The Descale Study aims to: 1. Look at the prescribing trends of opioids and the scale of long-term use following surgery within East Kent (United Kingdom) 2. Carry out a feasibility study to: * see if clinical pharmacists can support patients following surgery to manage their post-surgical pain safely and prevent long-term opioid use * calculate how much it costs the National Health Service (NHS) * see how the patients experienced the intervention For Aim 1, historic records of patients who have had surgery and were discharged on opioids will be reviewed. Data collected will include type and strength of pain-relieving medication prescribed; type of surgery; number of additional opioid prescriptions following discharge; use of medical services (e.g., General Practice appointments, physiotherapy); and patient demographics. For Aim 2, clinical pharmacists will carry out early high-risk medication safety reviews to ensure that patients have their pain managed safely. Investigators will collect key data from patients receiving the clinical pharmacist intervention to see how it affected opioid use, costs and healthcare use. Patients who took part in the study will be invited to participate in an interview and will be asked what they know about opioids and the health risks, and their experiences of the intervention.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
100
Option 1: 10% - 50% decrease/day until opioids discontinued (≤ 10 days). For Fentanyl patches in decrements of 12 mcg/hr. Option 2: Stop all opioid medication completely
Option 1: 20% - 50% decrease/weekly until opioids discontinued Option 2: 10% - 20% decrease/weekly until 30 mg daily. Then reduce by 5% - 10% everyday.
Continue on opioids and review in 1 weeks time.
Newton Place Surgery
Faversham, Kent, United Kingdom
RECRUITINGDetermination of the fidelity of an early opioid deprescribing intervention led by trained clinical pharmacists in primary care and their role in the wider medicine's optimisation programme.
Measure the capabilities of trained clinical pharmacists to deliver an early opioid medication review by completed intervention delivery training.
Time frame: Month 3
Determination of the fidelity of an early opioid deprescribing intervention led by trained clinical pharmacists in primary care and their role in the wider medicine's optimisation programme.
Measure the capabilities of trained clinical pharmacists to deliver an early opioid medication review by observational competency checks by clinical lead.
Time frame: Month 3
Determination of the fidelity of an early opioid deprescribing intervention led by trained clinical pharmacists in primary care and their role in the wider medicine's optimisation programme.
Measure the capabilities of trained clinical pharmacists to deliver an early opioid medication review by completed medication review case reports.
Time frame: Month 3
Determination of the fidelity of an early opioid deprescribing intervention led by trained clinical pharmacists in primary care and their role in the wider medicine's optimisation programme.
Measure the capabilities of trained clinical pharmacists to deliver an early opioid medication review by the number of participants successfully deescalated.
Time frame: Month 3
Determination of the barriers/enablers that affect the delivery of the intervention from the perspective of the NHS stakeholders.
Maintain detailed records of any barriers or enablers that may occur in response to setting up the intervention and whilst delivering the intervention. Captured via Stakeholder Interviews.
Time frame: Up to 3 months after final follow up
Determination of the barriers/enablers that affect the delivery of the intervention from the perspective of the surgical patient.
Ascertain participant satisfaction of the intervention by measuring the number of participants that enrol in the study.
Time frame: Up to 3 months after final follow up
Determination of the barriers/enablers that affect the delivery of the intervention from the perspective of the surgical patient.
Ascertain participant satisfaction of the intervention by measuring the number of withdrawals from the study.
Time frame: Up to 3 months after final follow up
Determination of the barriers/enablers that affect the delivery of the intervention from the perspective of the surgical patient.
Ascertain participant satisfaction of the intervention by measuring the adherence to pharmacist medication recommendations.
Time frame: Up to 3 months after final follow up
Determination of the barriers/enablers that affect the delivery of the intervention from the perspective of the surgical patient.
Ascertain participant satisfaction of the intervention by measuring the responses to participant satisfaction questionnaire.
Time frame: Up to 3 months after final follow up
Determination of the barriers/enablers that affect the delivery of the intervention from the perspective of the surgical patient.
