Pharmacist-led DE-eSCALation of opioids post-surgical dischargE (DESCALE) – A multi-centre, non-randomised, feasibility study protocol [version 3]

Background

Opioids are frequently prescribed for short-term acute pain following surgery. Used appropriately, opioids deliver extremely favourable pain relief. Used longer than 90-days, however, can result in health complications, including unintentional overdose and addiction. Globally, >40 million people are dependent on opioids and annually >100,000 die from opioid misuse. With >4.7 million surgical procedures occurring annually in the United Kingdom it is imperative that opioid-use is managed upon discharge. A declining General Practitioner (GP) workforce and increased patient numbers, however, means gaps in healthcare during transfer of care. Here we report a mixed-methods protocol to understand the feasibility, and acceptability of a clinical pharmacist (CP)-led early opioid deprescribing intervention for discharged surgical patients.

Methods

DESCALE is a multicentre, non-randomised, pragmatic feasibility study. Participants aged ≥18 years who have undergone a surgical procedure at a single NHS trust in Southeast England and discharged with opioids and without a history of long-term opioid use, cancer diagnosis or study contraindications will be offered a Medicines Use Review (MUR) within 7‒10 days of discharge. The MUR will be delivered by CPs at participating GP practices. Feasibility outcomes will focus on recruitment, fidelity of CPs to deliver the MUR, and barriers within primary care that affect delivery of the intervention, with a maximum sample size of 100. Clinical outcomes will focus on the number of participants that reduce or stop opioid use within 91 days. Prescribing, medical, surgical, and demographic data for individual participants will be collected and analysed to inform future trial design. Qualitative interviews with participants and associated healthcare professionals will explore acceptability and implementation of the intervention.

Conclusion

Data collected with respect to opioid use post-surgery, feasibility and acceptability of the intervention, patient experience and outcome data will inform the design of future research and larger clinical trials. Plain Language Summary Opioids are very strong pain killers often given to help with severe pain, such as after having surgery. Used for a short time these drugs are very good at taking away pain. When used longer than the recommended 2-4 weeks, opioids can cause more pain and become addictive or even, the risk of early death. Despite the high side effects from using opioids, the numbers of people given these drugs has risen sharply. Whilst it’s important that surgical pain is treated correctly, it is equally important that opioids are not continued for longer than is needed and is safe. Almost 5-million surgeries occur every year in the United Kingdom (UK), yet there are no national guidelines for healthcare professionals giving out opioids after surgery. This risks these sorts of drugs being used for too long by patients. In the UK, East Kent has been highlighted as a region with above average use of these drugs by patients and use for longer than is needed and safe.