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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12621000919819
Ethics application status
Approved
Date submitted
8/06/2021
Date registered
15/07/2021
Date last updated
7/10/2023
Date data sharing statement initially provided
15/07/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
Responsible opioid use before hip and knee replacement surgery
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Scientific title
Feasibility of responsible pre-operative opioid use for Hip and knee ArthropLasTy (OpioidHALT) pilot study
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Secondary ID [1]
303894
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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:
opioid use
321533
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total knee arthroplasty
321534
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total hip arthroplasty
321535
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Condition category
Condition code
Anaesthesiology
319285
319285
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0
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Pain management
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
OpioidHALT:
This will be a randomised controlled pilot study to establish the feasibility and acceptability of an intervention on the preoperative reduction of opioid use before elective THA or TKA compared to usual practice. Participants will be randomised in a 1:1 ratio to: (1) pharmacist tele-health consultation to individualise pain management and opioid tapering plans; or (2) usual care (Control).
Intervention - Pharmacist-led opioid tapering:
A pharmacist will contact the patient's General Practitioner (GP) by telephone to outline the intervention and address any concerns raised. With the GP’s approval for his/her patient to participate in the trial, the pharmacist will proceed to contact the participant.
Participants will receive tele-health consultations with a Home Medicines Review accredited pharmacist. Pharmacist consultations will be based off the Behaviour Change Wheel for behaviour change interventions. The pharmacist will complete a pain management plan and an opioid weaning plan with the patient. We will use the pain management plan from NPS Medicinewise Australia, which will be tailored to the individual. A pharmacist trained in pain self-management will provide education on the development of pain self-management skills such as participating in physical exercise, learning relaxation techniques and implementing sleep hygiene practices. Necessary referrals to other health care professionals, such as physiotherapists, will be communicated to the patient’s GP to coordinate the patient’s care. The NPS opioid weaning plan will be used and involves an individualised tapering rate of 10-25% of the original opioid dose per week for patients on opioids for less than three months. Patients taking opioids for three or more months will taper opioids at a rate of 10-25% of the original opioid dose per month. The rate and end-point of opioid tapering will be guided by the pharmacist but will be patient-led, and individualised for dose, length of use and patient circumstances. The pharmacist will educate the patient on specific steps for the management of potential opioid withdrawal effects or increased pain. For example, if withdrawal effects are experienced, the patient will be instructed to pause tapering their opioid dose. If pain is experienced, the patient will be instructed to employ pain self-management strategies. If these effects persist, the patient will be instructed to increase their opioid dose. If withdrawal effects or pain persist beyond this, the patient will be instructed to see their GP. The completed pain management plan and opioid tapering plan will be reviewed by an Anaesthetist to ensure safety and effectiveness before they are sent to the patient’s GP to ensure continuity of care. Patients will receive follow-up appointments with the pharmacist one week after each opioid dose reduction to review tapering progress, address any difficulties encountered and adjust the opioid tapering plan as required. Opioid dose reduction will continue until a target of > 50% of the original daily opioid dose is tapered and the patient is clinically stable, without experiencing physical or psychological discomfort.
The intervention will be administered a minimum of 3 and maximum of 12 months before surgery. Each telehealth consultation will be administered as at least 4 weekly sessions. Each session will approximately be 30 minutes in duration. Patients will receive a minimum of 3 sessions over approximately 3 months. Adherence to the intervention will be monitored using session attendance checklists and standard documentation forms. If the intervention ends before the patient is due for surgery, the patient will be asked to continue tapering their opioid dose with their GP using the given plans until the day of surgery.
Patients who are ineligible for participation in the trial due to attendance at a pain clinic or those who are eligible but decline participation in the randomised trial will be invited to join an observation group. From the observation group, we will collect data by telephone at 3 months before surgery, 1 to 3 days before surgery, as well as information related to hospital stay upon hospital discharge from the electronic health record as outlined above. Patients will be offered a $50 gift card by email or by postage per telephone interview in return for their time. The value of the Observational arm is to provide a snapshot of opioid use of patients currently being managed by pain clinics. We will be able to see if opioid use among such patients increases or decreases whilst under the care of the clinic, thus providing indirect evidence of the need for an alternative intervention to help lower opioid use. In addition, there is a possibility we will recruit the people most keen to wean off their medications. By capturing data and following those who are eligible but are reluctant to participate in the randomize trial, we can compare whether those who refused have different characteristics to those who agree, and also obtain information about whether people are self-weaning or, conversely, actually increasing their opioid intake, and what happens to them.
