JMIR Publications

ABSTRACT

Background:

Making informed decisions about clinical trial participation can be overwhelming for patients due to the complexity of trial information, potential risks and benefits, and the emotional burden of a recent diagnosis. Patient decision aids (PDAs) simplify this process by providing clear information on treatment options, empowering patients to actively participate in shared decision-making (SDM) with their doctors. While PDAs have shown promise in various healthcare contexts, their use in clinical trials, particularly in the form of trial-specific PDAs (tPDAs), remains underutilized.

Objective:

To address the challenge of patient comprehension of traditional clinical trial materials, we developed a freely accessible, user-friendly tPDA within the context of the ImmunoSABR phase 2 trial. The tPDA aimed to enhance informed decision-making regarding trial participation. The primary endpoint was usability, quantitatively measured by the System Usability Scale (SUS). Secondary endpoints included time spent on the tPDA, patient satisfaction ratings, and participants’ self-reported level of understanding of the trial.

Methods:

We developed the tPDA following the International Patient Decision Aid Standards (IPDAS) and validated through a structured, three-phase iterative evaluation process. Initial evaluation was performed with 17 computer scientists who had expertise in biomedical applications, ensuring technical robustness. The content and usability were further refined through evaluations involving 10 clinicians and 8 medical students, focusing on clinical accuracy and user-friendliness. Lastly, the tool was tested by six patients eligible for the ImmunoSABR trial, to assess real-world applicability and patient-centered design.

Results:

Evaluations demonstrated the tPDA's (my-tpda.web.app) effectiveness in enhancing informed decision-making, directly addressing our primary endpoint of usability with an overall mean SUS score of 79.4, indicative of good usability. Addressing our secondary endpoints, patients completed the tPDA efficiently, with the majority (four out of six) finishing in under 30 minutes, and all but one within 60 minutes. The mean satisfaction rating was 9.5 out of 10. Qualitative feedback highlighted significant improvements in patients' understanding of the trial details, reinforcing the tPDA's role in facilitating better patient engagement and comprehension.

Conclusions:

Our study demonstrates the feasibility and potential of tPDAs to enhance patient comprehension and engagement in clinical trials. Integrating tPDAs offers a valuable addition to traditional paper-based and verbal communication methods, promoting informed decision-making and patient-centered care. Clinical Trial: ImmunoSABR Protocol Code: NL67629.068.18; EudraCT: 2018–002583-11; Clinicaltrials.gov: NCT03705403 and NCT04604470; ISRCTN ID: ISRCTN49817477; Date of registration: 03-April-2019.