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Developing and testing approaches to support primary care practices to reduce harmful opioid prescribing (Opioid SMART)

Adapting and evaluating a complex adaptable intervention to reduce opioid prescribing in primary care (Opioid SMART) – WP1&2

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN75352360
Enrollment
40
Registered
2025-10-08
Start date
2025-04-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid prescribing in primary care Other

Interventions

We will conduct a randomised feasibility study with a nested qualitative study, with cluster randomisation at the practice-level. We have already shown that it is feasible and acceptable to recruit pr

Sponsors

University of Leeds
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: WP1 - workshops: 1. Consents to take part in ‘World café’ stakeholder workshops and/or individual testing rounds 2. Prescribes opioid medication in primary care (clinicians), or is involved in quality improvement in primary care, or commissions services, including medicines optimisation, for primary care, or has expertise in delivering A&F and/or FF, or is a member of the Opioid SMART PPIE group WP2 – feasibility trial: 1. Practice within Yorkshire and Humber that has previously received the CROP intervention and is not located within WY-ICB 2. Not currently in receipt of other interventions that aim to reduce prescribing of opioid medication 3. Able to identify a lead clinician or quality improvement lead for the study 4. Willing to take part in a feedback facilitation event WP2 – staff interviews: 1. Healthcare staff with a prescribing or quality improvement role within the practice 2. Employed or role within the practice during the intervention delivery period

Exclusion criteria

Exclusion criteria: WP1 - workshops: 1. Unable to speak or read English 2. Unable to attend workshops or an in-person or online testing round WP2 – feasibility trial: 1. Practice providing enhanced services for drug dependency 2. Practice in lowest ICB decile for opioid prescribing WP2 – staff interviews: 1. Unable to provide written consent 2. Unable to meet in person or online for an interview

Design outcomes

Primary

MeasureTime frame
1. Time to process electronic health record (EHR) data (in hours) to identify responders and non-responders, measured at the beginning of the study and every 2 months 2. Time to delivery of facilitation event to practices, including proportion of facilitation events delivered within 4 months of delivery of first feedback report, measured between months 1 and 4 3. Duration of facilitation events and follow up calls, measured between months 1 and 4 for event and between months 3 and 7 for follow-up calls 4. Number of follow up facilitation calls delivered, measured between months 3 and 7 5. Time to delivery of facilitation calls following each feedback report delivery, measured between months 3 and 7 6. Number and roles of staff attending facilitation event, measured between months 1 and 4 7. Identification of priorities from data completed at facilitation event, measured between months 1 and 4 8. Identification of barriers at facilitation event, measured between months 1 and 4 9. Completion of an agreed action plan at facilitation event, measured between months 1 and 4 10. Evidence of discussions regarding progress made with action plan at facilitation follow-ups, measured between months 3 and 7 11. Email delivery receipts for feedback reports, measured at month one and every 2 months 12. Behaviour Change Techniques (BCTs) delivered at facilitation event and follow-up calls, measured between months 1 and 4

Secondary

MeasureTime frame
1. A&F data obtained for inclusion in feedback reports, including proportion of practices providing data at 6 months on proportion of patients prescribed opioids (per 1000 patients), collected at month 1, every 2 months, and at 6 months 2. Time taken to write report, measured at month 1 and every 2 months 3. Time to obtain routinely collected data from EHRs, measured at month 1 and every 2 months 4. Number of accesses to feedback report online repository, measured at month 1 and every 2 months 5. Time taken by practice to collect additional outcome and process data (information regarding consultations delivered), measured at month 7 6. Number of staff and roles who agree to be interviewed, measured at month 7 7. Number, length and method of consultation (face-to-face, telephone etc) and role of healthcare professionals delivering long-term opioid medication reviews, measured at month 7 8. Number of appointments for consultations regarding chronic non-cancer pain (CNCP) (where an opioid may reasonably be expected to be prescribed), measured at month 7 9. Number of referrals to musculoskeletal, orthopaedics, and pain teams following a consultation for CNCP, measured at month 7 10. Number of attendances at emergency departments or admissions to hospital with an opioid-related condition for patients taking opioid medication, measured at month 7 11. Number of patient complaints as a significant event, measured at month 7 12. Description of patient complaints as a significant event, measured at month 7 13. Fidelity of facilitation delivery from audio recordings and facilitator field notes, including behavioural change techniques delivered as intended, measured between months 1 and 4 14. Qualitative interviews with practice staff at month 7

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 10, 2026