Table 1

Comprehensive fidelity framework developed by the NIH BCC (synthesised from 1, 2, 3), with the ASK fidelity protocol mapped alongside these recommendations

DomainRationaleNIH BCC recommendationsFidelity protocol within the ASK trial
Study designEnsures the study adequately tests its hypothesesSpecify the theoretical model underlying the treatments and define the ‘active ingredients’ of the treatmentTheoretical underpinnings identified and ‘active ingredients’ proposed
Conduct a pilot study to improve the treatment’s acceptability, feasibility and effectivenessPilot study conducted37
Specify the treatment dose within and across conditions and ensure this is deliveredTreatment dose set a priori and non-adherence is recorded as a protocol deviation
Plan how to monitor adherence to the protocol for therapy providersFidelity plan developed, as reported in the current study
Plan how to record protocol deviationsTraining provided to trial staff to identify protocol deviations, which are reported and recorded in REDCap
Describe the treatment(s) in a standardised manualEach treatment described in a standardised manual
Plan how to manage setbacks, eg, attrition of providersAll sites/clusters receive initial face-to-face training. Subsequent training (eg, for new staff or booster training) is delivered via video conference
TrainingWell-trained providers are more likely to follow the protocol and show increased competencyTherapy providers should a) have similar qualifications and experience, and b) ‘buy in’ to key aspects of the study (theory, randomisation, intervention)All therapy providers are qualified speech pathologists
Providers’ ‘buy in’ is not assessed
Standardise training using the same trainers and materials but accommodate differences in learning stylesTraining is centralised (provided by the trial manager) and standardised
All training is provided by one of two trainers (trial managers)
Measure skill acquisition and knowledge following trainingNot assessed in the current protocol
Develop a training plan to ensure providers maintain skills, eg, ongoing coaching and feedback, booster training sessionsBooster training is offered for providers to refresh their knowledge. This training can be accessed at any time at the request of the therapy provider
Train the providers in study design and the methodology of the study, including preventing contamination across treatment armsTraining includes study design and methodology as well as role-specific information and skills
Contamination across arms is reduced by the study design, ie, clusters of sites were randomised to one of two treatment arms
Treatment deliveryEnsures that providers deliver only the target treatment (treatment differentiation); maintain the required skills set (treatment competence) and administer the treatment as intended (treatment adherence)
Assessment of fidelity of delivery will a) drive supervision to improve/maintain provider skills and b) can be used in analytical models to investigate the relationship between treatment fidelity and outcome
Develop the willingness and confidence of providers to report protocol deviationsThis is not directly assessed within the ASK fidelity monitoring
Monitor non-specific treatment effects, eg, perceived differences in providers’ warmth and credibility, participant expectationsFidelity criteria requires therapy providers to demonstrate engagement, rapport and warmth, in line with their familiarity with the participant
Reduce differences within the same treatment, and maximise differences between treatmentsAudio-video recordings of interventions are rated by the fidelity monitor for presence/absence of essential and desirable behaviours
Following review of the video-recorded intervention session, the fidelity monitor provides written and verbal feedback and coaching to therapy providers
Ensure adherence to the treatment protocol including treatment content and prescribed doseTherapy providers receive the fidelity criteria prior to administering their first session
Booster training offered
Reduce the risk of contamination between treatmentsTherapy providers are trained in one trial intervention only, to reduce the risk of contamination
Enhance adherence to the treatment protocol by audio or video recording treatment sessionsAll treatment sessions are video recorded and a selection are reviewed by the fidelity monitor
Treatment receiptInvestigates whether the participant understood the treatment and can demonstrate knowledge of or application of the skills taught in the treatmentEnsure participants understand the information provided in the treatmentThis is not directly assessed within the ASK fidelity monitoring. However, both treatments are delivered by qualified speech pathologists who should have skills in supporting people with aphasia to get their message in (ie, comprehension) and get their message out (eg, ask questions, reflect, explain)
Ensure participants are able to apply the cognitive and behavioural skills taught in the treatmentThis is not directly assessed within the ASK fidelity monitoring
Build in strategies to improve performance of skillsThe fidelity monitor provides specific, tailored feedback to the therapy provider on how to target behaviour change more explicitly. However, the current protocol does not directly assess participants’ performance of skills
EnactmentMonitors and supports participants to use treatment-related skills and strategies in real-life situations
Acknowledges the difference between what is taught (treatment delivery), what is learnt (treatment receipt) and what is used (enactment)
Assess use and performance of cognitive and behavioural skills in an appropriate setting outside of the treatmentThis is not directly assessed within the ASK fidelity monitoring. However, enactment is supported through goal-setting and ongoing reflect on achievement of goals. Furthermore, an essential criteria for the experimental intervention relates to setting homework tasks after each session and reporting on this in the following session