ESCAPE RCT
Research type
Research Study
Full title
E-cigarettes for Smoking Cessation And reduction in People with mEntal illness (ESCAPE trial)
IRAS ID
328528
Contact name
Lion Shahab
Contact email
Sponsor organisation
The university of York
ISRCTN Number
ISRCTN14068059
Duration of Study in the UK
1 years, 7 months, days
Research summary
Research Summary:
The aim of our study is to assess the effectiveness and cost-effectiveness of providing an e-cigarette starter kit to people with a mental illness (PWMI) treated in the community to aid smoking cessation and harm reduction, as an adjunct to ‘usual care’.This RCT will compare the intervention (e-cigarette starter kit as an adjunct to usual care) and control groups (usual care) at 1-month and 6-month follow-up. Participants will include adults (≥ 18 years) currently receiving treatment for a mental illness in secondary or, depending on availability, primary care. The target sample size for the RCT is 616, with 308 participants allocated to each group. Participants will be randomized to either the treatment or control group. Both groups will receive brief advice to stop smoking. In addition, the treatment group will be offered a DOT PRO e-cigarette starter kit (www.liberty-flights.co.uk/DOT-PRO/DOT-PRO-Vape-Kit/), compliant with EU regulation, and an information leaflet about e-cigarettes, in addition to usual care. The primary clinical outcome measure, continuous abstinence, will be assessed at 1 and 6 months, verified by a CO reading below 10 ppm at 6-month follow-up. Secondary outcomes include changes in cigarette consumption, in mental and physical health indices, incidence of adverse events, and cost effectiveness of the intervention.
Lay summary of study results: Background and aims Smoking cigarettes remains a major health problem. People with mental health diagnoses are more likely to smoke cigarettes than people without mental health diagnoses and often do not receive the support needed to stop smoking. The ‘E-cigarettes for Smoking Cessation And reduction in People with mEntal illness’ (ESCAPE) study aimed to assess whether providing an electronic cigarette starter kit was more helpful than standard advice for people who smoked cigarettes, had a mental health diagnosis and who wanted to reduce or stop smoking cigarettes.
Project design Adults who smoked and had a mental health diagnosis were recruited from NHS Trusts and primary care (GP practices) across England between March and December 2024. In total, 95 people were enrolled in this research (participants). Participants were randomly divided into two groups, using a computer programme. The people in one group (intervention) received the e-cigarette starter kit along with a leaflet with advice and information about using e-cigarettes; 48 people were included in this group. The second group of people (control) did not receive the starter kit or information leaflet, 47 people were included in this group. Participants in both groups received standard advice for reducing or stopping smoking.
Participants provided information about themselves, their smoking behaviours and mental health symptoms on three occasions: 1. when they joined the study, 2. after 1 month, and 3. after 6-months. Participants were given a £10 love2shop voucher for providing this information on each occasion. At the end of the research, the control group participants were given an e-cigarette starter kit.
Outcomes and findings We were most interested to learn whether the research participants had stopped smoking completely at the end of the research (6-months after enrolment). We found that three participants (6.25%) from the intervention group and four participants (8.51%) from the control group had quit smoking cigarettes completely. Participants did not report any substantial change in their mental health symptoms, aside from a small improvement in anxiety across both groups. We also found that 15 participants (31.3%) from the intervention group and 12 participants (25.5%) from the control group had either stopped or at least halved their cigarette consumption.
We stayed in touch with the NHS Trusts and GP practices who were enrolling participants. At the end of the study, we invited study participants and NHS staff to share their experiences. Eight participants and 13 NHS staff members were interviewed. They said that doctors and nurses often lack time to discuss research with patients, and not all sites had specialist researchers to help them with this. Some sites also began offering their patients e-cigarettes as part of their usual care, which delayed enrolling participants in ESCAPE. The research team invited more NHS Trusts and GP practices to join, but some could not enrol people due to time pressures.
Participants said that the e-cigarette information leaflet was clear and useful, and that vouchers for completing questionnaires were appreciated. They also liked receiving free e-cigarette kits and being approached by familiar healthcare staff. However, there were communication issues between the research team and some recruitment sites, and some found the questionnaires too long. Suggestions for improving future research included translating materials into other languages to reach more people and offering more nicotine strengths and e-liquid flavours in the e-cigarette packs.
Benefit to patients and the next steps As it was difficult to recruit participants into the study, we decided to stop enrolling new people earlier than planned. This means that we did not collect enough information to say whether providing e-cigarette starter kits is a good way to help people with mental health conditions to stop or reduce their smoking.REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
23/YH/0199
Date of REC Opinion
26 Oct 2023
REC opinion
Further Information Favourable Opinion