Clinical trial NCT06396663: DE-eSCALation of Opioids Post-surgical dischargE
Official title: The Role of the Clinical Pharmacist in Reducing Opioid Dependence at the Interface Between Hospital and Primary Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Dependence
Keywords: Prescribing
Surgery
Pain
De-escalation
Lead sponsor: University of Kent
Sponsor class: OTHER
Collaborators: name: Kent Community Health NHS Foundation Trust
name: NHS Kent and Medway
First posted: 2024-05-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Month 3
measure: 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.
timeFrame: Month 3
measure: 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.
timeFrame: Month 3
measure: 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.
timeFrame: Month 3
measure: Determination of the barriers/enablers that affect the delivery of the intervention from the perspective of the NHS stakeholders.
timeFrame: Up to 3 months after final follow up
measure: Determination of the barriers/enablers that affect the delivery of the intervention from the perspective of the surgical patient.
timeFrame: Up to 3 months after final follow up
measure: Determination of the barriers/enablers that affect the delivery of the intervention from the perspective of the surgical patient.
timeFrame: Up to 3 months after final follow up
measure: Determination of the barriers/enablers that affect the delivery of the intervention from the perspective of the surgical patient.
timeFrame: Up to 3 months after final follow up
measure: Determination of the barriers/enablers that affect the delivery of the intervention from the perspective of the surgical patient.
timeFrame: Up to 3 months after final follow up
measure: Determination of the barriers/enablers that affect the delivery of the intervention from the perspective of the surgical patient.
timeFrame: Up to 3 months after final follow up
measure: Establishment of the cost of delivering the intervention from the health/social care provider (NHS), perspective.
timeFrame: Up to 3 months after the end of recruitment
Secondary outcomes:
measure: Determination of the percentage of participants that reduce or stop opioids in 90 days
timeFrame: Month 3
measure: Obtaining an understanding of trends in surgical opioid prescribing, surgical related pain, and risk factors that contribute to long term opioid use.
timeFrame: After the final follow up, up to 3 months
measure: Obtaining an understanding of trends in surgical opioid prescribing, surgical related pain, and risk factors that contribute to long term opioid use.
timeFrame: After the final follow up, up to 3 months
measure: Obtaining an understanding of trends in surgical opioid prescribing, surgical related pain, and risk factors that contribute to long term opioid use.
timeFrame: After the final follow up, up to 3 months
measure: Obtaining an understanding of trends in surgical opioid prescribing, surgical related pain, and risk factors that contribute to long term opioid use.
timeFrame: After the final follow up, up to 3 months
measure: Obtaining an understanding of trends in surgical opioid prescribing, surgical related pain, and risk factors that contribute to long term opioid use.
timeFrame: After the final follow up, up to 3 months
measure: Determination of the integrity, robustness, and transferability of the protocol for future adoption by the NHS.
timeFrame: Up to 3 months after final follow up
measure: Determination of the integrity, robustness, and transferability of the protocol for future adoption by the NHS.
timeFrame: Up to 3 months after final follow up
measure: Determination of the integrity, robustness, and transferability of the protocol for future adoption by the NHS.
timeFrame: Up to 3 months after final follow up
measure: Determination of the integrity, robustness, and transferability of the protocol for future adoption by the NHS.
timeFrame: Up to 3 months after final follow up
measure: Determination of the integrity, robustness, and transferability of the protocol for future adoption by the NHS.
timeFrame: Up to 3 months after final follow up
measure: Determination of the integrity, robustness, and transferability of the protocol for future adoption by the NHS.
timeFrame: Up to 3 months after final follow up
measure: Determination of the integrity, robustness, and transferability of the protocol for future adoption by the NHS.
timeFrame: Up to 3 months after final follow up
measure: Determination of the integrity, robustness, and transferability of the protocol for future adoption by the NHS.
timeFrame: Up to 3 months after final follow up
measure: Determination of the integrity, robustness, and transferability of the protocol for future adoption by the NHS.
timeFrame: Up to 3 months after final follow up
measure: Determination of the integrity, robustness, and transferability of the protocol for future adoption by the NHS.
timeFrame: Up to 3 months after final follow up
Other outcomes:
Locations:
city: Faversham
country: United Kingdom
facility: Newton Place Surgery
state: Kent
Study officials:
affiliation: University of Kent
name: Dr Emma Veale
role: PRINCIPAL_INVESTIGATOR
affiliation: Kent Community Health NHS Foundation Trust
name: Dr Johanna Theron
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.