scholarly journals Feasibility and Efficacy of a Decision Aid for Emergency Department Patients with Suspected Ureterolithiasis: Protocol for an Adaptive Randomized Controlled Trial

2021 ◽  
Author(s):  
Elizabeth M Schoenfeld ◽  
Kye E Poronsky ◽  
Lauren M Westafer ◽  
Paul Visintainer ◽  
Brianna M DiFronzo ◽  
...  

Abstract Background: Approximately 2 million patients present to Emergency Departments in the US 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 - NCT04234035https://clinicaltrials.gov/ct2/show/NCT04234035Registered January 21, 2020 – Retrospectively Registered

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Elizabeth M. Schoenfeld ◽  
Kye E. Poronsky ◽  
Lauren M. Westafer ◽  
Brianna M. DiFronzo ◽  
Paul Visintainer ◽  
...  

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


2002 ◽  
Vol 9 (4) ◽  
pp. 253-259 ◽  
Author(s):  
Robert L Cowie ◽  
Margot F Underwood ◽  
Cinde B Little ◽  
Ian Mitchell ◽  
Sheldon Spier ◽  
...  

BACKGROUND: Asthma is common and is often poorly controlled in adolescent subjects.OBJECTIVE: To determine the impact of an age-specific asthma program on asthma control, particularly on exacerbations of asthma requiring emergency department treatment, and on the quality of life of adolescents with asthma.METHODS: The present randomized, controlled trial included patients who were 15 to 20 years of age and had visited emergency departments for management of their asthma. The interventional group attended an age-specific asthma program that included assessment, education and management by a team of asthma educators, respiratory therapists and respiratory physicians. In the control group, spirometry was performed, and the patients continued to receive usual care from their regular physicians. The outcomes were assessed by a questionnaire six months after entry into the study.RESULTS: Ninety-three subjects entered the study and were randomly assigned to the intervention or control group. Of these, only 62 patients were available for review after six months. Subjects in both the control and the intervention groups showed a marked improvement in their level of asthma control, reflected primarily by a 73% reduction in the rate of emergency department attendance for asthma. Other indexes of disease control, including disease-specific quality of life, as assessed by questionnaires, were improved. There was, however, no discernible difference between the subjects in the two groups, with the exception of an improvement in favour of the intervention group in the symptom (actual difference 0.7, P=0.048) and emotional (actual difference 0.8, P=0.028) domains of the asthma quality of life questionnaire. The overall quality of life score favoured the intervention group by a clinically relevant difference of 0.6, but this difference did not reach statistical significance (P=0.06).CONCLUSIONS: Although all subjects demonstrated a significant improvement in asthma control and quality of life, the improvement attributable to this intervention was limited to two domains in disease-specific quality of life.


2007 ◽  
Vol 14 (8) ◽  
pp. 702-708 ◽  
Author(s):  
Brian R. Holroyd ◽  
Michael J. Bullard ◽  
Karen Latoszek ◽  
Debbie Gordon ◽  
Sheri Allen ◽  
...  

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