Elizabeth M Schoenfeld1, Kye E Poronsky2, Lauren M Westafer2, Brianna M DiFronzo2, Paul Visintainer3, Charles D Scales4, Erik P Hess5, Peter K Lindenauer6,7,8. 1. Department of Emergency Medicine and Institute for Healthcare Delivery and Population Science, University of Massachusetts Medical School - Baystate, Springfield, MA, USA. ElizSchoen@gmail.com. 2. Department of Emergency Medicine and Institute for Healthcare Delivery and Population Science, University of Massachusetts Medical School - Baystate, Springfield, MA, USA. 3. Department of Medicine, and Institute for Healthcare Delivery and Population Science Epidemiology and Biostatistics Research Core, University of Massachusetts Medical School - Baystate, Springfield, MA, USA. 4. Duke Clinical Research Institute and Division of Urologic Surgery, Duke University School of Medicine, Durham, NC, USA. 5. Department of Emergency Medicine, Vanderbilt University Medical Center, TN, Memphis, USA. 6. Institute for Healthcare Delivery and Population Science, University of Massachusetts Medical School - Baystate, Springfield, MA, USA. 7. Department of Medicine, University of Massachusetts Medical School - Baystate, Springfield, MA, USA. 8. Department of Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, USA.
Abstract
BACKGROUND:Approximately 2 million patients present to emergency departments in the USA annually with signs and symptoms of ureterolithiasis (or renal colic, the pain from an obstructing kidney stone). Both ultrasound and CT scan can be used for diagnosis, but the vast majority of patients receive a CT scan. Diagnostic pathways utilizing ultrasound have been shown to decrease radiation exposure to patients but are potentially less accurate. Because of these and other trade-offs, this decision has been proposed as appropriate for Shared Decision-Making (SDM), where clinicians and patients discuss clinical options and their consequences and arrive at a decision together. We developed a decision aid to facilitate SDM in this scenario. The objective of this study is to determine the effects of this decision aid, as compared to usual care, on patient knowledge, radiation exposure, engagement, safety, and healthcare utilization. METHODS: This is the protocol for an adaptive randomized controlled trial to determine the effects of the intervention-a decision aid ("Kidney Stone Choice")-on patient-centered outcomes, compared with usual care. Patients age 18-55 presenting to the emergency department with signs and symptoms consistent with acute uncomplicated ureterolithiasis will be consecutively enrolled and randomized. Participants will be blinded to group allocation. We will collect outcomes related to patient knowledge, radiation exposure, trust in physician, safety, and downstream healthcare utilization. DISCUSSION: We hypothesize that this study will demonstrate that "Kidney Stone Choice," the decision aid created for this scenario, improves patient knowledge and decreases exposure to ionizing radiation. The adaptive design of this study will allow us to identify issues with fidelity and feasibility and subsequently evaluate the intervention for efficacy. TRIAL REGISTRATION: ClinicalTrials.gov NCT04234035 . Registered on 21 January 2020 - Retrospectively Registered.
RCT Entities:
BACKGROUND: Approximately 2 million patients present to emergency departments in the USA annually with signs and symptoms of ureterolithiasis (or renal colic, the pain from an obstructing kidney stone). Both ultrasound and CT scan can be used for diagnosis, but the vast majority of patients receive a CT scan. Diagnostic pathways utilizing ultrasound have been shown to decrease radiation exposure to patients but are potentially less accurate. Because of these and other trade-offs, this decision has been proposed as appropriate for Shared Decision-Making (SDM), where clinicians and patients discuss clinical options and their consequences and arrive at a decision together. We developed a decision aid to facilitate SDM in this scenario. The objective of this study is to determine the effects of this decision aid, as compared to usual care, on patient knowledge, radiation exposure, engagement, safety, and healthcare utilization. METHODS: This is the protocol for an adaptive randomized controlled trial to determine the effects of the intervention-a decision aid ("Kidney Stone Choice")-on patient-centered outcomes, compared with usual care. Patients age 18-55 presenting to the emergency department with signs and symptoms consistent with acute uncomplicated ureterolithiasis will be consecutively enrolled and randomized. Participants will be blinded to group allocation. We will collect outcomes related to patient knowledge, radiation exposure, trust in physician, safety, and downstream healthcare utilization. DISCUSSION: We hypothesize that this study will demonstrate that "Kidney Stone Choice," the decision aid created for this scenario, improves patient knowledge and decreases exposure to ionizing radiation. The adaptive design of this study will allow us to identify issues with fidelity and feasibility and subsequently evaluate the intervention for efficacy. TRIAL REGISTRATION: ClinicalTrials.gov NCT04234035 . Registered on 21 January 2020 - Retrospectively Registered.
Authors: Michael N Ferrandino; Aditya Bagrodia; Sean A Pierre; Charles D Scales; Edward Rampersaud; Margaret S Pearle; Glenn M Preminger Journal: J Urol Date: 2008-12-18 Impact factor: 7.450
Authors: Erik P Hess; Judd E Hollander; Jason T Schaffer; Jeffrey A Kline; Carlos A Torres; Deborah B Diercks; Russell Jones; Kelly P Owen; Zachary F Meisel; Michel Demers; Annie Leblanc; Nilay D Shah; Jonathan Inselman; Jeph Herrin; Ana Castaneda-Guarderas; Victor M Montori Journal: BMJ Date: 2016-12-05
Authors: Elizabeth M Schoenfeld; Penelope S Pekow; Meng-Shiou Shieh; Charles D Scales; Tara Lagu; Peter K Lindenauer Journal: PLoS One Date: 2017-01-03 Impact factor: 3.240
Authors: Fabienne E Stubenrouch; Arwen H Pieterse; Rijan Falkenberg; T Katrien B Santema; Anne M Stiggelbout; Trudy van der Weijden; J Annemijn W M Aarts; Dirk T Ubbink Journal: Patient Educ Couns Date: 2015-12-30
Authors: Erik P Hess; James L Homme; Anupam B Kharbanda; Leah Tzimenatos; Jeffrey P Louie; Daniel M Cohen; Lise E Nigrovic; Jessica J Westphal; Nilay D Shah; Jonathan Inselman; Michael J Ferrara; Jeph Herrin; Victor M Montori; Nathan Kuppermann Journal: JAMA Netw Open Date: 2018-09-07
Authors: Elizabeth M Schoenfeld; Lauren M Westafer; Samantha A Beck; Benjamin G Potee; Sravanthi Vysetty; Caty Simon; Jillian M Tozloski; Abigail L Girardin; William E Soares Journal: Acad Emerg Med Date: 2022-05-16 Impact factor: 5.221