{
  "abstract": "Introduction 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.",
  "authors": [
    {
      "affiliations": [
        "Department of Neurology, Yale Comprehensive Epilepsy Center, Yale University School of Medicine, New Haven, Connecticut, USA",
        "Veteran Administration (VA) Epilepsy Center of Excellence, West Haven, Connecticut, USA"
      ],
      "name": "Hamada H Altalib"
    },
    {
      "affiliations": [
        "Department of Neurology, Yale Comprehensive Epilepsy Center, Yale University School of Medicine, New Haven, Connecticut, USA",
        "Veteran Administration (VA) Epilepsy Center of Excellence, West Haven, Connecticut, USA"
      ],
      "name": "Poojith Nuthalapati"
    },
    {
      "affiliations": [
        "HOBSCOTCH Institute for Cognitive Health and Well-Being, Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, USA",
        "Department of Psychiatry, Michigan State University, Lansing, Michigan, USA"
      ],
      "name": "Sana F Ali"
    },
    {
      "affiliations": [
        "Department of Neurology, Yale Comprehensive Epilepsy Center, Yale University School of Medicine, New Haven, Connecticut, USA",
        "Veteran Administration (VA) Epilepsy Center of Excellence, West Haven, Connecticut, USA"
      ],
      "name": "Margaret Gopaul"
    },
    {
      "affiliations": [
        "Department of Internal Medicine, Medical University of South Carolina Health, Florence, South Carolina, USA"
      ],
      "name": "Chinenye M Okafor"
    },
    {
      "affiliations": [
        "PPD Evidera Patient-Centered Research, Thermo Fisher Scientific, Waltham, Massachusetts, USA"
      ],
      "name": "Bridget Gaglio"
    },
    {
      "affiliations": [
        "PPD Evidera Patient-Centered Research, Thermo Fisher Scientific, Waltham, Massachusetts, USA"
      ],
      "name": "Abigail Herbst"
    },
    {
      "affiliations": [
        "Department of Neurology, Yale Comprehensive Epilepsy Center, Yale University School of Medicine, New Haven, Connecticut, USA"
      ],
      "name": "Sohail Dewain"
    },
    {
      "affiliations": [
        "Department of Neurology, Yale Comprehensive Epilepsy Center, Yale University School of Medicine, New Haven, Connecticut, USA"
      ],
      "name": "Saifeldin Hossameldin"
    },
    {
      "affiliations": [
        "PPD Evidera Patient-Centered Research, Thermo Fisher Scientific, London, UK"
      ],
      "name": "Fabio Speranza"
    },
    {
      "affiliations": [
        "UCB, Smyrna, Georgia, USA"
      ],
      "name": "Priyanka Deep"
    },
    {
      "affiliations": [
        "UCB, Smyrna, Georgia, USA"
      ],
      "name": "Kelly Fischbein"
    },
    {
      "affiliations": [
        "Department of Neurology, Yale Comprehensive Epilepsy Center, Yale University School of Medicine, New Haven, Connecticut, USA"
      ],
      "name": "Lawrence J Hirsch"
    },
    {
      "affiliations": [
        "Informatics, Decision-Enhancement and Analytic Sciences Center, VA Salt Lake City Health Care System, Salt Lake City, Utah, USA",
        "Division of Epidemiology, University of Utah, Salt Lake City, Utah, USA"
      ],
      "name": "Mary Jo Pugh"
    },
    {
      "affiliations": [
        "Department of Neurology, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA"
      ],
      "name": "Heidi Munger Clary"
    }
  ],
  "title": "Study protocol for a prospective, cluster randomised control, hybrid type 1 effectiveness-implementation trial to evaluate the Reduction Of Seizures through Education and Support: the ROSES study",
  "uid": "b1234e77-87dc-5abe-a48a-c98fb405aacf"
}