E-cigarettes for Smoking Cessation And reduction in People with - PowerPoint Presentation

1. E-cigarettes for Smoking Cessation And reduction in People with mEntal illness (ESCAPE)ASH Smoking & Mental Health Conference24 April 23, LondonDr Elena Ratschen / Prof Lion ShahabUniversity of YorkElena.Ratschen@york.ac.uk

2. MethodsParticipantsAdult smokers (≥18 yrs) receiving treatment for a mental health problem willing to address smoking Exclusions included: recent inpatient admission, comorbid drug/alcohol problem, current e-cig useRecruitmentAnnual Care Programme Approach (CPA) reviews at Community Mental Health Teams (CMHTs)Annual physical health screens at CMHTsAnnual physical health screens for people with SMI at GP practices (Sheffield only)ProcedurePotentially eligible patients identified prior to review/apptMailout to potential participantsEligibility check via phone callConsenting, baseline measure, randomization and intervention provision on day of appointment

3. MethodsESCAPE interventionE-cigarette starter kit (ASPIRE Pockex), EU-compliant/non-TI product, provided for 4-weeks (mix of three flavours - Fruit, tobacco, menthol and strengths – 6ml/10ml/18ml)Behavioural: Bespoke information leaflet and in-person advice on use + VBAControl conditionCare as usual + VBADifferences by site/Trust recorded

4. Outcomes & Success CriteriaPrimary feasibility and acceptability measuresPrimary efficacy measuresSecondary outcomesRecruitment rate (success criteria = recruitment rate of 6 ppts/month per Trust)CO validated sustained 2-week abstinence rates at 5 weeks (ITT with missing = smoking)*Point prevalence (24h) abstinence (ITT with missing = smoking)Consenting rate (success criteria = ~15% of eligible participants)CO validated sustained 2-week abstinence rates at 5 weeks (complete cases)Point prevalence (24h) abstinence (complete cases)Attrition rate (success criteria = no more than a 30% attrition rate)At least a 50% reduction in cigarettesAdherence (to e-cigarette at 1-month follow-up)Change from baseline in clinical mental healthContaminationSerious Adverse events and Adverse eventsAcceptability (quant & qual)*Based on the one-side confidence interval approach, an estimated effect that is larger than zero

5. Primary Results (Phase 1)Recruitment rate Target - 6 per month per Trust Bradford: 3 per month (22 over 7 months) TEWV: 1.1 per month (8 over 7 months) Sheffield: 2.75 per month (11 over 4 months) London: 0.5 per month (2 over 4 months) Overall: 1.95 per month per TrustTarget not met

6. Recruitment chart (target vs actual)

7. Recruitment chart by Trust

8. Recruited sample* based on alpha 0.1

9. Primary Results (Phase 1)Consent/Conversion rate & attrition Target - 15%, with less than 30% attrition Bradford: 40% (57 eligible, 22 consented) / 14% (3 out of 22 lost to fu) TEWV: 10% (82 eligible, 8 consented) / 88% (7 out of 8 lost to fu) Sheffield: 18% (60 eligible, 11 consented) / 36% (4 out of 11 lost to fu) London: no data available / 100% (2 out of 2 lost to fu) Overall: 21% consenting rate, with 37% attritionOverall target partially met

10. Primary Results (Phase 1)Estimated effect size Primary – CO validated sustained 2-week abstinence rates at 5 weeks Intention-to-treat (0% control versus 9.5% experimental)Complete case analysis (0% control versus 13.3% experimental) Confidence Interval approach: powered at 80% to exclude a clinically meaningful one-sided effect (8% percent) in the event of there being no difference between groupsScaled confidence interval approach for feasibility and pilot trials95% confidence interval(-10.6% to 31.83%)(-18.7% to 41.6%)90% confidence interval(-3.1% to 25.1%)(-7.1% to 33.3%)85% confidence interval(-0.9% to 22.7%) (-3.5% to 28.2%)80% confidence interval(-0.7% to 20.9%) (-0.9%% to 28.2%) 75% confidence interval(1.9% to 19.4%) (1.1% to 26.4%) Unclear

11. Primary Results (Phase 1)Adherence & Contamination 67% of the experimental group reported use of an e-cigarette in the past month (acceptable level) 13.6% of the control group reported use of an e-cigarette in the past month (expected level)Acceptability Participants were comfortable using e-cigarettes and highly rated them in terms of size, shape, feel and branding Most (>66%) found clinician advice and leaflet useful, information easy to rememberOverall target met

12. Secondary Results (Phase 1)Efficacy

13. Secondary Results (Phase 1)Mental Health* based on alpha 0.2

14. Secondary Results (Phase 1)Serious Adverse Events None reportedAdverse Events A higher number of participants reporting in the experimental condition: Nausea Irritation Depression Restlessness Increased appetite Dry mouth and throat Wheezing

15. Quantitative analysis conclusionsNot feasible  recruitment and follow-up success criteria were not metModerate to high levels of acceptability Suggestive of a possible clinically significant effect on sustained abstinence and point prevalence abstinenceStronger evidence for an effect on a least a 50% reduction in cigarette consumptionSuggestive evidence for some impact on mental health indicesSlightly more adverse events in the experimental group

