DE-eSCALation of Opioids Post-surgical dischargE

Opioid Dependence Clinical Trial

— DESCALE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06396663
• Other study ID #: University of Kent
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2024
• Est. completion date: September 2024

Study information

• Verified date: April 2024
• Source: University of Kent
• Contact: Research Coordinator
• Phone: +441227764000
• Email: descalestudy[@]kent.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Dependence
• Opioid-Related Disorders

Intervention

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
• 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.
• Continuation of opioids
Continue on opioids and review in 1 weeks time.

Locations

Country	Name	City	State
United Kingdom	Newton Place Surgery	Faversham	Kent

Sponsors (3)

Lead Sponsor	Collaborator
University of Kent	Kent Community Health NHS Foundation Trust, NHS Kent and Medway

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

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