Strategies to recruit hard-to-reach smokers into Exercise Assisted Reduction then Stop (EARS): a pragmatic pilot randomised trial

Abstract

BackgroundHelping smokers from disadvantaged backgrounds to reduce their smoking could result in more quit attempts and successful quitting, which in turn could help to tackle health inequalities. No study has assessed the effects of exercise counselling (delivered by health trainers) on smoking reduction and quitting, among hard-to-reach smokers. We aimed to assess recruitment methods in a trial targeting hard-to-reach smokers who wished to reduce but not quit smoking, without using nicotine replacement therapy. MethodsThe Exercise Assisted Reduction then Stop (EARS) pilot randomised trial was set up to examine the feasibility and acceptability of trial methods and 8-week intervention, with follow-up assessments up to 16 weeks, and primary outcome being 4-week post-quit abstinence confirmed by expired air CO. Patients were allocated to treatment or usual care (advice to quit) with a password protected web-based randomisation system set up and managed by the UK Clinical Research Collaboration's accredited Peninsula Clinical Trials Unit. Randomisation was 1:1 and minimised by age, sex, health trainer (one of three), and smoking dependence level. To maintain concealment, the minimisation algorithm retained a stochastic element. Follow-up assessments were done by a researcher who also provided the intervention (for those receiving exercise assisted reduction), and were therefore not masked to treatment. This method was used to maximise data collection within a hard-to-reach population. We focused recruitment on individuals from two socially deprived wards in Plymouth (ie, in the top 3% most deprived areas in England). Three main approaches were tested: invitation letter (and reminder note plus phone calls) to known smokers without contraindications to do moderate physical activity, through (1) primary care, or (2) stop smoking services (SSS; targeting failed quitters in the previous 2 years); or (3) other community-based approaches such as audio and written media, posters, third-sector networking (eg, housing trusts), opportunistic recruitment (eg, outside job centre), workplaces with high proportion of low-skilled employees, and attending local events and centres. We compared recruitment rates through each of the three settings. For non-normally distributed data we present medians and IQRs. FindingsWe recruited 99 smokers (between May, 2011, and May, 2012), of whom 46 (46%) were unemployed and 45 (45%) in social class C2–E, and 41 (41%) were moderately or extremely anxious or depressed (from item 5 of EQ-5D). The sample had a mean age of 47·2 years (SD 11·3), median school leaving age of 16·0 years (IQR 15·0–16·0), initial smoking age of 14 years (13·0–16·0) years, equivalent cigarettes smoked per day of 19·1 (14·4–24·4), and a mean Fagerstrom test for nicotine dependence score of 5·6 (SD 2·1). Recruitment resulting from invitation letters from GPs and SSS were similar and ranged from 5·1–11·1% depending on the effort invested in follow-up phone calls. Overall, 62 (63%) participants were randomly assigned from GP invitations and 31 (31%) from SSS invitations. Despite substantial effort, only six (6%) of the total sample were recruited via other community approaches. Those recruited via primary care and SSS did not differ in any background variable, and we had insufficient data from other community approaches for comparison. InterpretationWe matched our targets for recruiting hard-to-reach smokers into a randomised trial, and identified the probable recruitment rates for three different approaches. The most effective approach was by mailed invitation letter, with follow-up phone calls roughly doubling the recruitment rate, but with considerable additional effort. Data captured in the pilot study will establish whether recruitment approach was related to study retention and effects of the intervention. FundingNational Institute for Health Research (Health Technology Assessment) in the UK, SmokeFree South West, and Plymouth Primary Care Trust.