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临床试验/NCT06013176
NCT06013176已完成不适用

Behavioral Economic Strategies to Improve PRO Adherence

Abramson Cancer Center at Penn Medicine4 个研究点 分布在 1 个国家目标入组 476 人开始时间: 2023年12月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
476
试验地点
4
主要终点
PRO Adherence

研究概览

简要总结

The main purpose of this research study is to evaluate the implementation and effectiveness of patient- and nurse-directed strategies across in-clinic and remote patient reported outcome (PRO) monitoring settings, using a three-arm pragmatic cluster randomized controlled trial. Additionally, the goal is to evaluate moderators of implementation effects on PRO monitoring.

Eligible patients will be randomized independently to: (1) usual practice (i.e., encounter-based PRO administration via patient portal or tablet); (2) encounter-based PRO monitoring with patient reminders and nurse alerts; or (3) remote PRO monitoring with patient reminders and nurse alerts. The investigators hypothesize that nudges to patients and alerts to nurses will improve patient-level PRO completion and clinician-level PRO engagement.

详细描述

Routine PRO monitoring is an evidence-based practice that improves patient outcomes. Patients with cancer commonly experience symptoms which go unrecognized by clinical teams up to half of the time. PROs are a powerful tool to bridge this gap, amplifying the patient experience and improving communication between patients and clinicians. A seminal clinical trial was conducted in which weekly PRO symptom assessments with care team alerts led to reduced care utilization, improved quality of life, and lengthened overall survival among patients receiving active treatment for advanced solid tumors. Subsequent randomized trials have corroborated the quality of life and survival advantages of PRO monitoring in other cancer populations and practice settings.

Real-world adherence to PRO monitoring is lower than in seminal clinical trials, with potential racial/ethnic disparities. Multilevel barriers to PRO implementation exist at the patient, clinician, practice, and system levels. While patient adherence to PRO monitoring in seminal trials ranged from 70 to 90 percent, real-world adherence is much lower and more variable. Our preliminary research demonstrates that in a large, multi-site rollout of PRO monitoring, mean patient-level adherence was less than 50 percent. Moreover, compared to non-Hispanic White patients, Black and Hispanic patients were 9% and 4% less likely to complete PRO questionnaires, respectively, but more likely to report more severe symptoms. These results highlight that historically marginalized subgroups may benefit less from current methods of PRO administration, potentially reinforcing existing disparities in symptom management if not remediated.

This will be the first study to apply behavioral economic strategies to align clinicians and patients in achieving sustained patient-level PRO adherence, and addresses limitations of current PRO approaches. Current approaches to PRO collection are limited by: (1) suboptimal clinician engagement, (2) encounter-based assessments which preclude longitudinal monitoring of PROs outside of the clinic, and (3) insufficient automated effectors actively linking reported symptoms with clinical response. This proposal addresses these limitations by employing behavioral strategies directly targeting clinician engagement, utilizing novel electronic remote monitoring methods to maximize real-time PRO capture, and linking these with pathway-driven automated effectors.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Investigator)

入排标准

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

入选标准

  • Patients must initiate a new line of systemic cancer therapy (i.e., intravenous chemotherapy or immunotherapy) at a participating Implementation Lab site

排除标准

  • - Patient opts out of pragmatic research

结局指标

主要结局

PRO Adherence

时间窗: 3 months

The primary outcome will be PRO adherence, measured at the patient level as the proportion of expected PRO questionnaires completed per patient.

次要结局

  • Percent of Patients With at Least One Note Documenting PROs During Study Period(3 months)
  • Percent of Patients With at Least One Note Documenting PROs Per Month During Study Period(3 months)
  • Time to Alert Response (for Arms 2 and 3 Only)(3 months)
  • Percent of Patients Who Trigger an Alert for Triage Nurses (for Arms 2 and 3 Only)(3 months)
  • Acute Care Utilization(3 months)
  • Treatment Modifications(3 months)
  • Duration of Therapy(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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