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Intervention code [1]
320250
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Behaviour
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Comparator / control treatment
Control - Usual care:
Usual care will serve as the control condition. Participants will continue to be contacted and reviewed by health professionals during preadmission clinics as required while awaiting Arthroplasty. Health professionals may provide patients with non-pharmacological pain management advice.
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Control group
Active
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Outcomes
Primary outcome [1]
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The proportion of patients weaned by at least 50% of their daily opioid dose before surgery assessed by audit of study records
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Assessment method [1]
327163
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Timepoint [1]
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At trial conclusion
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Primary outcome [2]
327164
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The proportion of eligible patients recruited per month assessed by audit of study records
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Assessment method [2]
327164
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Timepoint [2]
327164
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At trial conclusion
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Primary outcome [3]
327165
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Retention of participants in both arms of the study assessed by audit of study records
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Assessment method [3]
327165
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Timepoint [3]
327165
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At trial conclusion
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Secondary outcome [1]
394022
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The number of patients recruited per month assessed by audit of study records
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Assessment method [1]
394022
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Timepoint [1]
394022
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At trial conclusion
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Secondary outcome [2]
394023
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The proportion of patients taking low (less than 60 mg morphine milligram equivalents) or high doses (greater than or equal to 60 mg morphine milligram equivalents) of opioids per day before surgery assessed by audit of study records [composite secondary outcome]
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Assessment method [2]
394023
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Timepoint [2]
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At trial conclusion
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Secondary outcome [3]
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Length of hospital stay assessed by collecting data from patient medical records.
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Assessment method [3]
394024
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Timepoint [3]
394024
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On the day of hospital discharge
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Secondary outcome [4]
394025
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30-day hospital readmission rate assessed by collecting data from patient medical records.
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Assessment method [4]
394025
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Timepoint [4]
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30 days after hospital discharge
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Secondary outcome [5]
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90-day hospital readmission rate assessed by collecting data from patient medical records.
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Assessment method [5]
394026
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Timepoint [5]
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90 days after hospital discharge
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Secondary outcome [6]
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Patient-reported health-related quality of life using the Patient-Reported Outcomes Measurement Information System (PROMIS-29)
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Assessment method [6]
394027
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Timepoint [6]
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1 to 3 days before surgery and 90 days after hospital discharge.
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Secondary outcome [7]
394028
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Index joint pain using 11 point numeric rating scale
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Assessment method [7]
394028
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Timepoint [7]
394028
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1 to 3 days before surgery and 90 days after hospital discharge.
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Secondary outcome [8]
394029
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Total body pain using 11 point numeric rating scale
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Assessment method [8]
394029
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Timepoint [8]
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1 to 3 days before surgery and 90 days after hospital discharge.
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Secondary outcome [9]
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Physical function using Patient-Reported Outcomes Measurement Information System (PROMIS-29)
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Assessment method [9]
394030
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Timepoint [9]
394030
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1 to 3 days before surgery and 90 days after hospital discharge.
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Secondary outcome [10]
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Analgesic and benzodiazepine use assessed by collecting data from patient medical records.
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Assessment method [10]
394031
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Timepoint [10]
394031
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1 to 3 days before surgery and 90 days after hospital discharge.
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Secondary outcome [11]
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Proportion of patients using opioids regularly (every day), assessed by audit of study records
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Assessment method [11]
394032
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Timepoint [11]
394032
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1 to 3 days before surgery and 90 days after hospital discharge.
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Secondary outcome [12]
394033
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Incidence of opioid-related adverse events such as constipation, falls or sedation; assessed by audit of study records
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Assessment method [12]
394033
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Timepoint [12]
394033
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1 to 3 days before surgery and 90 days after hospital discharge.
