Study protocol for a prospective, cluster randomised control, hybrid type 1 effectiveness-implementation trial to evaluate the R eduction O f
Hamada H Altalib, Poojith Nuthalapati, Sana F Ali, Margaret Gopaul, Chinenye M Okafor, Bridget Gaglio, Abigail Herbst, Sohail Dewain, Saifeldin Hossameldin, Fabio Speranza, Priyanka Deep, Kelly Fischbein, Lawrence J Hirsch, Mary Jo Pugh, Heidi Munger ClaryIntroduction
Epilepsy affects 1% of the US population, imposing a significant burden through seizures, distress and medication side effects. Many adverse outcomes can be reduced with patient education and an acute seizure action plan. Electronic health record clinical templates can support this care but are often seen as burdensome. This study will develop a clinical template embedding an acute seizure action plan into routine neurology visits and examine its effect on care quality and healthcare use, as well as barriers and facilitators to adoption.
Methods and analysis
This study is a single-site, prospective, quality improvement, hybrid type 1 effectiveness-implementation study, sequential mixed-method design. Providers are randomised to either the acute seizure action plan plus general health education, or general health education alone control group, with 10 patients per provider enrolled over 12–15 months and followed for 1 year. Phase 1 will collect baseline interviews and pre-enrolment seizure outcomes. Phase 2 will implement the intervention with quantitative data along with provider interviews at 6 months. Phase 3 will include 12-month interviews to assess real-world use of the acute seizure action plan. The primary outcome is change in epilepsy quality measure scores before and after implementation between groups. Secondary outcomes include changes in individual quality measures, seizure metrics and healthcare utilisation. Implementation processes will be assessed by the Unified Theory of Acceptance and Use of Technology and Theoretical Domains Framework.
Ethics and dissemination
The study was approved by the Yale Institutional Review Board (Protocol ID: 2000032913). Findings will be disseminated through peer-reviewed publications and conference presentations.