DE-eSCALation of Opioids Post-surgical dischargE
- Conditions
- Opioid Dependence
- Interventions
- Other: Rapid Opioid de-escalationOther: Gradual Opioid de-escalationOther: Continuation of opioids
- Registration Number
- NCT06396663
- Lead Sponsor
- University of Kent
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
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Aged 18 years old or above.
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Undergone surgery and discharged with opioid medication* less than 120mg MME/day from a participating hospital and taking it for the treatment of acute non-malignant post-surgical pain.
- Investigators have used the British National Formulary (BNF) definition of opioids and will recruit participants who have been prescribed one or more of the following drugs: Codeine, Dihydrocodeine, Buprenorphine transdermal patches, Fentanyl transdermal patches, Morphine, Oxycodone, Tramadol, Diamorphine, Dipipanone, Tapentadol, Pentazocine.
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Aged under 18 years of age.
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Unable to provide written informed consent.
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More than 90 days opioid use pre-surgery.
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On > 120 mg MME/day.
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Additional surgical procedures planned during the 3-month intervention.
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A history of methadone treatment.
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Regularly inject opioids.
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Using opioids for malignant pain.
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Undergone a caesarean section.
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Is pregnant*.
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Classified as vulnerable (e.g., severe dementia, severe co-existing or terminal medical condition).
- Risk of miscarriage or stillbirth from opioid withdrawal
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Opioid de-escalation Continuation of opioids An early opioid deprescribing intervention, delivered by clinical pharmacists, targeting surgical patients discharged from one-of-three East Kent University Foundation Trust hospitals, with opioids. Opioid de-escalation Rapid Opioid de-escalation An early opioid deprescribing intervention, delivered by clinical pharmacists, targeting surgical patients discharged from one-of-three East Kent University Foundation Trust hospitals, with opioids. Opioid de-escalation Gradual Opioid de-escalation An early opioid deprescribing intervention, delivered by clinical pharmacists, targeting surgical patients discharged from one-of-three East Kent University Foundation Trust hospitals, with opioids.
- Primary Outcome Measures
Name Time Method Determination of the barriers/enablers that affect the delivery of the intervention from the perspective of the NHS stakeholders. Up to 3 months after final follow up 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.
Determination of the barriers/enablers that affect the delivery of the intervention from the perspective of the surgical patient. Up to 3 months after final follow up Ascertain participant satisfaction of the intervention by measuring the responses to participant interviews.
Establishment of the cost of delivering the intervention from the health/social care provider (NHS), perspective. Up to 3 months after the end of recruitment 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).
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. Month 3 Measure the capabilities of trained clinical pharmacists to deliver an early opioid medication review by the number of participants successfully deescalated.
- Secondary Outcome Measures
Name Time Method Determination of the integrity, robustness, and transferability of the protocol for future adoption by the NHS. Up to 3 months after final follow up Number of participants that require additional support post-90 days.
Obtaining an understanding of trends in surgical opioid prescribing, surgical related pain, and risk factors that contribute to long term opioid use. After the final follow up, up to 3 months Response to Quality-Of-Life questionnaire (The EuroQol-5 Dimension (EQ5D-5L)) complete at baseline and final appointment.
Determination of the percentage of participants that reduce or stop opioids in 90 days Month 3 Measurement of the mean difference in morphine milligram equivalent (MME) dose at baseline and at 90 days.
Trial Locations
- Locations (1)
Newton Place Surgery
🇬🇧Faversham, Kent, United Kingdom