Adapted motivational interviewing for brief healthcare consultations: protocol for a systematic review and meta-analysis of treatment fidelity in real-world evaluations of behaviour change counselling

INTRODUCTION: Treatment fidelity is an important and often neglected component of complex behaviour change research. It is central to understanding treatment effects, especially for evaluations conducted outside of highly controlled research settings. Ensuring that promising interventions can be delivered adequately (ie, with fidelity) by real-world clinicians within real-world settings is an essential step in developing interventions that are both effective and ‘implementable’. Whether this is the case for behaviour change counselling, a complex intervention developed specifically for maximising the effectiveness of real-world consultations about health behaviour change, remains unclear. To improve our understanding of treatment effects, best practice guidelines recommend the use of strategies to enhance, monitor and evaluate what clinicians deliver during patient consultations. There has yet to be a systematic evaluation of whether and how these recommendations have been employed within evaluations of behaviour change counselling, nor the impact on patient health behaviour and/or outcome. We seek to address this gap. METHODS AND ANALYSIS: Methods are informed by published guidelines. Ten electronic databases (Medline, PubMed, EMBASE, PsycINFO, CINAHL Complete, ScienceDirect, Taylor and Francis; Wiley, ProQuest and Open Grey) will be searched for published and unpublished articles that evaluate behaviour change counselling within real-world clinical settings (randomised and non-randomised). Eligible papers will be rated against the National Institute of Health fidelity framework. A synthesis, evaluation and critical overview of fidelity practices will be reported and linear regression used to explore change across time. Random-effect meta-regression is planned to explore whether fidelity (outcomes reported and methods used) is associated with the impact of behaviour change counselling. Standardised effect sizes will be calculated using Hedges’ g (continuous outcomes) and ORs (binary/dichotomous outcomes). ETHICS AND DISSEMINATION: No ethical issues are foreseen. Findings will be disseminated via journal publication and conference presentation(s). PROSPERO REGISTRATION NUMBER: CRD42019131169