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Interruptive versus Non-Interruptive Reminders for Statin tHerApy in Primary Care (INIRSHA-PC): protocol and statistical analysis plan for a randomised clinical trial

Por: Wright · A. P. · Choi · L. · Nairon · K. G. · Gatto · C. L. · Dear · M. L. · Van Winkle · G. · Lagalante · S. · Neal · E. B. · Wright · A. · Rice · T. W. · for the Vanderbilt Center for Learning Healthcare · Bernard · Dittus · Luther · Pulley · Self · Semler · Qian
Introduction

Statins are a cornerstone of cardiovascular disease prevention yet remain underused among eligible patients. Clinical decision support systems embedded in electronic health records (EHRs) are commonly used to encourage guideline-concordant prescribing. Interruptive reminders (eg, pop-ups) may be effective but interfere with clinical workflows and contribute to alert fatigue. Non-interruptive alerts are less intrusive, but their effectiveness remains unclear. The Interruptive versus Non-Interruptive Reminders for Statin tHerApy in Primary Care (INIRSHA-PC) trial is designed to evaluate the comparative effectiveness of interruptive and non-interruptive reminders on statin-prescribing rates.

Methods and analysis

INIRSHA-PC is a single-centre, pragmatic, three-arm, parallel-group randomised controlled trial embedded in the EHR at Vanderbilt University Medical Center. The trial will enrol adults aged 18–74 seen in primary care who are eligible for, but not currently prescribed, statin therapy. The planned sample size is 3000 patients (1000 per arm). Enrolled patients will be randomised 1:1:1 to (1) interruptive reminder, (2) non-interruptive reminder or (3) no reminder (usual care). The primary outcome is statin prescription within 24 hours of enrolment. Secondary outcomes are statin prescribing within 12 months and low-density lipoprotein cholesterol levels measured between 30 days and 12 months after enrolment. Enrolment began on 14 August 2024. The study is expected to be completed on 19 November 2025.

Ethics and dissemination

The trial has been approved by the Vanderbilt University Medical Center Institutional Review Board with waiver of patient informed consent (IRB number: 240419). Results will be disseminated through peer-reviewed publication and presentation at scientific conferences.

Trial registration number

NCT06456658.

Development and validation of clinical vignettes to inform an educational intervention for physiotherapists to detect serious pathologies: a mixed-methods study

Por: Lackenbauer · W. · Gasselich · S. · Lickel · M. E. · Schabel · L. · Beikircher · R. · Keip · C. · Wieser · M. · Selfe · J. · Mazuquin · B. · Yeowell · G. · Janssen · J.
Objectives

To develop and validate educational clinical vignettes (CVs) based on real-life patients with serious pathology from the disciplines of oncology, internal medicine and orthopaedics that are relevant for physiotherapists (PTs) working in a non-direct access system.

Design

A mixed-methods study using an iterative design was employed to develop and validate CVs that focused on serious pathology.

Setting

Academic and clinical settings within health faculties at three universities in Austria and the UK.

Participants

Medical doctors (MD) (n=3) and PTs (n=4) developed CVs in the disciplines of internal medicine, oncology and orthopaedics. Validation of the CVs was undertaken in three stages: internal validation by the research team (n=7), external validation by MDs (n=3) and external validation by PTs (n=18).

Results

25 CVs focusing on internal medicine (9), oncology (8) and orthopaedics (8) were developed. Results of the consensus method of Haute Autorité de Santé ranged between 7 and 9 in the internal validation stage. In the external validation stage with MDs, one orthopaedic CV was excluded, resulting in a final total of 24 validated CVs.

Conclusions

This is the first time educational CVs have been developed and validated across such a broad range of pathologies for countries without direct access to physiotherapy, for use in the education of PTs. Furthermore, the approach described in the Methods section of this paper may serve as a template in similar future projects.

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