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

NCT05895539 | Completed

• 1 other identifier: 21-12-196-599
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Control

NO INTERVENTION

Did not receive the tool

Intervention

EXPERIMENTAL

Did receive the tool

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

Interventions

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Ro: lead

Study Sites (1)

Ro HQ

New York, New York, 10011, United States

Location

Related Publications (1)

• Zhou MS, Jain T, Hardy N, Perez-Segura A, Hickman J, Leopold L, Qualliotine K, Yedidi RS, Whetsell M, Broffman L. The design, implementation, and impact of an automated patient-reported outcome data collection and adverse event surveillance tool: a randomized trial. BMC Health Serv Res. 2023 Nov 20;23(1):1277. doi: 10.1186/s12913-023-10231-1.

  PMID: 37986191 DERIVED

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Lauren Broffman, PhD

  Ro

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: June 8, 2023
• Study Start: October 8, 2020
• Primary Completion: November 16, 2020
• Study Completion: November 16, 2020
• Last Updated: June 8, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)