Telephone delivered Incentives (verbal praise and small financial incentives) for encouraging individuals receiving methadone treatment to attend their pharmacy to take their medication: testing the feasibility of undertaking a future trial

Recruitment rate measured by number of patients recruited each week (of those entering opiate substitution treatment) over the 12-week recruitment period.

1. Feasibility outcomes
1.1 Rate of patients who are eligible and consent measured by percentage of screened patients who are eligible for inclusion in the feasibility trial and percentage of eligible patients who consent to participate. Data from Screening logs and Eligibility logs
1.2 Adherence to telephone text message system measured by percentage of matches between (a) daily pharmacy record and (b) record of attendance and medication compliance recorded on web-based telephone system. Data from daily pharmacy dispensing records and electronic database generated by software (this will record, due date, prescribed drug, doses and whether the patient missed their dose).
1.3 Percentage responding yes to 12 × weekly text message sent by researchers asking if they received all text message incentives or reminders for previous week (this will indicate whether they have mobile telephone and whether they are receiving text messages). Data from weekly text message received from participant
1.4 Accuracy of attendance measurement measured by percentage of matches between (a) daily pharmacy dispensing record and (b) record of attendance and medication compliance recorded in web-based software system. A ‘match’ is defined as agreement between (a) and (b) as to whether a participant attended their supervised methadone replacement appointment on a given day. Data from daily pharmacy dispensing records and electronic database generated by software (this will record, due date, prescribed drug, doses and whether the patient missed their dose.
1.5 Rates of follow-up measured by number and percentage of participants followed-up for research interview at 12 weeks post enrolment, by arm. Data from number of interviews conducted at 12 weeks post enrolment
1.6 The willingness of clusters (drug clinics and pharmacies) to be randomised measured by number and percentage of sites (drug services) enrolled relative to those approached measured by number and percentage of pharmacies enrolled relative to those approached. Data from recruitment log
1.7 Acceptability of the study to patients, drug clinic staff and pharmacists measured by qualitative views and experiences of patients, drug clinic staff and pharmacist. Data from focus groups and interviews with all participants, drug clinic staff and pharmacists at 12 weeks post
enrolment
1.8 Contextual factors and treatment processes that may impact on outcome measured by qualitative views and experiences of patients, drug clinic staff and pharmacist. Data from focus groups and interviews with all participants, drug clinic staff and pharmacists at 12 weeks post enrolment
2. Primary outcomes for exploration for a future confirmatory trial
2.1 Adherence to medication measured by 1) percentage of days (during 12 weeks post enrolment) when medication was taken; 2) Median number of days (during 12 weeks post enrolment) when medication was not taken; 3)Likert-like scale categorising participants
according to different missed dose patterns (during 12 weeks post enrolment) – percentage in each category; and 4) Number of days to missed doses outcome analysed using repeated events survival analysis. Data from daily pharmacy dispensing data sets will be authoritative data source on adherence to medication. Medication compliance recorded on software system, including patient ID, date and time, whether they attended or did not attend will be compared with pharmacy dispensing to check accuracy.
2.2 Aspects of the primary outcome measure needed for a sample size calculation for a future confirmatory trial measured by 1) Appropriate summary statistics, for example, for continuous outcomes, mean and standard deviation; 2) Estimate of the intraclass correlation for the clusters and 3) Qualitative availability and usefulness of existing pharmacy dispensing data sets. Data
from pharmacy dispensing data sets and Medication compliance recorded on software system, as above.
3. Secondary outcomes of a future confirmatory trial
3.1 Retention in treatment measured by number and percentage retained in treatment over the 12-week intervention period. Data from research interview undertaken with all participants at baseline (pre-enrolment) and at 12 weeks post enrolment
3.2 Illicit drug use measured by Opiate Treatment Index (Section 2 –Drug Use) (Validated) including: Number and percentage using illicit street drugs in past 30 days; Median number of days used illicit street drugs in past 30 days; Median number of days injected illicit street drugs use in past month; Route of use (number/percentage for each);Average cost of each drug used on average day. Data from research interview undertaken with all participants at baseline (pre enrolment) and at 12 weeks post enrolment.
3. 3. Other (health and social status) measured by
3.3.1 Alcohol Use Disorders Identification Test (AUDIT) (Validated, mean total score)
3.3.2 Hospital Anxiety and Depression Scale (HADS) (Validated, mean total anxiety and depression subscale scores); Social functioning measured using the Opiate Treatment Index (Validated, mean social functioning subscale score);
3.3.3 Physical and mental health status (Short form -36) subscale mean scores);
Data from research interview undertaken with all participants at baseline (pre enrolment) and at 12 weeks post enrolment
3.4. Socio-demographic characteristics measured by: Mean and SD of age; Number and percentage in each gender group; Number and percentage in each ethnicity group; Number and percentage in each employment status group; Number and percentage in each living situation group. Data from Research interview; undertaken with all participants at baseline (pre enrolment)
4. Outcomes for economic evaluation: Economic data collection measured by:
4.1 Resource use schedules AD-SUS (with questions about crime committed removed)
4.2 EQ -5D-5L measure of health-related-quality of life (Validated, mean utility and VAS scores and incorporated in health economic analysis)
4.3 ICECAP-A (i. Completion rates and ii. Missing data (item missing and questionnaire missing), plausible values and inconsistencies. Data from research at baseline (pre-enrolment) and at 12 weeks post enrolment.
5. Process outcomes
5.1. Determine contextual factors that impact on acceptability of intervention (including take-up and compliance) and trial procedures to both clinic and pharmacy staff and participants measured by focus groups with all participants and interviews with participating drug service staff and pharmacists at 10 weeks post enrolment.