Protocol for a mixed methods process evaluation of the Smoking Treatment Optimisation in Pharmacies (STOP) trial

Introduction Assessing the fidelity of complex behavioural interventions and examining the contextual reasons why such interventions succeed, or fail are important activities but challenging and rarely reported. The Smoking Treatment Optimisation in Pharmacies (STOP) trial is a cluster randomised trial evaluating the effectiveness of a complex intervention to optimise the National Health Service (NHS) Stop Smoking Service delivered in community pharmacies. This complex intervention comprises a training package for pharmacy staff involving motivational interviewing and communication skills aimed at increasing smoking cessation knowledge and proactive client engagement. We report on a process evaluation which was planned alongside the trial to offer findings that will assist in the interpretation of the main trial results and help inform potential implementation in community pharmacy settings on a wider scale. Methods and analysis Quantitative data on recruitment and retention process of pharmacies, pharmacy staff and service users has been collected during the trial along with data on dose and fidelity of the intervention delivery from participating intervention arm pharmacies to identify potential implementation issues. Simulated client data on behaviour change skills and display of intervention materials from both control and intervention pharmacies is being assessed. These data will be combined with qualitative data; including adviser-smoker consultation recordings that provide a snapshot of behaviour skills delivery by stop smoking advisers and semi-structured interviews with pharmacy staff and services users from the intervention arm. Discussion Published protocols for process evaluations of complex health interventions are still rare despite increasing funding for this work to facilitate understanding of trial outcomes from an implementation perspective. This mixed methods protocol will contribute to the developing literature around the conduct of process evaluation and the value they add to health services research. Trial registration number [ISRCTN16351033][1]. Strengths and limitations of this study ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial ISRCTN16351033 ### Funding Statement This study is funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research (RP-PG-0609-10181) of which RW is the chief investigator and ST is a co-investigator. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. ### Author Declarations All relevant ethical guidelines have been followed; any necessary IRB and/or ethics committee approvals have been obtained and details of the IRB/oversight body are included in the manuscript. Yes All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes The datasets used and/or analysed during the current study are available following completion of the project from the study guarantor, Professor Robert Walton, r.walton@qmul.ac.uk on reasonable request. * STOP : Smoking Treatment Optimisation in Pharmacies NHS : National Health Service BCTs : Behaviour Change Techniques CPD : Continuing Professional Development RPS : Royal Pharmaceutical Society RIAS : Roter Interaction Analysis System REC : Research Ethics Committee [1]: /external-ref?link_type=ISRCTN&access_num=ISRCTN16351033