Ascertain participant satisfaction of the intervention by measuring the responses to participant interviews.
Time frame: Up to 3 months after final follow up
Establishment of the cost of delivering the intervention from the health/social care provider (NHS), perspective.
Apply a micro-costing approach to estimate the intervention costs (combining opioid medication costs and staff costs, with Health resource use (primary care services, community-based services, hospital inpatient and outpatient services) to establish overall cost).
Time frame: Up to 3 months after the end of recruitment
Determination of the percentage of participants that reduce or stop opioids in 90 days
Measurement of the mean difference in morphine milligram equivalent (MME) dose at baseline and at 90 days.
Time frame: Month 3
Obtaining an understanding of trends in surgical opioid prescribing, surgical related pain, and risk factors that contribute to long term opioid use.
Collect medication use data at baseline and at all follow-up appointments.
Time frame: After the final follow up, up to 3 months
Obtaining an understanding of trends in surgical opioid prescribing, surgical related pain, and risk factors that contribute to long term opioid use.
Compare opioid prescribing (type, dose, amount) at baseline for each surgical speciality and hospital.
Time frame: After the final follow up, up to 3 months
Obtaining an understanding of trends in surgical opioid prescribing, surgical related pain, and risk factors that contribute to long term opioid use.
Measure pain scores at baseline and final visits.
Time frame: After the final follow up, up to 3 months
Obtaining an understanding of trends in surgical opioid prescribing, surgical related pain, and risk factors that contribute to long term opioid use.
Measurement of risk factors in the participant population that have been previously linked to long-term opioid use, from Baseline demographics and Medical, prescription and surgical histories.
Time frame: After the final follow up, up to 3 months
Obtaining an understanding of trends in surgical opioid prescribing, surgical related pain, and risk factors that contribute to long term opioid use.
Response to Quality-Of-Life questionnaire (The EuroQol-5 Dimension (EQ5D-5L)) complete at baseline and final appointment.
Time frame: After the final follow up, up to 3 months
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Determination of the integrity, robustness, and transferability of the protocol for future adoption by the NHS.
Measurements of time spent finding and recruiting participants.
Time frame: Up to 3 months after final follow up
Determination of the integrity, robustness, and transferability of the protocol for future adoption by the NHS.
Measurement of number of possible surgical participants per week that could receive intervention.
Time frame: Up to 3 months after final follow up
Determination of the integrity, robustness, and transferability of the protocol for future adoption by the NHS.
Measurement of number of pharmacists available to deliver the intervention.
Time frame: Up to 3 months after final follow up
Determination of the integrity, robustness, and transferability of the protocol for future adoption by the NHS.
Measurement of number of surgical participants that accept an early Medicines Utilisation Review versus the number that are asked.
Time frame: Up to 3 months after final follow up
Determination of the integrity, robustness, and transferability of the protocol for future adoption by the NHS.
Measurement of time taken from hospital discharge to receiving first Medicines Utilisation Review.
Time frame: Up to 3 months after final follow up
Determination of the integrity, robustness, and transferability of the protocol for future adoption by the NHS.
Average time taken for each appointment.
Time frame: Up to 3 months after final follow up
Determination of the integrity, robustness, and transferability of the protocol for future adoption by the NHS.
Average time taken to successfully deescalate opioids in surgical patients.
Time frame: Up to 3 months after final follow up
Determination of the integrity, robustness, and transferability of the protocol for future adoption by the NHS.
Number of participants that are successfully deprescribed opioids within 3 months.
Time frame: Up to 3 months after final follow up
Determination of the integrity, robustness, and transferability of the protocol for future adoption by the NHS.
Number of patients that require additional appointments with the pharmacist.
Time frame: Up to 3 months after final follow up
Determination of the integrity, robustness, and transferability of the protocol for future adoption by the NHS.
Number of participants that require additional support post-90 days.
Time frame: Up to 3 months after final follow up