611 0
+61423731431
Fax 125611 0
Email 125611 0
[email protected]
Contact person for scientific queries
Name 125612 0
Mark Gillet
Address 125612 0
Emergency Department, Royal North Shore Hospital, Reserve Rd, St Leonards NSW 2065
Country 125612 0
Australia
Phone 125612 0
+61294632228
Fax 125612 0
Email 125612 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.