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临床试验/NCT05895539
NCT05895539已完成不适用

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

Ro1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2020年10月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Ro
入组人数
2,000
试验地点
1
主要终点
Odds of refilling prescription and percent of patients who refilled prescription for patients with an initial auto-refill plan of 1 month

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

研究组 & 干预措施

Intervention

Experimental

Did receive the tool

干预措施: An automated patient-reported outcome data collection and adverse event surveillance tool (Other)

Control

No Intervention

Did not receive the tool

结局指标

主要结局

Odds of refilling prescription and percent of patients who refilled prescription for patients with an initial auto-refill plan of 1 month

时间窗: 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

时间窗: 123 days

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

次要结局

未报告次要终点

研究者

发起方
Ro
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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