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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Did not receive the tool | |
| Intervention | Experimental | Did receive the tool |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lauren Broffman, PhD | Ro | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ro HQ | New York | New York | 10011 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37986191 | Derived | 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. |
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We are not planning to share IPD at this time, due to concerns around patient privacy.
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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