Opioid Dependence
Conditions
Keywords
Prescribing, Surgery, Pain, De-escalation
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.
Interventions
OTHERRapid Opioid de-escalation
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
OTHERGradual Opioid de-escalation
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.
OTHERContinuation of opioids
Continue on opioids and review in 1 weeks time.
Sponsors
Kent Community Health NHS Foundation Trust
NHS Kent and Medway
University of Kent
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Aged 18 years old or above. * 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.
Exclusion criteria
* Aged under 18 years of age. * Unable to provide written informed consent. * More than 90 days opioid use pre-surgery. * On \> 120 mg MME/day. * Additional surgical procedures planned during the 3-month intervention. * A history of methadone treatment. * Regularly inject opioids. * Using opioids for malignant pain. * Undergone a caesarean section. * Is pregnant\*. * Classified as vulnerable (e.g., severe dementia, severe co-existing or terminal medical condition). * Risk of miscarriage or stillbirth from opioid withdrawal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 completed intervention delivery training. |
| 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 number of participants that enrol in the study. |
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Collect medication use data at baseline and at all follow-up appointments. |
| Determination of the integrity, robustness, and transferability of the protocol for future adoption by the NHS. | Up to 3 months after final follow up | Measurements of time spent finding and recruiting participants. |
| 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. |
Countries
United Kingdom
Contacts
Primary ContactResearch Coordinator
Outcome results
None listed