Reducing Delays in Diagnosing Primary Immunodeficiency Through the Development and Implementation of a Clinical Decision Support Tool: A Study Protocol (Preprint)

BACKGROUND Primary immunodeficiencies are a set of heterogeneous chronic disorders characterized by immune dysfunction. They are diagnostically challenging because of their clinical heterogeneity, knowledge gaps among primary care physicians, and continuing shortages of clinically trained immunologists. As a result, patients with undiagnosed primary immunodeficiencies are at increased risk for recurrent infections, cancers, and autoimmune diseases. OBJECTIVE This article outlines a quality improvement protocol to develop and implement a clinical decision support tool that helps reduce delays in diagnosing primary immunodeficiencies. METHODS We will develop and implement a clinical decision support tool for the identification of underlying primary immunodeficiencies among patients who receive primary care through a health care provider at the University of Iowa Hospitals and Clinics. The clinical decision support tool will function through an algorithm that is based on the Immune Deficiency Foundation’s 10 Warning Signs for Primary Immunodeficiency. Through the course of a year, we will use Lean Six Sigma principles and the DMAIC (Define-Measure-Analyze-Improve-Control) Framework to guide the project. The primary measure is the number of newly diagnosed primary immunodeficiency patients per month. Secondary measures include: (1) the number of new patients identified by the CDS at high risk for PI, (2) the number of new PI cases in which IVIG or rotating antibiotics are started, (3) the cost of evaluation of each patient identified by CDS tool at high risk for PIs, (4) the number of new consults not diagnosed with a PI, and (5) patient satisfaction with the process of referral to Immunology Clinic. RESULTS This study was determined to be non-human subjects research by the Institutional Review Board at the University of Iowa. Data collection will begin in August 2021. CONCLUSIONS The development and implementation of a clinical decision support tool is a promising approach to identifying patients with underlying primary immunodeficiency. This protocol assesses whether such an approach will be able to achieve its objective of reducing diagnostic delays. The disciplined approach, using Lean Six Sigma and the Define-Measure-Analyze-Improve-Control framework, will guide the implementation to maximize opportunities for success.