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

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05895539
• Other study ID #: 21-12-196-599
• Status: Completed
• Phase: N/A
• Start date: October 8, 2020
• Est. completion date: November 16, 2020

Study information

• Verified date: May 2023
• Source: Ro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: November 16, 2020
• Est. primary completion date: November 16, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	Ro HQ	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Ro

Country where clinical trial is conducted

United States, 

Outcome

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