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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
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.
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
Yes
Ro HQ
New York, New York, United States
Start Date
October 8, 2020
Primary Completion Date
November 16, 2020
Completion Date
November 16, 2020
Last Updated
June 8, 2023
2,000
ACTUAL participants
An automated patient-reported outcome data collection and adverse event surveillance tool
OTHER
Lead Sponsor
Ro
NCT06385457
NCT06197347
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