None listed
Conditions
Brief summary
This randomised clinical trial aims to determine the effectiveness of a pre-operative pharmacist-partnered opioid tapering program compared with standard care for patients awaiting elective Total Hip or Knee Arthroplasty (THA or TKA) on post-operative outcomes including persistent opioid use. Eligible participants must be aged greater than or equal to 18 years; awaiting elective unilateral or bilateral THA or TKA; speak and read English; use prescription opioid analgesics at least 4 days a week; and have access to internet or telephone. The participants will be excluded if they are undergoing a repeat surgery (same procedure within 6 months), are using opioids for cancer, palliative care or substance use disorder; have previously or are currently undergoing an opioid tapering program or active medication review; or have cognitive impairment. Enrolled participants will be randomised in a 1:1 ratio in permuted blocks of 2 and 4 to: (1) intervention, or; (2) standard care. A total of 314 participants will be recruited into the study. The intervention will include a pharmacist-partnered opioid tapering program, in which a pharmacist will work with participants to reduce their opioid dose over a 3-month period before surgery. Standard care will involve review by the hospital preadmission clinic multidisciplinary team to assess medical, physical and psychological health prior to surgery, and education sessions for preoperative and postoperative care. The primary outcome assessed is persistent opioid use 3-months post-surgery. The key secondary outcome is total Western Ontario and McMaster Universities Arthritis Index [WOMAC] score. Data analysis will be performed using an estimand framework, with a generalised estimating equation model for the primary outcome from 1-3 days pre-surgery to 3 months post-surgery and a multilevel model for the main secondary outcome from baseline to 3 months after surgery.
Interventions
This will be a randomised controlled to establish the efficacy of an intervention on the preoperative reduction of opioid use before elective Total Hip Arthoplasty or Total Knee Arthoplasty 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: Pain management and opioid tapering training will be provided to pharmacists using an existing training package developed for the pilot RCT. The pharmacists will be trained at least a month before the commencement of the intervention. The anticipated duration of the training is self-directed learning of the learning package (which involves existing pain management resources developed from the OpioidHALT Pilot Study) which will last two to five hours in total. There will also be one to three one-hour training sessions. The mode of administration will be online reading of learning material and Zoom. Training will be provided by senior members of the research team who were involved in the OpioidHALT Pilot Study. Prior to opioid tapering, a pharmacist will contact the participant’s GP to outline the intervention and address any concerns. The pharmacist will engage in shared decision-making with participants to develop an individualised biopsychosocial pain management plan and an opioid weaning plan. The opioid weaning plan will be from NPS Medicinewise 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 pharmacist will engage in shared decision-making with the patient to decide upon a reduced opioid dose. Patients will receive follow-up appointments with the pharmacist one week after each opioid dose reduction. The endpoint of opioid tapering will be decided using shared decision-making and open communication with participants. Participants will receive the intervention for approximately 3 months. Each session will be approximately 30 minutes of consultation held weekly. The opioid tapering target of greater than or equal to 50% of the baseline opioid dose was chosen as this has been shown to improve post-surgical outcomes similar to opioid-naïve participants. If this target is reached before the participant is due for surgery, the participant will continue to be followed up until the day of surgery. The intervention employs key components of the Behaviour Change Wheel to target participant behaviour change by leveraging (i) capability (by improving participants’ confidence and knowledge of effective pain management and opioid tapering), (ii) opportunity (by providing an individualised pain management and opioid tapering service that is more accessible than traditional pain clinics) and (iii) motivation (by engaging with participants through shared decision making and encouraging active involvement in participants’ own health). The frequency of the intervention will be up to weekly as described above. Patients will receive the intervention for approximately 3 months. If the intervention ends before the patient is due for surgery, the patient will continue to be followed up by the study pharmacist until the day of surgery. Interventions will be delivered via telehealth (e.g., Zoom) or via a telephone call. The adherence to the intervention will be monitored by asking participants to fill out a Pain Management Plan and Opioid Tapering Plan that was developed for the OpioidHALT Pilot Study. We will also collect data on medication use before patients undergo surgery by telephone call with participants and using participant pharmacy records.
Sponsors
Study design
Eligibility
Inclusion criteria
Randomized Study: Inclusion criteria: Aged 18 years or older, undergoing elective THA or TKA for osteoarthritis, speaks and reads English, uses prescription opioid analgesics daily, and has access to the internet or telephone. Criteria for GP review: Psychological distress and suicidality will be screened using the 6-item Kessler Psychological Distress Scale (K6) and the 3-item Patient Safety Screener (PSS). Patients with: (i) a K6 score of 19 or greater AND PSS criteria 1 (feeling down, depressed, or hopeless over past two weeks); OR (ii) PSS criteria 2 (thoughts of killing yourself over past two weeks); OR (iii) PSS criteria 3 (ever attempted to kill yourself) AND report suicidality in the past 6 months will be referred to their GP to confirm whether participation in the trial is appropriate.
Exclusion criteria
Exclusion criteria: Patients undergoing planned repeat surgeries (same procedure within 6 months), using opioids for cancer, palliative care, or substance use disorder, previously or already undergoing an opioid tapering program or active medication review, and major cognitive impairment.