DE-eSCALation of Opioids Post-surgical dischargE

NCT06396663 | Recruiting

• 1 other identifier: University of Kent
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The Descale Study aims 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.

Conditions

Opioid Dependence

Keywords

Prescribing; Surgery; Pain; De-escalation

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (16)

• Determination of the percentage of participants that reduce or stop opioids in 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.

  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.

  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.

  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.

  After the final follow up, up to 3 months

Study Arms (1)

Opioid de-escalation

EXPERIMENTAL

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; Other: Gradual Opioid de-escalation; Other: Continuation of opioids

Interventions

Rapid Opioid de-escalation OTHER

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

Opioid de-escalation

Gradual Opioid de-escalation OTHER

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.

Opioid de-escalation

Continuation of opioids OTHER

Continue on opioids and review in 1 weeks time.

Opioid de-escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kent: lead
• Kent Community Health NHS Foundation Trust: collaborator
• NHS Kent and Medway: collaborator

Study Sites (1)

Newton Place Surgery

Faversham, Kent, ME13 8FH, United Kingdom

RECRUITING

Related Publications (3)

• 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.

  PMID: 28403427 BACKGROUND

• 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.

  PMID: 33057368 BACKGROUND

• 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.

  PMID: 18443635 BACKGROUND

Related 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

MeSH Terms

Conditions

Opioid-Related Disorders; Pain

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr Emma Veale

  University of Kent

  PRINCIPAL INVESTIGATOR

• Dr Johanna Theron

  Kent Community Health NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Coordinator

CONTACT

+441227764000; descalestudy@kent.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: May 2, 2024
• Study Start: January 11, 2024
• Primary Completion: June 1, 2024
• Study Completion: September 1, 2024
• Last Updated: May 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)