Quality improvement initiative for improved patient communication in an ED rapid assessment zone.

INTRODUCTION: Patient-clinician communication in the Emergency Department (ED) faces challenges of time and interruptions, resulting in negative effects on patient satisfaction with communication and failure to relieve anxiety. Our aim was to improve patient satisfaction with communication and to decrease related patient anxiety. METHODS: A multistage quality improvement (QI) initiative was conducted in the ED of Toronto General Hospital, a quaternary care centre in Ontario, Canada, from January to May 2018. We engaged stakeholders widely including clinicians, allied health and patients. We developed a 5-point Likert scale survey to measure patient and clinician rating of their communication experience, along with open-ended questions, and a patient focus group. Inductive analyses yielded interventions that were introduced through three Plan-Do-Study-Act (PDSA) cycles: (1) a clinician communication tool called Acknowledge-Empathize-Inform; (2) patient information pamphlets; and (3) a multimedia solution displaying patient-directed material. Our primary outcome was to improve patient satisfaction with communication and decrease anxiety by at least one Likert scale point over 6 months. Our secondary outcome was clinician-perceived interruptions by patients. We used statistical process control (SPC) charts to identify special cause variation and two-tailed Mann-Whitney U tests to compare means (statistical significance p<0.05). RESULTS: A total of 232 patients and 104 clinicians were surveyed over baseline and three PDSA cycles. Communication about wait times, ED process, timing of next steps and directions to patient areas were the most frequently identified gaps, which informed our interventions. Measurements at baseline and during PDSA 3 showed: patient satisfaction increased from 3.28 (5 being best; n=65) to 4.15 (n=59, p<0.0001). Patient anxiety decreased from 2.96 (1 being best; n=65) to 2.31 (n=59, p<0.001). Clinician-perceived interruptions by patients changed from 4.33 (5 being highest; n=30) to 4.18 (n=11, p=0.98) and did not meet significance. SPC charts showed special cause variation temporally associated with our interventions. CONCLUSIONS: Our pragmatic low-cost QI initiative led to statistically significant improvement in patient satisfaction with communication and decreased patient anxiety while narrowly missing our a priori improvement aim of one full Likert scale point.

Tuberculosis vaccine candidate: Characterization of H4-IC31 formulation and H4 antigen conformation.

Tuberculosis (TB) is one of the leading causes of death worldwide, making the development of effective TB vaccines a global priority. A TB vaccine consisting of a recombinant fusion protein, H4, combined with a novel synthetic cationic adjuvant, IC31®, is currently being developed. The H4 fusion protein consists of two immunogenic mycobacterial antigens, Ag85 B and TB10.4, and the IC31® adjuvant is a mixture of KLK, a leucine-rich peptide (KLKL5KLK), and the oligodeoxynucleotide ODN1a, a TLR9 ligand. However, efficient and robust methods for assessing these formulated components are lacking. Here, we developed and optimized phase analysis light scattering (PALS), electrical sensing zone (ESZ), and Raman, FTIR, and CD spectroscopy methods to characterize the H4-IC31 vaccine formulation. PALS-measured conductivity and zeta potential values could differentiate between the similarly sized particles of IC31® adjuvant and the H4-IC31 vaccine candidate and could thereby serve as a control during vaccine formulation. In addition, zeta potential is indicative of the adjuvant to antigen ratio which is the key in the immunomodulatory response of the vaccine. ESZ was used as an orthogonal method to measure IC31® and H4-IC31 particle sizes. Raman, FTIR, and CD spectroscopy revealed structural changes in H4 protein and IC31® adjuvant, inducing an increase in both the ß-sheet and random coil content as a result of adsorption. Furthermore, nanoDSF showed changes in the tertiary structure of H4 protein as a result of adjuvantation to IC31®. Our findings demonstrate the applicability of biophysical methods to characterize vaccine components in the final H4-IC31 drug product without the requirement for desorption.