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

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.

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Key information

Conditions

Internet-based Intervention Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Online Intervention Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Telemedicine Urogenital Diseases Web-based Intervention

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Ro HQ

New York, 10011, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

An automated patient-reported outcome data collection and adverse event surveillance tool

Other

Patients received a short prompt to provide information on treatment satisfaction and side effects

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)

Sponsors and collaborators

Lead sponsor

Industry

Registry information

Official study 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

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Jun 8, 2023
Registry last updated: Jun 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed