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Abstract
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CINAHL Complete, ScienceDirect, Taylor and Francis; Wiley, ProQuest and Open Grey) will be searched for published and unpublished articles that evaluate behaviour change counselling within real-world clinical settings (randomised and non-randomised).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
- treatment fidelity
- complex intervention
- behaviour change counselling
- real world
- systematic review
- adapted motivational interviewing
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
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Footnotes
Contributors AKB is guarantor of the review. This work has been conducted in partial fulfilment of the requirements of the degree of PhD (Psychiatry). AKB led the development of the protocol and manuscript preparation in collaboration with supervisors ALB, BB, GC and corater EF. CO advised on statistical methods. All authors contributed to the conception and design of the systematic review and offered critical revisions to the manuscript. All authors have approved the final version of the manuscript. No patients and/ or public were directly consulted regarding the design and conduct of this review.
Funding AKB is the recipient of an Australian Government Research Training Program Scholarship (Fee Offset).
Competing interests None declared.
Ethics approval As no primary data collection will be undertaken, no formal ethical assessment is required.
Provenance and peer review Not commissioned; externally peer reviewed.
Patient consent for publication Not required.