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Secondary outcome [13]
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Pain catastrophising assessed using the Pain Catastrophising Tool
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Assessment method [13]
405695
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Timepoint [13]
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1 to 3 days before surgery and 90 days after hospital discharge
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Secondary outcome [14]
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Incidence of opioid withdrawal assessed using the Short Opioid Withdrawal Scale
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Assessment method [14]
405696
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Timepoint [14]
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1 to 3 days before surgery and 90 days after hospital discharge
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Secondary outcome [15]
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Complications during hospital stay assessed by collecting data from patient medical records. These complications include: major joint (deep surgical site infection, wound bleed/haemarthrosis, dehiscence, nerve injury, dislocation, intraoperative fracture); minor joint (persistent wound ooze, suspected surgical site infection, blistering); major non-joint (death, myocardial infarction, symptomatic venous thromboembolism (VTE), aspiration, chest infection, excessive non-joint bleeding.
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Assessment method [15]
405697
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Timepoint [15]
405697
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30 days after hospital discharge
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Secondary outcome [16]
405698
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Discharge destination assessed by collecting data from patient medical records (home/usual/relative residence vs. inpatient rehabilitation)
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Assessment method [16]
405698
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Timepoint [16]
405698
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30 days after hospital discharge
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Secondary outcome [17]
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Opioid Dependency using the Overuse, Worrying, Losing Interest in usual activities due to opioid medicines (OWLS) Tool.
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Assessment method [17]
405699
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Timepoint [17]
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3 months before surgery, 1-3 days before surgery and. 3 months after surgery.
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Eligibility
Key inclusion criteria
Randomised Study:
Aged 18 years or older, undergoing elective THA or TKA for osteoarthritis, speaks and reads English, uses opioid analgesics daily, has access to internet or telephone.
Observational Arm:
Aged 18 years or older, undergoing elective THA or TKA for osteoarthritis, speaks and reads English, uses opioid analgesics daily, has access to internet or telephone, attending pain clinic, under the care of a pain specialist or already undergoing opioid tapering or previously participated in an opioid tapering study.
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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
Randomised Study:
Patients undergoing repeat surgeries (same procedure within 6 months), using opioids for oncology, palliative care or substance use disorder, already undergoing or previously participated in an opioid tapering study, comorbid cognitive impairment or intellectual disability, currently attending a pain clinic or under the care of a pain specialist.
Observational Arm:
Patients undergoing repeat surgeries (same procedure within 6 months), using opioids for oncology, palliative care or substance use disorder, comorbid cognitive impairment or intellectual disability.
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
One study investigator will contact the central randomisation service by telephone each time a patient is to be randomised to allow allocation concealment.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised in a 1:1 ratio to: (1) pharmacist tele-health consultation to individualise pain management and opioid tapering plans; or (2) usual care. Randomisation will be conducted using a centralised, telephone-based randomisation service. Randomisation of participants will be stratified by hospital site.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people analysing the results/data
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Intervention assignment
Other
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Other design features
Patients who are ineligible for participation in the trial due to attendance at a pain clinic or those who are eligible but decline participation in the randomised trial will be invited to join an observation group. From the observation group, we will collect data by telephone at 3 months before surgery, 1 to 3 days before surgery, as well as information related to hospital stay upon hospital discharge from the electronic health record.
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
Primary outcome: We will detect between-group differences in the extent of opioid tapering using inferential statistics. As appropriate for detecting differences in between-group proportions, we will use the Chi-square statistic and report the risk ratio with its 95% confidence interval (CI).
Secondary clinical outcomes: Our study will not be powered to detect statistically significant differences in the secondary outcomes. We will report differences between groups for continuous outcomes as mean difference and estimated 95% CI. Nominal variables will be reported as percentage differences and estimated 95% CIs.
Feasibility outcomes: Descriptive analysis will be used to report feasibility outcomes.
