NCT05895539

Evaluating Treatment Continuation in Telehealth Patients Receiving an Automated Patient-Reported Outcome Tool

The Design, Implementation, and Impact of Automated Patient-reported Outcome Data Collection and Adverse Event Surveillance Tool on Treatment Continuation: an Iterative Plan-Do-Study-Act (PDSA) Approach

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,000 (actual)
• Sponsor: Ro · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Engaging patients through integration of patient-reported outcome measures in routine clinical care can improve the patient experience and provide a systematic way to collect adverse event (AE) data. Collecting these data on a large scale can inform new solutions to longstanding barriers to successful treatment such as medication non-adherence. This study evaluated whether implementing a patient-reported outcome data collection and AE surveillance tool would result in greater treatment continuation for patients receiving care on a telehealth platform. We evaluated how this data collection and surveillance tool - a short prompt for patients to provide information on treatment satisfaction and side effects - impacted the outcome of interest, treatment continuation. We tested two cycles in n=2,000 patients receiving care for erectile dysfunction on a telehealth platform using a randomized control experimental design and accounted for incidents where true randomization was not possible during implementation. The first cycle tested the tool alone, while the second cycle tested the tool in conjunction with a messaging template system that provided standardized side effect counseling.

Conditions

• Internet-based Intervention
• Web-based Intervention
• Online Intervention
• Erectile Dysfunction
• Telemedicine

Interventions

Type	Name	Description
OTHER	An automated patient-reported outcome data collection and adverse event surveillance tool	Patients received a short prompt to provide information on treatment satisfaction and side effects

Timeline

• Start date: 2020-10-08
• Primary completion: 2020-11-16
• Completion: 2020-11-16
• First posted: 2023-06-08
• Last updated: 2023-06-08

Locations

1 site across 1 country: United States