Reducing Delays in Diagnosing Primary Immunodeficiency Through the Development and Implementation of a Clinical Decision Support Tool: Protocol for a Quality Improvement Project

Background: Primary immunodeficiencies (PIs) 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 PIs are at increased risk for recurrent infections, cancers, and autoimmune diseases. Objective: The aim of this research is to develop and implement a clinical decision support (CDS) tool for the identification of underlying PIs. Methods: We will develop and implement a CDS tool for the identification of underlying PIs among patients who receive primary care through a health care provider at the University of Iowa Hospitals and Clinics. The CDS tool will function through an algorithm that is based on the Immune Deficiency Foundation's 10 Warning Signs for Primary Immunodeficiency. Over the course of a year, we will use Lean Six Sigma principles and the Define, Measure, Analyze, Improve, and Control (DMAIC) framework to guide the project. The primary measure is the number of newly diagnosed PI patients per month. Secondary measures include the following: (1) the number of new patients identified by the CDS as being at high risk for PI, (2) the number of new PI cases in which immunoglobulin replacement or rotating antibiotics are started, (3) the cost of evaluation of each patient identified by the CDS tool as being 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 the Immunology Clinic. Results: This study was determined to not be 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 CDS tool is a promising approach to identifying patients with underlying PI. 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 DMAIC framework, will guide implementation to maximize opportunities for a successful intervention that meets the study's goals and objectives as well as to allow for replication and adaptation of these methods at other sites.