Statistical analyses will be conducted on the basis of intention to treat, per-protocol and as-treated principles using SPSS Version 25 (IBM Corporation, Armonk, NY, USA) in consultation with a biostatistician.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
2/01/2022
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Actual
27/12/2021
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Date of last participant enrolment
Anticipated
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Actual
22/09/2022
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Date of last data collection
Anticipated
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Actual
30/06/2023
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Sample size
Target
60
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Accrual to date
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Final
70
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
308285
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Other Collaborative groups
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Name [1]
308285
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International Pharmaceutical Federation
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Address [1]
308285
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Andries Bickerweg 5
2517 JP The Hague
Netherlands
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Country [1]
308285
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Netherlands
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Funding source category [2]
309000
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Other
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Name [2]
309000
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AVANT Foundation
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Address [2]
309000
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NSW State Office - Level 6, Darling Park 3, 201 Sussex Street, Sydney NSW 2000 | PO Box 746 Queen Victoria Building NSW 1230
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Country [2]
309000
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Australia
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Primary sponsor type
University
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Name
The University of Sydney
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Address
Camperdown NSW 2006
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Country
Australia
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Secondary sponsor category [1]
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Government body
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Name [1]
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South Western Sydney Local Health District
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Address [1]
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South Western Sydney Local Health District Executive Office
Liverpool Hospital Eastern Campus
Scrivener Street
LIVERPOOL NSW 2170
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Country [1]
309087
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
308259
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South Western Sydney Local Health District
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Ethics committee address [1]
308259
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South Western Sydney Local Health District Executive Office Liverpool Hospital Eastern Campus Scrivener Street LIVERPOOL NSW 2170
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Ethics committee country [1]
308259
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Australia
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Date submitted for ethics approval [1]
308259
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26/02/2021
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Approval date [1]
308259
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31/03/2021
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Ethics approval number [1]
308259
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2021/ETH00343
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Summary
Brief summary
Although we like to think that morphine-type (opioid) drugs are strong painkillers that work for all types of pain, the story turns out to be more complicated. Opioids are commonly prescribed for the pain of hip and knee osteoarthritis where there is little evidence to support their effectiveness, yet there is evidence that they increase harms. Despite this risk, an estimated 24 to 39% of patients undergoing knee or hip arthroplasty use opioids regularly while waiting for surgery. Not only is pre-surgery opioid use not very effective for the pain of severe arthritis, but research has shown that regular use is related to worse pain at the time of the operation, more side effects, longer hospital stays and more complications after discharge from hospital compared to patients who don’t use opioids regularly before surgery. Hip and knee replacements are among the most common elective surgeries performed in Australia, with approximately 100,000 hip or knee replacements performed in 2019. This means approximately 30,000 people annually potentially have their joint replacement outcomes undermined by opioid use. The proposed pilot study aims to reduce these opioid-related harms by measuring whether patients are willing and able to reduce their opioid medication by at least 50% while they are on the waiting list for elective hip or knee replacement. Those patients who agree to participate will be randomised to either a usual waiting list experience or to having a pharmacist work with their General Practitioner to reduce their opioid dose very slowly. Most patients find that their pain does not increase as the doses reduce if tapering is slow and performed in partnership with the patient. Further, individualised tapering that supports the patient, provides them with information relevant to their circumstances and allows their control of the weaning phases. After the patient and pharmacist come to an agreed opioid tapering plan, an Anaesthetist will review this plan to ensure its safety and effectiveness. Whilst the aim is to measure the feasibility of a 50% taper, the patient will decide the point at which they cease to taper. Patients will receive follow-up appointments with the pharmacist one week after each opioid dose reduction. Patients already seeing a pain specialist or undergoing opioid tapering will be invited to join an observational group. This research will be performed at both metropolitan and regional teaching hospitals in NSW, in recognition of the increased community use of, and harms from, opioids in regional areas. Patients who present for surgery while taking regular opioids not only have poorer outcomes but also pose a challenge for anaesthetists and pain management teams. Thus, the proposed research has the potential to improve the perioperative experience for both the patients and their medical teams.
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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
110110
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Dr Jonathan Penm
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Address
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N371, Pharmacy and Bank Building A15
The University of Sydney, NSW, 2006
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Country
110110
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Australia
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Phone
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+61 2 8627 5806
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Fax
110110
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+61 2 9351 4391
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Email
110110
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jonathan.penm@sydney.edu.au
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Contact person for public queries
Name
110111
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Shania Liu
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Address
110111
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N372, Pharmacy and Bank Building A15
The University of Sydney, NSW, 2006
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Country
110111
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Australia
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Phone
110111
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+61 2 9351 6972
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Fax
110111
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Email
110111
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sliu9823@uni.sydney.edu.au
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Contact person for scientific queries
Name
110112
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Shania Liu
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Address
110112
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N372, Pharmacy and Bank Building A15
The University of Sydney, NSW, 2006
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Country
110112
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Australia
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Phone
110112
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+61 2 9351 6972
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Fax
110112
0
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Email
110112
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sliu9823@uni.sydney.edu.au
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
11359
Study protocol
sliu9823@uni.sydney.edu.au
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.
Download to PDF