DE-eSCALation of Opioids Post-surgical dischargE (DESCALE)

The Role of the Clinical Pharmacist in Reducing Opioid Dependence at the Interface Between Hospital and Primary Care

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 Overview

• Status: Recruiting
• Conditions: Opioid Dependence
• Intervention / Treatment: Other: Rapid Opioid de-escalation; Other: Gradual Opioid de-escalation; Other: Continuation of opioids

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Research Coordinator; Phone Number: +441227764000; Email: descalestudy@kent.ac.uk

Study Locations

• United Kingdom
  • Kent
    • Faversham, Kent, United Kingdom, ME13 8FH
      • Recruiting
      • Newton Place Surgery
      • Contact: Research Team; Phone Number: +4401795530777 000-000-0000; Email: descalestudy@kent.ac.uk
      • Principal Investigator: Dr Short

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Other: Rapid 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; Other: Gradual 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.; Other: Continuation of opioids; Continue on opioids and review in 1 weeks time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 intervention delivery training.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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).	Up to 3 months after the end of recruitment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	After the final follow up, up to 3 months
Determination of the integrity, robustness, and transferability of the protocol for future adoption by the NHS.	Measurements of time spent finding and recruiting participants.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Up to 3 months after final follow up

Collaborators and Investigators

• Sponsor: University of Kent
• Collaborators: Kent Community Health NHS Foundation Trust; NHS Kent and Medway
• Investigators: Principal Investigator: Dr Emma Veale, University of Kent; Principal Investigator: Dr Johanna Theron, Kent Community Health NHS Foundation Trust

Publications and helpful links

General Publications

• Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21. Erratum In: JAMA Surg. 2019 Mar 1;154(3):272.
• Benyamin R, Trescot AM, Datta S, Buenaventura R, Adlaka R, Sehgal N, Glaser SE, Vallejo R. Opioid complications and side effects. Pain Physician. 2008 Mar;11(2 Suppl):S105-20.
• Jani M, Birlie Yimer B, Sheppard T, Lunt M, Dixon WG. Time trends and prescribing patterns of opioid drugs in UK primary care patients with non-cancer pain: A retrospective cohort study. PLoS Med. 2020 Oct 15;17(10):e1003270. doi: 10.1371/journal.pmed.1003270. eCollection 2020 Oct.

Helpful Links

• Public Health England, 2019. Prescribed medicines review: clinical commission group data.
• Public Health England, 2019, Dependence and withdrawal associated with some prescribed medicines.
• Office of National Statistics, 2020. Deaths related to drug poisoning in England and Wales: 2020 registrations.
• Surgery and the NHS in numbers

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2024
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: April 3, 2024
• First Submitted That Met QC Criteria: April 29, 2024
• First Posted (Actual): May 2, 2024

Study Record Updates

• Last Update Posted (Actual): May 2, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Pain; Surgery; Prescribing; De-escalation
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: University of Kent

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No