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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Telemedicine, Internet-based Intervention, Web-based Intervention, Online Intervention, Erectile Dysfunction

Intervention / Treatment
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* Other: An automated patient-reported outcome data collection and adverse event surveillance tool


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Did not receive the tool | |
| Experimental: Intervention<br>Did receive the tool | Other: An automated patient-reported outcome data collection and adverse event surveillance tool<br>* Patients received a short prompt to provide information on treatment satisfaction and side effects<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |