DE-eSCALation of Opioids Post-surgical dischargE

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-11

Study Completion Date

2024-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Opioid Dependence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Rapid Opioid de-escalation

Intervention Type 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

Gradual Opioid de-escalation

Intervention Type 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.

Continuation of opioids

Intervention Type OTHER

Continue on opioids and review in 1 weeks time.

Interventions

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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

Intervention Type 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.

Intervention Type OTHER

Continuation of opioids

Continue on opioids and review in 1 weeks time.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes