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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-08

Study Completion Date

2020-11-16

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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control

Did not receive the tool

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

Did receive the tool

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

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