Comprehensive fidelity framework developed by the NIH BCC (synthesised from 1, 2, 3), with the ASK fidelity protocol mapped alongside these recommendations
| Domain | Rationale | NIH BCC recommendations | Fidelity protocol within the ASK trial |
| Study design | Ensures the study adequately tests its hypotheses | Specify the theoretical model underlying the treatments and define the ‘active ingredients’ of the treatment | Theoretical underpinnings identified and ‘active ingredients’ proposed |
| Conduct a pilot study to improve the treatment’s acceptability, feasibility and effectiveness | Pilot study conducted37 | ||
| Specify the treatment dose within and across conditions and ensure this is delivered | Treatment dose set a priori and non-adherence is recorded as a protocol deviation | ||
| Plan how to monitor adherence to the protocol for therapy providers | Fidelity plan developed, as reported in the current study | ||
| Plan how to record protocol deviations | Training provided to trial staff to identify protocol deviations, which are reported and recorded in REDCap | ||
| Describe the treatment(s) in a standardised manual | Each treatment described in a standardised manual | ||
| Plan how to manage setbacks, eg, attrition of providers | All sites/clusters receive initial face-to-face training. Subsequent training (eg, for new staff or booster training) is delivered via video conference | ||
| Training | Well-trained providers are more likely to follow the protocol and show increased competency | Therapy 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 styles | Training 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 training | Not assessed in the current protocol | ||
| Develop a training plan to ensure providers maintain skills, eg, ongoing coaching and feedback, booster training sessions | Booster 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 arms | Training 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 delivery | Ensures 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 deviations | This is not directly assessed within the ASK fidelity monitoring |
| Monitor non-specific treatment effects, eg, perceived differences in providers’ warmth and credibility, participant expectations | Fidelity 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 treatments | Audio-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 dose | Therapy providers receive the fidelity criteria prior to administering their first session Booster training offered | ||
| Reduce the risk of contamination between treatments | Therapy 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 sessions | All treatment sessions are video recorded and a selection are reviewed by the fidelity monitor | ||
| Treatment receipt | Investigates whether the participant understood the treatment and can demonstrate knowledge of or application of the skills taught in the treatment | Ensure participants understand the information provided in the treatment | This 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 treatment | This is not directly assessed within the ASK fidelity monitoring | ||
| Build in strategies to improve performance of skills | The 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 | ||
| Enactment | Monitors 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 treatment | This 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 |