Peer-Delivery of a Gender-Specific Smoking Cessation Intervention for Women Living in Disadvantaged Communities in Ireland We Can Quit2 (WCQ2)—A Pilot Cluster Randomized Controlled Trial

Abstract

Introduction We Can Quit” (WCQ) is community-based stop-smoking program delivered by trained community facilitators, based on the socio-ecological framework and developed using a Community-based Participatory Research approach, targeting women living in socioeconomically disadvantaged (SED) areas of Ireland. Aims and Methods The We Can Quit2 (WCQ2) pilot trial assessed the feasibility of WCQ. A pragmatic cluster randomized controlled trial with a process evaluation WCQ2, was conducted in four matched pairs of SED districts (8–10 000 women per district). Districts were independently randomized to WCQ (group support + nicotine replacement therapy), or to individual support delivered by health professionals. Participants were adult women smokers interested in quitting, who were living or working in trial districts. Recruitment of districts and 194 women in four waves (49 women per wave); retention at 12 weeks and 6 months; fidelity to intervention delivery and acceptability of trial-related processes were assessed. Validated smoking abstinence at 12-week and 6-month post-intervention was recorded, missing data assumed as continued smoking. Results Eight districts were recruited. 125/188 (66.5%) eligible women consented. The 49 women target was reached in wave4. Retention at 12 weeks was (Intervention [I]: 55.4%; Control [C]: 51.7%), at 6 months (I: 47.7%; C: 46.7%). Smoking abstinence at 12 weeks was (I: 23.1%, [95% CI: 14.5 to 34.7]; C: 13%, [95% CI: 6.9 to 24.1]). 83.8% of session activities were delivered. Trial-related processes were acceptable to facilitators. Low literacy was highlighted as a barrier for participants’ acceptability. Conclusions WCQ was feasible to deliver by trained facilitators and indicated a positive direction in abstinence rates. Low literacy will need to be addressed in a future trial design. Implications This pilot trial showed that a stop-smoking intervention tailored to a group of women smokers living in SED areas which was delivered by trained local women within their local communities was feasible. Furthermore, although not formally compared, more WCQ women were abstinent from smoking at the end of treatment. The results are relevant to enhance the design of a fully powered effectiveness trial, and provide important evidence on the barriers to deliver a tailored smoking cessation service to SED women smokers in Ireland.

A Process Evaluation of ‘We Can Quit’: a Community-Based Smoking Cessation Intervention Targeting Women From Areas of Socio-Disadvantage in Ireland

“…Even though trial measurement continued beyond this timepoint the qualitative interviews were coupled with the end of intervention delivery, therefore, we do not know how participants felt after six months. However, retention rates were almost as good at six months as they were at the end of programme delivery (at 12-weeks: 55.4%; at 6-months: 47.7%) (30).…”

“…Trial quantitative results demonstrated that recruitment of participants into the study was feasible though challenging, as it required the active involvement of community members to achieve the target number of participating women. Retention at follow up was less than expected (30). This trial was registered on 24/09/2018 with the ISRCTN registry no: 74721694.…”

“…It was based on the Socio-Ecological Model (28) and developed using a community-based participatory research approach (29). The primary quantitative results of the WCQ2 pilot study are described elsewhere (30).…”

An application of PRECIS-2 to evaluate trial design in a pilot cluster randomised controlled trial of a community-based smoking cessation intervention for women living in disadvantaged areas of Ireland

“…Results from the trial recently published [20], indicated the feasibility and overall acceptability of conducting WCQ in a community setting and constituted valuable data to enhance the design of a future DT to assess the effectiveness of a community-based smoking cessation intervention for women living in SED areas.…”

A process evaluation of ‘We Can Quit’: a community-based smoking cessation intervention targeting women from areas of socio-disadvantage in Ireland

“…It was based on the Socio-Ecological Model (SEM) [28] and developed using a community-based participatory research approach [29]. The detailed trial methodology and primary quantitative results of the WCQ2 pilot study are described elsewhere [30].…”