16. Qualitative analysisQualitative interviews Sample 13 participants (6 participants, 5 researchers, 2 clinicians) Procedure Thematic analysis Interviews conducted by 3 researchers Interviews lasted 30-40 minutes Transcribed by the interviewer Coded (first 2 transcripts were coded by all 3 researchers and initial coding framework decided) Results: 4 main themes: 1. Evidence of acceptability2. Improvements to the intervention3. Issues with the e-cigarette4. Improvements to materials and procedure

17. Overall sense of intervention acceptability1. Evidence of acceptability Happy with clinician appointment Positive about the support and information received at the appointment and communication with the clinician.Positive experience/feelings towards e-cigarette(s) Found the e-cigarette appealing and good quality. Receiving the e-cigarette increased their willingness to quit. Researchers and clinicians also felt that participants were generally happy with the e-cigarette and the intervention.Leaflet was useful The leaflet was useful, but participants didn’t tend to look at the leaflet again after the intervention. Researchers felt that the leaflet was comprehensive enough for participants.

18. 2. Improvements to the interventionTime pressures/not enough time Clinicians did not have time to deliver the intervention. 5 mins was not long enough to explain the e-cigarette. Researcher stepped in to do this at one Trust. At another Trust researchers received a lot of questions about the e-cigarette.More help using the e-cigarette required Participants with no e-cigarette experience require more assistance with the e-cigarette. This was also reported by 2 of the researchers. On-going support/contact important: Participants would like ongoing support between intervention and follow-up.Rejection and worry due to randomisation: Researchers, clinicians and participants mentioned a sense of rejection by those who did not receive an e-cigarette and worry about not receiving one prior to randomisation. Overall sense of intervention acceptability

19. 3. Issues with the e-cigaretteOngoing cost of e-cigarette is problematic Two participants believed that e-cigarettes are too expensive to continue after the trial ends.Difficulty using e-cigarette at home All intervention participants who were interviewed mentioned some difficulty with the e-cigarette after leaving the appointment. One researcher reported that people didn’t seem to like tobacco flavour liquid.Overall sense of intervention acceptability

20. 4. Improvements to materials and procedureUnhappy with questionnaire content and length Three participants felt that the questionnaires were too long, and one would have liked more time to complete them. Researchers also reported repetitive questions. Researcher support helpful during questionnaire completion Participants appreciated the support from the researcher. This was also mentioned in the researcher interviews, in-person assistance was often required.Clearer information should be provided by clinical staff. People outside of the team sometimes relayed incorrect information to patients and described ESCAPE as support rather than research.Initial contact preferences Phone calls were preferred over letters, people prefer to talk to the team.Overall sense of intervention acceptability

21. Intervention acceptability summaryParticipants found the communication and e-cigarette helpful and researchers and clinicians agree that patients would benefit from this support – specifically the information coming from a clinician.Participants were generally happy with the e-cigarette and leaflet.However…Underestimated time needed for delivery – takes longer than 5 minutes.Clinicians are too busy to provide the amount of support required.Participants need more support with the e-cigarette and ongoing support after the intervention.Questionnaires were long and repetitive.Required more research support than anticipated – questionnaires and calls.

22. Main barriers encountered Recruitment Attrition (in some Trusts) Intervention Content: more support on e-cigarette use needed for some Delivery: clinicians not best placed to respond to greater support needs Research processes/materials

23. Proposed mitigationIssueMitigation1 ) Some Trust sites proved unsuitable to support the study after the trial commenced (e.g., seeing patients solely in their homes, not on site; not having spaces/rooms for patients and researchers to meet; not seeing ppts regularly).Identify and enrol only Trusts/sites which can support the study (as per protocol) to enable smooth delivery of intervention and reduce attrition rate.2) Small caseloads per clinician and low numbers of new referrals: recruitment sources were exhausted quickly at some sites.Determine case load size and average number of new referrals to gauge how many clinicians per Trust should be engaged as a minimum.3) Primary care: clinician had no availability to book in trial participants for several weeks.Participating sites should be able to confirm that they can accommodate trial patients within 2-3 weeks.4) Exclusion criteria relatively restrictive, specifically regarding ‘patients currently also receiving treatment for a substance abuse disorder’.Consider revising criterion to include patients receiving treatment for drug and alcohol use, unless it is the primary diagnosis.5) Identification of participating sites was fairly opportunistic - better opportunities for recruitment, e.g., via weekly clozapine clinics, likely missed.Develop a list of criteria or requirements for Trusts to sign up to before joining the study and identify suitable sites using a checklist.6) Sites offering comprehensive smoking cessation support as standard care were excluded.Include sites irrespective of usual care standard, if other requirements to support recruitment are met (this being a pragmatic trial).7) Best recruiting Trust: 3 participants/month (original target for full RCT: 8/month over 19 months).Adjust target and increase number of Trusts involved based on an estimated recruitment rate of 3 participants/trust8) Some technical difficulties with e-cig with participants needing extra supportUse easier device (DotPro), provide additional video demonstrating use, a dedicated phone line and increase intervention time from 5 to 10 min.

24. Questions