ESCAPE - RCT STUDY (CPMS 58155, IRAS 328528)

UPDATED - 19/04/2024

Study 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. Adults (> 18 years) receiving treatment for a mental illness in primary or secondary care, who smoke regularly and have smoked combustible cigarettes in the past 7 days) will be eligible to participate. The target sample size for the RCT is 616, with 308 participants allocated to each group. Participants will be randomised to either the treatment or control group. Both groups will receive brief advice to stop smoking. In addition, the treatment group will be offered an e-cigarette; an ICON Vape. (https://www.iconvape.com/products/icon-pod-device-vape-kit), an easy to use suction-automated e-cigarette with four weeks supply of pre-filled 1.6ml pods containing 20mg/mL nicotine e-liquid in tobacco, menthol and fruit flavours, and an information leaflet about e-cigarettes. 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, mental and physical health indices, incidence of adverse events, and cost effectiveness of the intervention.

Inclusion Criteria

Adults (> = 18 years) receiving treatment for a mental illness in primary or secondary care, who smoke regularly and have smoked combustible cigarettes in the past 7 days) will be eligible to participate. Participants must be willing to address their smoking behaviour, either by attempting to quit or by reducing their consumption and have capacity to provide consent. 

Exclusion Criteria

To reduce the possibility of hospital admission for acute events (and thus the risk of drop-out), patients must not have had an inpatient admission in the last 3 months according to their health care record. Smokers who are currently using e-cigarettes regularly (at least weekly), are participating in other smoking cessation trials, are receiving treatment for drug or alcohol use in a specialist service, have a diagnosis of Alzheimer’s disease or dementia, or are pregnant or breastfeeding will be excluded. 

Study Resources

Access for the SystmOne and EMIS study resources can be requested below.

For further guidance on using the resources, please refer to the guidance documents and further useful information on the PRIDES page.

The searches have been created with the study specific inclusion and exclusion criteria. 

If you require any further information or help, please contact the IT Specialists:

Jodie Button – jodie.button@nihr.ac.uk

James Baslington – james.baslington@nhs.net

Disclaimer:

Please note the resources provided are designed to assist with the identification of potentially suitable patients and to appropriately code these patients if required.

These resources have been developed based on the criteria provided by the relevant study team and whilst every effort has been made to make them universally implementable they rely on read codes and the data stored in the individual practice's clinical system. These resources are intended to assist with identification but should be used in conjunction with clinical oversight and a clear understanding of the study parameters.

While we endeavour to keep the information, tools and resources provided up to date and correct, we make no representations or warranties of any kind, express or implied, about the completeness, accuracy, reliability, suitability or availability with respect to the tools provided for any purpose. Any reliance you place on such information is therefore strictly at your own risk.

In no event will we be liable for any loss or damage including without limitation, indirect or consequential loss or damage, or any loss or damage whatsoever arising from loss of data or profits arising out of, or in connection with, the use of the tools provided.