A study protocol: A randomised controlled trial to assess the effectiveness and cost-effectiveness of iQuit, a tailored web and text message-based system to improve smoking cessation rates in primary care.

Problem

Smoking cessation advice in primary care is usually delivered by nurses and/or healthcare assistants and offers one-to-one behavioural support to patients. In 2014/2015 one-to-one support had the highest number of smokers setting a quit date, 47% of those with their primary care provider. However, although nurse-delivered behavioural support can be effective, the percentage of successful quitters was lower than in other NHS settings or specialist services.

Approach

The iQuit system (consisting of a tailored advice report and a 90 day program of automated, tailored and interactive text message support) has undergone a pilot assessment of its effectiveness to increase successful quit attempts. Although there were no significant between-group differences in 2-week point prevalence abstinence at the 8-week primary end point (primary outcome), statistically significant between-group differences were observed for self-reported 6-month prolonged abstinence (control 8.9%, iQuit 15.1%, OR: 1.81, CI: 1.09-3.01). These findings supported proceeding to this large definitive trial to establish the effectiveness and cost-effectiveness of the iQuit System.We are undertaking a two parallel-group randomized controlled trial with 1:1 individual allocation comparing usual care (Control) with usual care plus the iQuit system (Intervention). 1452 participants will be recruited from approximately 66 GP practices (each of whom delivers smoking cessation services as part of their routine care) from the East of England. To be eligible to take part, participants must have smoked at least one cigarette within the preceding 7 days of their appointment, be willing to set a quit date, be 18 years and over and own a mobile phone capable of sending and receiving text messages. All smoking advisors receive training in study procedures and the iQuit system. Follow-up is 6 months post quit date and the primary outcome measure is 6 month prolonged abstinence biochemically validated.

Findings

To date we have recruited and trained 39 GP Practices and recruited approximately 20% of our target. The mean age of participants recruited is 48.5 (range 18-86; SD 13.6). 44% are male and the Index of Multiple Deprivation (IMD) indicates that 52 % are in the lower, i.e. more deprived , half of the IMD spectrum, (mean individual IMD score is 19.5 (range 1.99 – 70.58; SD=12.1)). 2015/2016 statistics on NHS Stop Smoking Services indicate that more women than men and more smokers under the age of 44 are setting quit dates. Our cohort currently reflects the gender rates but have more over 45’s setting quit dates.

Consequences

If shown to be cost-effective, the intervention could be relatively easily implemented in routine primary care, improving the support the NHS provides to smokers and helping thousands to quit smoking every year and consequently reduce smoking-related disease.