Dataset Information

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

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

SUBMITTER: Noble AJ

PROVIDER: S-EPMC6378079 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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

Noble Adam J AJ Snape Darlene D Ridsdale Leone L Morgan Myfanwy M Nevitt Sarah J SJ Goodacre Steve S Marson Anthony A

Behavioural neurology 20190203

<h4>Purpose</h4>To measure fidelity with which a group seizure first aid training intervention was delivered within a pilot randomized controlled trial underway in the UK for adults with epilepsy who visit emergency departments (ED) and informal carers. Estimates of its effects, including on ED use, will be produced by the trial. Whilst hardly ever reported for trials of epilepsy interventions-only one publication on this topic exists-this study provides the information on treatment fidelity nec ...[more]

PMID: 30863463

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Project description:ObjectiveTo determine the feasibility and optimal design of a randomised controlled trial (RCT) of Seizure First Aid Training For Epilepsy (SAFE).DesignPilot RCT with embedded microcosting.SettingThree English hospital emergency departments (EDs).ParticipantsPatients aged ?16 with established epilepsy reporting ?2 ED visits in the prior 12 months and their significant others (SOs).InterventionsPatients (and their SOs) were randomly allocated (1:1) to SAFE plus treatment-as-usual (TAU) or TAU alone. SAFE is a 4-hour group course.Main outcome measuresTwo criteria evaluated a definitive RCT's feasibility: (1) ?20% of eligible patients needed to be consented into the pilot trial; (2) routine data on use of ED over the 12?months postrandomisation needed securing for ?75%. Other measures included eligibility, ease of obtaining routine data, availability of self-report ED data and comparability, SAFE's effect and intervention cost.ResultsOf ED attendees with a suspected seizure, 424 (10.6%) patients were eligible; 53 (12.5%) patients and 38 SOs consented. Fifty-one patients (and 37 SOs) were randomised. Routine data on ED use at 12?months were secured for 94.1% patients. Self-report ED data were available for 66.7% patients. Patients reported more visits compared with routine data. Most (76.9%) patients randomised to SAFE received it and no related serious adverse events occurred. ED use at 12 months was lower in the SAFE+TAU?arm compared with TAU alone, but not significantly (rate ratio=0.62, 95% CI 0.33 to 1.17). A definitive trial would need ~674 patient participants and ~39 recruitment sites. Obtaining routine data was challenging, taking ~8.5 months.ConclusionsIn satisfying only one predetermined 'stop/go' criterion, a definitive RCT is not feasible. The low consent rate in the pilot trial raises concerns about a definitive trial's finding's external validity and means it would be expensive to conduct. Research is required into how to optimise recruitment from the target population.Trial registration numberISRCTN13871327.

Project description:ObjectivesTo establish the appropriateness of a previously developed seizure care pathway by exploring to what extent patients valued the intervention and perceived it as being helpful or not.DesignQualitative descriptive study, using semistructured, in-depth interviews and thematic template analysis, theoretically informed by critical realism.SettingIn North West England, a seizure care pathway has been developed in collaboration with a specialist neurology hospital to support clinical management of seizure patients on initial presentation to the emergency department (ED), as well as access to follow-up services on discharge, with the aim of improving patient experience. Three National Health Service (NHS) EDs and a specialist neurology hospital provided the setting for participant recruitment to this study.Participants181 patients fulfilled the inclusion criterion with 27 participants taking part following their experience of an ED attendance and outpatient follow-up appointment after a seizure.ResultsFive main themes emerged from the data: decision to seek care, responsiveness of services, waiting and efficiency, information and support, and care continuity. Two integrative themes spanned the whole study: lived experience and communication. This paper reports on two of the main themes: care continuity, and waiting and efficiency. The average time between ED presentation and interview completion was 100 days.ConclusionsImplementation of a care pathway is a complex intervention, requiring long-term follow-up to assess its integration into practice and effectiveness in service improvement. The seizure care pathway has the potential to enhance the care of seizure patients in the ED and at follow-up by improving continuity and management of care. The study demonstrates good aspects of the seizure care pathway as observed by patients and also recognises shortcomings within current service provision and questions what the NHS should and should not be delivering. Our study suggests various ways to enhance the pathway at service level to potentially drive improved patient experience.

Dataset Information

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

Publications

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

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