Improving Staff Workflow in Urology Procedure Clinic Using the Model for Improvement.

OBJECTIVE: To maximize procedure volume and minimize workflow inefficiency in our urological procedure clinic, we hypothesized that for staff (nurses/medical assistants) and patient teams, team workflow duration (TWD) (the time required to complete team duties for a single appointment) could be reduced by 50% with a targeted workflow intervention developed using the Model for Improvement and Plan-Do-Study-Act cycles. Workflow inefficiency leads to wasted time and workplace dissatisfaction, resulting in lost revenue due to low procedure volume and high staff turnover. METHODS: A baseline time study was performed to measure TWD for clinical teams, including the front desk, physician, staff, and patient teams. Implementation of previously identified interventions was also recorded. A workflow intervention was developed in which staff duties were split among two roles: staffer and triager. TWD and intervention implementation were remeasured over six Plan-Do-Study-Act cycles. Semistructured interviews were conducted as a balance measure to assess impact on staff workflow and wellness. RESULTS: Our workflow intervention resulted in a 44% and 42% reduction in staff and patient TWD, saving nearly 17 minutes per appointment on average. Thematic analysis revealed that time saved could be best used to protect lunch breaks and allow time to complete nonclinical duties such as patient calls, which had previously been performed after-hours. CONCLUSION: Introduction of staffer and triager roles to staff workflow increased clinic efficiency by reducing workflow and procedure appointment duration. Time saved was used to increase procedure volume while also supporting staff wellness.

Diversity, equity, and inclusion in genitourinary clinical trials leading to FDA novel drug approval: An assessment of the FDA center for drug evaluation and research drug trials snapshot.

To determine the distribution of race and ethnicity among genitourinary oncology trial participants leading to FDA approval of novel molecular entities/biologics. Secondarily, we evaluated whether the proportion of Black participants in clinical trials increased over time. We quired the FDA Center for Drug Evaluation and Research Drug Trials Snapshot (DTS) between 2015 and 2020 for urologic oncology clinical trials leading to FDA approval of novel drugs. Enrollment data was stratified by race and ethnicity. Cochran-Armitage Trend tests were used to examine changes in Black patient participation over years. Nine clinical trials were identified that led to FDA approval of 5 novel molecular entities for prostate and 4 molecular entities for urothelial carcinoma treatment. Trials for prostate cancer included 5202 participants of which 69.8% were White, 4.0% Black, 11.0% Asian, 3.6% Hispanic, <1% American Indian/Alaska Native or Native Hawaiian/Pacific Islander, 3% other. Trials in urothelial carcinoma had 704 participants of which 75.1% were male, 80.8% White, 2.3% Black, 2.4% Hispanic, <1% American Indian/Alaska Native or Native Hawaiian/Pacific Islander, 5% other. Black participation rates over time did not change for urothelial (P = 0.59) or the combined cancer cohort (P = 0.29). Prostate cancer enrollment trends among Black participant declined over time (P = 0.03). Participants in genitourinary clinical trials leading to FDA approval of novel drugs are overwhelmingly white. Involving stakeholders who represent the needs and interests of underrepresented populations in the design and implementation of clinical trials of novel agents may be a strategy to increase diversity, equity, and inclusion among genitourinary clinical trials.

A multi-site pilot study of a parent-centered tool to promote shared decision-making in hypospadias care.

BACKGROUND: Using a user-centered design approach, we conducted a two-site pilot study to evaluate a decision aid (DA) website, the Hypospadias Hub, for parents of hypospadias patients. OBJECTIVES: The objectives were to assess the Hub's acceptability, remote usability, and feasibility of study procedures, and to evaluate its preliminary efficacy. METHODS: From June 2021-February 2022, we recruited English-speaking parents (≥18 years old) of hypospadias patients (≤5 years) and delivered the Hub electronically ≤2 months before their hypospadias consultation. We collected website analytic data using an ad tracker plug-in. We inquired about treatment preference, hypospadias knowledge, and decisional conflict (Decisional Conflict Scale) at baseline, after viewing the Hub (pre-consultation), and post-consultation. We administered the Decision Aid Acceptability Questionnaire (DAAQ) and the Preparation for Decision-Making Scale (PrepDM) which assessed how well the Hub prepared parents for decision-making with the urologist. Post-consultation, we assessed participants' perception of involvement in decision-making with the Shared Decision-making Questionnaire (SDM-Q-9) and the Decision Regret Scale (DRS). A bivariate analysis compared participants' baseline and pre/post-consultation hypospadias knowledge, decisional conflict, and treatment preference. Using a thematic analysis, we analyzed our semi-structured interviews to uncover how the Hub impacted the consultation and what influenced participants' decisions. RESULTS: Of 148 parents contacted, 134 were eligible and 65/134 (48.5%) enrolled: mean age 29.2, 96.9% female, 76.6% White (Extended Summary Figure). Pre/post-viewing the Hub, there was a statistically significant increase in hypospadias knowledge (54.3 vs. 75.6, p < 0.001) and decrease in decisional conflict (36.0 vs. 21.9, p < 0.001). Most participants (83.3%) thought Hub's length and amount of information (70.4%) was "about right", and 93.0% found most or everything was clear. Pre/post-consultation, there was a statistically significant decrease in decisional conflict (21.9 vs. 8.8, p < 0.001). PrepDM's mean score was 82.6/100 (SD = 14.1); SDM-Q-9's mean score was 82.5/100 (SD = 16.7). DCS's mean score was 25.0/100 (SD = 47.03). Each participant spent an average of 25.75 min reviewing the Hub. Based on thematic analysis, the Hub helped participants feel prepared for the consultation. DISCUSSION: Participants engaged extensively with the Hub and demonstrated improved hypospadias knowledge and decision quality. They felt prepared for the consultation and perceived a high degree of involvement in decision-making. CONCLUSION: As the first pilot test of a pediatric urology DA, the Hub was acceptable and study procedures were feasible. We plan to conduct a randomized controlled trial of the Hub versus usual care to test its efficacy to improve the quality of shared decision-making and reduce long-term decisional regret.