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Clinical Trials/NCT05895539
NCT05895539
Completed
N/A

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

Ro1 site in 1 country2,000 target enrollmentOctober 8, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Internet-based Intervention
Sponsor
Ro
Enrollment
2000
Locations
1
Primary Endpoint
Odds of refilling prescription and percent of patients who refilled prescription for patients with an initial auto-refill plan of 1 month
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 8, 2020
End Date
November 16, 2020
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Ro
Responsible Party
Sponsor

Eligibility Criteria

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

  • Not provided

Outcomes

Primary Outcomes

Odds of refilling prescription and percent of patients who refilled prescription for patients with an initial auto-refill plan of 1 month

Time Frame: 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

Time Frame: 123 days

Odds of refilling prescription (logistic regression); percent of patients who refilled prescription (log rank test from Kaplan Meier curve)

Study Sites (1)

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