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JOURNAL BRIEFS: Urology Practice®: How to Practice What You Preach: An Implementation Science Approach to Increasing Usage of Intravesical Gemcitabine
By: Alexis R. Steinmetz, MD; Jacob Gantz, MD; Kevin Fiscella, MD, MPH; Edward M. Messing, MD | Posted on: 01 Jan 2022
Steinmetz A, Gantz J, Fiscella K et al: Improving rates of immediate postoperative in travesical chemotherapy with gemcitabine for low-grade bladder cancer: an implementation analysis. Urol Pract 2021; 9: 47.
The randomized clinical trial SWOG S0337 provided level 1 evidence that immediate postoperative intravesical gemcitabine (Gem) resulted in an absolute reduction of recurrence of 20% for patients with low grade, nonmuscle invasive bladder cancer.1 Although the University of Rochester Medical Center (URMC) was one of the leading accrual sites for the study, an audit performed at 2 URMC sites 4 months after study accrual closed revealed unexpected findings: only 21% of eligible patients were receiving this therapy.2
But why? Discrepancies such as these between evidence-based practices (EBPs) and clinical care are common in medicine and certainly the field of urology is no exception.3 Despite published data supporting its efficacy, numerous studies have reported low adherence to intravesical chemotherapy (IVC) recommendations with significant practice variation among urologists.4 Barriers to successful implementation of EBPs are usually multilayered and involve patient, provider team and institutional factors.5 Implementation science–the scientific study of methods to promote the uptake of EBPs–seeks to bridge these gaps between research and clinical practice.6 We used an implementation science framework–specifically, the Consolidated Framework for Implementation Research (CFIR)–to guide both an evaluation of barriers to Gem use at our institution and the development of subsequent intervention strategies to overcome them.2,7 The CFIR can be adapted across disciplines and study contexts; relevant constructs are used to guide an evaluation of the implementation setting, appraise implementation progress and organize research findings.7
We performed a retrospective chart review audit to determine usage rates of Gem after transurethral resection of bladder tumors (TURBTs) at 2 URMC hospitals, Strong Memorial Hospital (SMH) and Highland Hospital (HH). Pre-intervention rates of appropriate use of Gem were 11% at SMH and 37% at HH (see figure). Using CFIR as a guide, we identified stakeholders (those invested in or affected by the implementation) and so-called champions (those who support the implementation and help overcome resistance within an organization).7 We also clarified the organizational context and baseline operational characteristics that influenced whether Gem was given to an eligible patient.2
The CFIR provides guidance on how to systematically collect data on relevant barriers to an implementation. We conducted semi-structured interviews with individuals at various levels of the Gem supply chain and sent an online survey to URMC urologists. The CFIR was used to organize themes from our data into domains defined by the framework that have been shown to impact implementation. Since there is no validated tool for selecting strategies to address CFIR domains and barriers, we adapted our interventions from the evidence-based methods listed in the Expert Recommendations for Implementing Change. The Expert Recommendations for Implementing Change provide standardized implementation terminology and suggestions for evidence-driven implementation strategies.2,8
We found that the major impediments to Gem use at our institution were logistical workflow issues, which are referred to as friction in behavioral economics. These arose at almost every level of care delivery, beginning in the outpatient clinic when TURBT cases were first booked to the post-anesthesia care unit where Gem needed to be properly handled and disposed of. During S0337, the details of the Gem workflow were the responsibility of a study coordinator, not the URMC providers and nursing staff. The processes surrounding identifying patients likely to benefit from the therapy, ensuring timely drug delivery and proper instillation, and managing post-instillation issues were cumbersome and simply not feasible without the support of the study.2
Our intervention strategies were devised through collaborative efforts of the research team and key stakeholders from each involved department. We created educational materials and conducted training sessions to ensure that ordering, dispensing and handling Gem were streamlined. Designated individuals from leadership in each department were asked to provide feedback and input at regular intervals. The results were impressive; repeat usage audits measured practice change at 1 year, and rates of appropriate use of Gem had increased to 88% at SMH and 94% at HH (see figure). This overall increase from 21% to 91% meant that more patients had access to an evidence-based therapy aimed at reducing their chances of cancer recurrence–effectively bridging the gap in research and practice at our institution.2
The underutilization of immediate postoperative IVC agents for patients with nonmuscle invasive bladder cancer may lead to avoidable morbidity and additional treatment costs. Our findings are consistent with other studies demonstrating that only 11%–28% of eligible patients receive post-TURBT IVC appropriately.4,9 Data suggest that physician factors (awareness and bias, fellowship, practice location and volume), patient factors (recurrence and progression risk), and local pharmacy and hospital circumstances influence IVC usage rates.4,10
Our study results support the argument that systematic, evidence-based methods should be used to improve utilization of EBPs in urology. Using an implementation science approach, we increased our rates of postoperative IVC with Gem by over 300% within 1 year.2 The CFIR framework can be adapted by institutions interested in improving post-TURBT Gem usage or the adoption of other urological EBPs.
- Messing EM, Tangen CM, Lerner SP et al: Effect of intravesical instillation of gemcitabine vs saline immediately following resection of suspected low-grade non–muscle-invasive bladder cancer on tumor recurrence: SWOG S0337 randomized clinical trial. JAMA 2018; 319: 1880.
- Steinmetz A, Gantz J, Fiscella K et al: Improving rates of immediate postoperative intravesical chemotherapy with gemcitabine for low-grade bladder cancer: an implementation analysis. Urol Pract 2021; 9: 47.
- Balas EA and Boren SA: Managing clinical knowledge for health care improvement. Yearb Med Inform 2000; 1: 65.
- Cookson MS, Chang SS, Oefelein MG et al: National practice patterns for immediate postoperative instillation of chemotherapy in nonmuscle invasive bladder cancer. J Urol 2012; 187: 1571.
- Ferlie EB and Shortell SM: Improving the quality of health care in the United Kingdom and the United States: a framework for change. Milbank Q 2001; 79: 281.
- Eccles MP and Mittman BS: Welcome to implementation science. Implement Sci 2006; 1: 1.
- Damschroder LJ, Aron DC, Keith RE et al: Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci 2009; 4: 50.
- Waltz TJ, Powell BJ, Chinman MJ et al: Expert Recommendations for Implementing Change (ERIC): protocol for a mixed methods study. Implement Sci 2014; 9: 39.
- Seo GH, Kim JH and Ku JH: Clinical practice pattern of immediate intravesical chemotherapy following transurethral resection of a bladder tumor in Korea: national health insurance database study. Sci Rep 2016; 6: 22716.
- Palou-Redorta J, Rouprêt M, Gallagher JR et al: The use of immediate postoperative instillations of intravesical chemotherapy after TURBT of NMIBC among European countries. World J Urol 2014; 32: 525.