Measuring Patient-Reported Acceptability Outcomes via the Program Acceptability Tool for Telehealth.

Introduction: Assessing treatment acceptability is critical to understanding patient experiences in clinical trials, especially in telehealth settings where exposure and engagement experiences are unique. However, the use of patient-reported acceptability outcomes in mental health-focused trials has been mixed, with most published studies relying on objective behavior (e.g., dropout rates) or fit-for-use measures, rather than instruments rooted in a specific theoretical model. This study introduces the Program Acceptability Tool for Telehealth (PATT), a novel, theoretically grounded instrument designed to capture patient-reported acceptability in telehealth-based trials. Methods: Here, we describe the initial development and validation of the PATT, including its performance with 123 caregivers participating in an ongoing clinical trial that includes multiple types of interventions and support programs focused on caregiver well-being. Results: The final 12-item PATT demonstrated robust psychometric properties, including high internal consistency (α = 0.82-0.90) and content validity. Convergent validity was established through significant correlations between PATT scores and behavioral engagement metrics. Conclusions: Our findings suggest that the PATT is a reliable, valid tool for capturing patient acceptability, offering a nuanced perspective on program, process, and impact-related experiences. Further validation studies are recommended to confirm the PATT's utility in broader applications.