Inventi Impact: Emergency Medicine

Inventi:hem/29137/19

Assessing Treatment Fidelity Within an Epilepsy Randomized Controlled Trial: Seizure First Aid Training for People with Epilepsy Who Visit Emergency Departments

Purpose. To measure fidelity with which a group seizure first aid training intervention was delivered within a pilot randomized\ncontrolled trial underway in the UK for adults with epilepsy who visit emergency departments (ED) and informal carers.\nEstimates of its effects, including on ED use, will be produced by the trial. Whilst hardly ever reported for trials of epilepsy\nInterventions- only one publication on this topic exists-this study provides the information on treatment fidelity necessary to\nallow the trialâ??s estimates to be accurately interpreted. This rare worked example of how fidelity can be assessed could also\nprovide guidance sought by neurology trialists on how to assess fidelity. Methods. 53 patients who had visited ED on less than equal to 2\noccasions in prior year were recruited for the trial; 26 were randomized to the intervention. 7 intervention courses were\ndelivered for them by one facilitator. Using audio recordings, treatment â??adherenceâ? and â??competenceâ? were assessed.\nAdherence was assessed by a checklist of the items comprising the intervention. Using computer software, competence was\nmeasured by calculating facilitator speech during the intervention (didacticism). Interrater reliability was evaluated by two\nindependent raters assessing each course using the measures and their ratings being compared. Results. The fidelity measures\nwere found to be reliable. For the adherence instrument, raters agreed 96% of the time, PABAK-OS kappa 0.91. For didacticism,\nratersâ?? scores had an intraclass coefficient of 0.96. In terms of treatment fidelity, not only were courses found to have been\ndelivered with excellent adherence (88% of its items were fully delivered) but also as intended they were highly interactive, with\nthe facilitator speaking for, on average, 55% of course time. Conclusions. The fidelity measures used were reliable and showed\nthat the intervention was delivered as attended. Therefore, any estimates of intervention effect will not be influenced by poor\nimplementation fidelity.