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

Not Applicable

Completed

• Conditions: Online Intervention; Internet-based Intervention; Erectile Dysfunction; Telemedicine; Web-based Intervention
• Interventions: Other: An automated patient-reported outcome data collection and adverse event surveillance tool

• Registration Number: NCT05895539
• Lead Sponsor: Ro

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-08
• Primary Completion: 2020-11-16
• Study Completion: 2020-11-16
• Status Verified: 2023-05
• Study First Submitted: 2023-05-08
• Study First Submitted QC: 2023-05-31
• Last Update Submitted: 2023-05-31
• Study First Posted: 2023-06-08
• Last Update Posted: 2023-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 2000

Inclusion Criteria

• Male patients living in the US, who were diagnosed with erectile dysfunction by a telehealth provider, and who were prescribed phosphodiesterase-5 (PDE-5) inhibitors as treatment

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	An automated patient-reported outcome data collection and adverse event surveillance tool	Did receive the tool

Primary Outcome Measures

Name	Time	Method
Odds of refilling prescription and percent of patients who refilled prescription for patients with an initial auto-refill plan of 1 month	91 days	Odds of refilling prescription (logistic regression); percent of patients who refilled prescription (log rank test from Kaplan Meier curve)
Odds of refilling prescription and percent of patients who refilled prescription for patients with an initial auto-refill plan of 3 months	123 days	Odds of refilling prescription (logistic regression); percent of patients who refilled prescription (log rank test from Kaplan Meier curve)

Trial Locations

Locations (1)

Ro HQ; 🇺🇸 New York, New York, United States