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Implementation Science
Published in: Implementation Science 1/2015

Open Access 01-12-2016 | Study protocol

A multidimensional approach to assessing intervention fidelity in a process evaluation of audit and feedback interventions to reduce unnecessary blood transfusions: a study protocol

Authors: Fabiana Lorencatto, Natalie J. Gould, Stephen A. McIntyre, Camilla During, Jon Bird, Rebecca Walwyn, Robert Cicero, Liz Glidewell, Suzanne Hartley, Simon J. Stanworth, Robbie Foy, Jeremy M. Grimshaw, Susan Michie, Jill J. Francis, for the AFFINITIE programme

Published in: Implementation Science | Issue 1/2015

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Abstract

Background

In England, NHS Blood and Transplant conducts national audits of transfusion and provides feedback to hospitals to promote evidence-based practice. Audits demonstrate 20% of transfusions fall outside guidelines. The AFFINITIE programme (Development & Evaluation of Audit and Feedback INterventions to Increase evidence-based Transfusion practIcE) involves two linked, 2×2 factorial, cluster-randomised trials, each evaluating two theoretically-enhanced audit and feedback interventions to reduce unnecessary blood transfusions in UK hospitals. The first intervention concerns the content/format of feedback reports. The second aims to support hospital transfusion staff to plan their response to feedback and includes a web-based toolkit and telephone support. Interpretation of trials is enhanced by comprehensively assessing intervention fidelity. However, reviews demonstrate fidelity evaluations are often limited, typically only assessing whether interventions were delivered as intended. This protocol presents methods for assessing fidelity across five dimensions proposed by the Behaviour Change Consortium fidelity framework, including intervention designer-, provider- and recipient-levels.

Methods

(1) Design: Intervention content will be specified in intervention manuals in terms of component behaviour change techniques (BCTs). Treatment differentiation will be examined by comparing BCTs across intervention/standard practice, noting the proportion of unique/convergent BCTs. (2) Training: draft feedback reports and audio-recorded role-play telephone support scenarios will be content analysed to assess intervention providers’ competence to deliver manual-specified BCTs. (3) Delivery: intervention materials (feedback reports, toolkit) and audio-recorded telephone support session transcripts will be content analysed to assess actual delivery of manual-specified BCTs during the intervention period. (4) Receipt and (5) enactment: questionnaires, semi-structured interviews based on the Theoretical Domains Framework, and objective web-analytics data (report downloads, toolkit usage patterns) will be analysed to assess hospital transfusion staff exposure to, understanding and enactment of the interventions, and to identify contextual barriers/enablers to implementation. Associations between observed fidelity and trial outcomes (% unnecessary transfusions) will be examined using mediation analyses.

Discussion

If the interventions have acceptable fidelity, then results of the AFFINITIE trials can be attributed to effectiveness, or lack of effectiveness, of the interventions. Hence, this comprehensive assessment of fidelity will be used to interpret trial findings. These methods may inform fidelity assessments in future trials.

Trial registration

ISRCTN 15490813. Registered 11/03/2015
Appendix
Available only for authorised users
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Metadata
Title
A multidimensional approach to assessing intervention fidelity in a process evaluation of audit and feedback interventions to reduce unnecessary blood transfusions: a study protocol
Authors
Fabiana Lorencatto
Natalie J. Gould
Stephen A. McIntyre
Camilla During
Jon Bird
Rebecca Walwyn
Robert Cicero
Liz Glidewell
Suzanne Hartley
Simon J. Stanworth
Robbie Foy
Jeremy M. Grimshaw
Susan Michie
Jill J. Francis
for the AFFINITIE programme
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Implementation Science / Issue 1/2015
Electronic ISSN: 1748-5908
DOI
https://doi.org/10.1186/s13012-016-0528-x

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