A Randomized Controlled Trial to Compare the Effectiveness of Dissemination Tools to Share Research Results With Patients - SPIN-CLEAR Trial #1

Background: Research ethics guidance mandates that study results be shared with participants, and CIHR's Knowledge Translation Strategy emphasizes dissemination to others with relevant lived experiences. Yet, most researchers do not share results with patients, and do not know which dissemination tools (e.g., lay summaries, infographics, podcasts) or tool features best facilitate effective communication. Only 3 randomized controlled trials (RCTs) have compared tool effectiveness, and none assessed which approaches work best for which patients. Comparative effectiveness trials are needed to build an evidence base to help us understand what tools are most effective for communicating different types of research to different patients. The investigators will use the multinational Scleroderma Patient-centered Intervention Network (SPIN) Cohort to conduct a series of RCTs to compare tools among people with systemic sclerosis, or scleroderma. The first trial in the series will compare a research dissemination tool (infographic) against a plain-language summary comparator.

Objectives: An effective tool must communicate information patients want to know, understandably, in an easy-to-use format. The trial will compare the effectiveness of an infographic and lay summary, overall and for patients with different sociodemographic or educational characteristics.

Primary Objectives: The first trial will compare tools based on (1) information completeness; (2) understandability; and (3) ease of use, as prioritized by our Patient Advisory Team.

Secondary Objectives: The investigators will evaluate comprehension of key aspects of disseminated research; likelihood that participants would enroll in a similar future study; and, for all primary and secondary outcomes, analyze effects by participant characteristics (e.g., age, country, language, education level, eHealth literacy).

Methods: Parallel-group RCT that will compare 2 tools (infographic and plain-language summary comparator. For this trial, SPIN patients and researchers will select systemic sclerosis research to disseminate. Tools will be developed by experienced tool developers, patients, and researchers. SPIN Cohort participants (N = 1,250 and growing) will be invited to enrol, and those enrolled will be randomized to a dissemination tool and complete outcomes. Response options will be 0 to 10 numerical rating scales (0 = strongly disagree, 10 = strongly agree). The primary analysis will be intention-to-treat, using a linear mixed effects model with multiple observations per participant (using the lmer function from the lme4 package in R).