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Table 1 Quality of intervention delivery

From: Quality of intervention delivery in a cluster randomised controlled trial: a qualitative observational study with lessons for fidelity

Quality of implementation Definition Observations (examples are taken from our observational data)
Enhancement Practitioners build on the intervention (“go the extra mile”) to optimise its effectiveness [Nurse] who is the champion for Soft Words told me that she had changed the poster for the day and that she had gone around the ward showing it to all the nursing staff
Protocol compliant Practitioners implement the intervention as instructed [Nurse] approached me to let me know she did a 1:1 session and her patient was agitated so she had offered him the Calm Down Methods box. She said he chose the herbal tea and penguin to hug overnight
Fidelity-consistent modification Practitioners adapt the intervention to make it work, or work better, in a particular context, whilst retaining the essential elements of the intervention After we had spoken to [ward manager] it was agreed that we would amend some of the language in the [Soft Words] posters so that all staff would be able to understand the message and be involved in the intervention
Business-as-usual Practitioners implement the intervention as instructed but practice is unchanged because they view it as what they were already doing before the trial started [Ward] did prepare for a restraint but staff were able to contain the situation by asking other patients not to interfere and offering to make the situation better for the patient by going to the shops and buying him the items he was requesting. Staff were working within the Talk Down framework as they generally do and this appeared effective. However, I believe that this was more reflective of how [ward] generally runs than of the intervention itself
Dilution Participants do not do all they are supposed to do, such that this will dilute the impact of the intervention Staff came up with a lot of [Mutual Expectations] suggestions however many were not in keeping with the rationale of the intervention – felt like a set of rules for patients other than mutual expectations (e.g. families must call the ward first before visiting, no takeaways after 8 pm etc.) Although almost all staff had been trained in this intervention. I had spoken to the manager about it in detail; I felt that they struggled to understand the values underpinning it
Fidelity-inconsistent modification Practitioners adapt the intervention in a way that is not in keeping with the ‘spirit’ of the intervention, which would probably reduce or nullify its impact He told me how staff had discussed using the [Calm Down Methods] iPod as a reward for good behaviour for the disruptive patient on the ward. They also planned to take it away should he cause disruption
No implementation Practitioners do not implement the intervention Gave him and two other night staff Know Each Other forms. [Healthcare Assistant] vehemently refused to fill it in saying she doesn’t want them to know anything because they [the patients] will make fun of you