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

Sponsor

Ro (Industry)

Overall Status

Completed

CT.gov ID

NCT05895539

Collaborator

(none)

2,000

Enrollment

Location

Arms

1.3

Actual Duration (Months)

1560.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Internet-based Intervention Web-based Intervention Online Intervention Erectile Dysfunction Telemedicine	Other: An automated patient-reported outcome data collection and adverse event surveillance tool	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

2000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Oct 8, 2020

Actual Primary Completion Date :

Nov 16, 2020

Actual Study Completion Date :

Nov 16, 2020

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Did not receive the tool
Experimental: Intervention Did receive the tool	Other: 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

Arm

Intervention/Treatment

No Intervention: Control

Did not receive the tool

Experimental: Intervention

Did receive the tool

Other: 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

Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ro HQ	New York	New York	United States	10011

Sponsors and Collaborators

Investigators

Study Director: Lauren Broffman, PhD, Ro

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

ClinicalTrials.gov Identifier:

NCT05895539

Other Study ID Numbers:

21-12-196-599

First Posted:

Jun 8, 2023

Last Update Posted:

Jun 8, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Erectile Dysfunction

Study Results

No Results Posted as of Jun 8, 2023