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An Evaluation of a Web-Based Decision Aid for Treatment Planning of Small Kidney Tumors: Pilot Randomized Controlled
Justin Fogarty1, Mutita Siriruchatanon1, Danil Makarov2,3
1Department of Radiology, New York University Grossman School of Medicine, New York, NY, United States.
Background:
Surgery is the most common treatment for localized small kidney masses (SKMs) up to 4 cm, despite a lack of evidence for improved overall survival. Nonsurgical management options are gaining recognition, as evidence supports the indolence of most SKMs. Decision aids (DAs) have been shown to improve patient comprehension of the trade-offs of treatment options and overall decision quality, and may improve consideration of all major options according to individual health priorities and preferences.
Objective:
This pilot randomized controlled trial (RCT) primarily aims to evaluate the impact of a new web-based DA on treatment decisions for patients with SKM; that is, selection of surgical versus nonsurgical treatment options. Secondary objectives include an assessment of decision-making outcomes: decisional conflict, decision satisfaction, and an understanding of individual preferences for treatment that incorporate the trade-offs associated with surgical versus nonsurgical interventions.
Methods:
Three phases comprise the construction and evaluation of a new web-based DA on SKM treatment. In phase 1, this DA was developed in print format through a multidisciplinary design committee incorporating patient focus groups. Phase 2 was an observational study on patient knowledge and decision-making measures after randomization to receive the printed DA or institutional educational materials, which identified further educational needs applied to a web-based DA. Phase 3 will preliminarily evaluate the web-based DA: in a pilot RCT, 50 adults diagnosed with SKMs will receive the web-based DA or an existing web-based institutional website at urology clinics at a large academic medical center. The web-based DA applies risk communication and information about diagnosis and treatment options, elicits preferences regarding treatment options, and provides a set of options to consider with their doctor based on a decision-analytic model of benefits/harm analysis that accounts for comorbidity, age group, and tumor features. Questionnaires and treatment decision data will be gathered before and after viewing the educational material.
Results:
This phase will consist of a pilot RCT from August 2022 to January 2023 to establish feasibility and preliminarily evaluate decision outcomes. Previous study phases from 2018 to 2020 supported the feasibility of providing the printed DA in urology clinics before clinical consultation and demonstrated increased patient knowledge about the diagnosis and treatment options and greater likelihood of favoring nonsurgical treatment just before consultation. This study was funded by the National Cancer Institute. Recruitment will begin in August 2022.
Conclusions:
A web-based DA has been designed to address educational needs for patients making treatment decisions for SKM, accounting for comorbidities and treatment-related benefits and risks. Outcomes from the pilot trial will evaluate the potential of a web-based DA in personalizing treatment decisions and in helping patients weigh attributes of surgical versus nonsurgical treatment options for their SKMs.
Trial Registration:
ClinicalTrials.gov NCT05387863; https://clinicaltrials.gov/ct2/show/NCT05387863.
International Registered Report Identifier (Irrid):
PRR1-10.2196/41451.
Insights
A new web-based decision aid (DA) helps patients with small kidney masses (SKMs) understand treatment options, potentially improving decision quality and favoring less invasive choices. This pilot study evaluates its impact on treatment selection.
Area of Science:
- Urology
- Decision Science
- Health Informatics
Background:
- Localized small kidney masses (SKMs) are often treated with surgery, despite limited survival benefit evidence.
- Nonsurgical management is increasingly recognized for indolent SKMs.
- Decision aids (DAs) enhance patient comprehension of treatment trade-offs and decision quality.
Purpose of the Study:
- To evaluate a new web-based decision aid's impact on treatment selection (surgical vs. nonsurgical) for SKM patients.
- To assess secondary outcomes including decisional conflict, satisfaction, and preference understanding.
Main Methods:
- A three-phase approach involved developing a print DA, followed by an observational study, culminating in a pilot randomized controlled trial (RCT).
- The pilot RCT (Phase 3) involved 50 adults with SKMs, comparing a web-based DA to an existing institutional website.
- The web-based DA incorporates risk communication, preference elicitation, and a decision-analytic model considering patient factors.
Main Results:
- Previous phases demonstrated the feasibility of print DA delivery and increased patient knowledge favoring nonsurgical options.
- The pilot RCT (August 2022-January 2023) aims to establish feasibility and preliminarily evaluate decision outcomes.
- Funding provided by the National Cancer Institute; recruitment began August 2022.
Conclusions:
- A web-based DA has been developed to address educational needs for SKM treatment decisions, considering comorbidities and risks.
- The pilot trial will assess the DA's potential for personalizing treatment choices and aiding patients in weighing surgical versus nonsurgical options.
