Individuals receiving opioid agonist treatment Mental and Behavioural Disorders
Conditions
Interventions
The researchers will recruit three drug services (one or two from South London and the Maudsley NHS Foundation Trust (SLaM) and one or two from a large non-NHS service provider (Turning Point). Drug s
methadone or buprenorphine) and supervised consumption at community pharmacies. This feasibility study will use a cluster randomised design, where each drug service (and its allied community pharmacie
Sponsors
King's College London
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: The eligibility criteria for enrolling service user participants will include: 1. Receiving supervised OAT (methadone or buprenorphine) 6 days a week 2. Missed three doses of OAT and re-presenting at drug clinic for dose assessment/re-start 3. Aged =18 years at time of enrolment 4. Attending a participating pharmacy 5. Owns a mobile phone 6. Able to read English and not require the service of an interpreter 7. Willing and able to provide informed consent. The criteria for enrolling community pharmacies will include: 1. The pharmacy is currently providing supervised consumption of oral methadone or buprenorphine to the patients at the drug clinic 2. Pharmacists are willing and able to provide six days of supervised consumption of oral methadone or buprenorphine 3. The pharmacy has a consultation room on the premises or a separate designated area on the dispensing counter where participants can consume their oral methadone or buprenorphine under supervision 4. The pharmacy is willing and able to provide dispensing records for participants over the 12-week intervention period
Exclusion criteria
Exclusion criteria: Patients who cannot read English AND require the service of an interpreter to understand a brief oral description of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary feasibility outcome is the number of eligible patients enrolled per week over the 12-week recruitment period (assessed using recruitment records; pre-baseline). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of screened patients eligible for inclusion and reasons for ineligibility (assessed from screening forms; pre-baseline). 2. Percentage of eligible patients who consent to participate and reasons for refused consent (assessed from screening forms; pre-baseline) 3. Adherence to telephone system based on matches between self-login at pharmacy and dispensing records (N days where these match/N days total) (assessed from phone system database; continuously during 12-week follow-up). 4. Number/percentage attending follow-up interview (assessed at follow-up interview at 12 weeks). 5. Number/percentage of weeks on supervised consumption during 12-week intervention (assessed from phone system database over 12-week intervention period; and pharmacy records at end of intervention period). 6. Number/percentage on supervised consumption at end of 12-week intervention period (assessed from phone system database at 12 weeks; and pharmacy records at end of intervention period). 7. Number of restarts during 12-week intervention period (where a participant misses >3 appointments and needs to re-present at the clinic to restart their prescription) (assessed from phone system database and pharmacy records extracted at 12 weeks). 8. Number of days from last dose (i.e., last attendance at supervised consumption appointment) until prescription restart (assessed from phone system database and pharmacy records extracted at 12 weeks) 9. Qualitative assessment of clinician perspectives on the revised eligibility criteria (assessed via interviews at 12-14 weeks). | — |
Countries
England, United Kingdom
Outcome results
None listed