search
Back to results

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

Primary Purpose

Internet-based Intervention, Web-based Intervention, Online Intervention

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
An automated patient-reported outcome data collection and adverse event surveillance tool
Sponsored by
Ro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Internet-based Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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: -

Sites / Locations

  • Ro HQ

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

Did not receive the tool

Did receive the tool

Outcomes

Primary Outcome Measures

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)
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)

Secondary Outcome Measures

Full Information

First Posted
May 8, 2023
Last Updated
May 31, 2023
Sponsor
Ro
search

1. Study Identification

Unique Protocol Identification Number
NCT05895539
Brief Title
Evaluating Treatment Continuation in Telehealth Patients Receiving an Automated Patient-Reported Outcome Tool
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
October 8, 2020 (Actual)
Primary Completion Date
November 16, 2020 (Actual)
Study Completion Date
November 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ro

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Internet-based Intervention, Web-based Intervention, Online Intervention, Erectile Dysfunction, Telemedicine

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Did not receive the tool
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Did receive the tool
Intervention Type
Other
Intervention Name(s)
An automated patient-reported outcome data collection and adverse event surveillance tool
Intervention Description
Patients received a short prompt to provide information on treatment satisfaction and side effects
Primary Outcome Measure Information:
Title
Odds of refilling prescription and percent of patients who refilled prescription for patients with an initial auto-refill plan of 1 month
Description
Odds of refilling prescription (logistic regression); percent of patients who refilled prescription (log rank test from Kaplan Meier curve)
Time Frame
91 days
Title
Odds of refilling prescription and percent of patients who refilled prescription for patients with an initial auto-refill plan of 3 months
Description
Odds of refilling prescription (logistic regression); percent of patients who refilled prescription (log rank test from Kaplan Meier curve)
Time Frame
123 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren Broffman, PhD
Organizational Affiliation
Ro
Official's Role
Study Director
Facility Information:
Facility Name
Ro HQ
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We are not planning to share IPD at this time, due to concerns around patient privacy.

Learn more about this trial

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

We'll reach out to this number within 24 hrs