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临床试验/NCT04867850
NCT04867850已完成不适用

Effect of Behavioral Nudges to Clinicians, Patients, or Both on Serious Illness Conversation Documentation for Patients With Cancer

Abramson Cancer Center at Penn Medicine2 个研究点 分布在 1 个国家目标入组 4,450 人开始时间: 2021年9月9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
4,450
试验地点
2
主要终点
Number of High Risk Patients With Documentation of a Serious Illness Conversation (SIC)

研究概览

简要总结

The main purpose of this research study is to evaluate the effectiveness of "nudges" to clinicians, to patients, or to both in increasing Serious Illness Conversation (SIC) documentation; and to identify moderators of implementation effects on SIC documentation. The investigators will employ rapid-cycle approaches to optimize the framing of nudges to clinicians and patients prior to initiating the trial and mixed methods to explore contextual factors and mechanisms.

The investigators will conduct a four-arm pragmatic cluster randomize clinical trial to test the effectiveness of nudges to clinicians, nudges to patients, or nudges to both in increasing the frequency and timeliness of SIC documentation in cancer patients vs. usual care (UC). The investigators hypothesize that each of the implementation strategy arms will significantly increase SIC documentation compared to UC and that the combination of nudges to clinicians and to patients will be the most effective.

详细描述

Patients with cancer often experience physical and emotional distress, utilize unplanned acute care, and undergo medical interventions that are discordant with their wishes. Given the Covid-19 pandemic, these adverse outcomes are amplified, particularly for racial/ethnic minorities. Serious illness conversations (SICs) that elicit patients' values, goals, and care preferences, particularly early in the disease trajectory, are an evidence-based practice, improve patient mood and quality of life, and are recommended by national guidelines. Preliminary data suggests that SICs among patients with cancer are associated with improved quality of life, increased hospice utilization, and decreased acute care utilization. However, most patients with advanced cancer die without a documented SIC and there are well-documented health disparities in implementation for racial and ethnic minorities. Current strategies to promote SICs, including the multi-component strategies of the Serious Illness Conversation Program, focus primarily on clinician education and have marginally increased the timeliness and frequency of SICs and reduced patient anxiety and depression. While core elements of this program are transferable-such as its structured guide-clinical use remains low. For example, even after training, clinicians at Penn Medicine document SICs for fewer than 5% of patients with advanced cancer. There is critical need to develop, test, and disseminate strategies to improve the frequency of SICs.

Implementation strategies informed by behavioral economics are ideally suited to address this problem, which is fundamentally one of clinician and patient behavior change. Clinician barriers to initiating SICs include optimism bias, or the belief that one's own patient is unlikely to experience a negative event; uncertainty about prognosis and appropriate timing; and fear that bringing up end-of-life issues may be distressing to patients. Patient barriers to SIC initiation include fear of discussing the end of life and beliefs that SICs are not appropriate until late in the course of cancer. While previous studies have tested financial incentives for SIC documentation, little research has evaluated behavioral economics-informed strategies to align both clinicians and patients towards earlier SICs.

By intentionally modifying the way choices are framed, behavioral nudges can lead to desirable changes in clinician behavior while preserving clinician choice. The investigators' preliminary work demonstrates the effectiveness of an implementation strategy focusing on a clinician nudge, consisting of performance feedback and targeted text messages identifying patients at high risk of mortality based on a validated machine learning prognostic algorithm. This strategy led to a threefold increase in SIC documentation for high-risk patients, equitably across racial/ethnic minority subgroups, and is now in routine use across Penn Medicine practice sites. However, clinicians still did not document SICs for over half of patients, illustrating the limitations of a clinician-directed implementation strategy alone.

This study will expand on these preliminary findings to evaluate the synergy between clinician- and patient-directed nudges to increase SIC documentation. The main purpose of this research study is to evaluate the effectiveness of nudges to clinicians, to patients, or to both in increasing Serious Illness Conversation (SIC) documentation; and to identify moderators of implementation effects on SIC documentation. The investigators will employ rapid-cycle approaches to optimize the framing of nudges to clinicians and patients prior to initiating the trial and mixed methods to explore contextual factors and mechanisms. The investigators will conduct a four-arm pragmatic cluster randomize clinical trial to test the effectiveness of nudges to clinicians, nudges to patients, or nudges to both in increasing the frequency and timeliness of SIC documentation in cancer patients vs. usual care (UC).

Rationale for clinician nudge using mortality prediction and peer comparison: Due to optimism bias, clinicians routinely overestimate the life expectancy of patients with advanced cancer and delay SICs until too late in the disease course. In part because of this, clinicians reinforce a social norm that early SICs are not part of routine oncology care. Providing an objective assessment of predicted mortality risk may help counteract optimism bias among clinicians and help them identify patients most likely to benefit from SICs. Moreover, that individuals desire to conform to an approved behavior (an injunctive norm) and the behavior of others (a descriptive norm) may contribute to low observed SIC rates, and may also afford an opportunity for intervention. The investigators expect that periodically reminding clinicians of their own performance on SIC documentation, while providing both an injunctive norm (citing national and institutional guidelines) and a descriptive social norm (displaying the behavior of their best performing peers), will lead clinicians to conform more closely to these norms, as has been shown in studies conducted in other contexts.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
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

  • Clinician (M.D., P.A., or N.P.) participants must meet the following criteria:
  • Provide care at least 1 clinic session per week for adult (age>18 years) patients with solid, hematologic, or gynecologic malignancies at a participating PennMedicine Implementation Lab site
  • Patient participants must meet the following criteria:
  • Receive care for a solid, hematologic, or gynecologic malignancy from an eligible provider at a participating PennMedicine Implementation Lab site
  • Have at least one scheduled Return Patient Visit (either in person or via telemedicine) with an eligible PennMedicine provider during the study period

排除标准

  • Clinicians will be ineligible for *any* of the following reasons:
  • Provide exclusively benign hematology, survivorship, and/or genetics care
  • Patients will be ineligible for *any* of the following reasons:
  • Previously documented SIC within 6 months
  • Have a non-valid phone number

结局指标

主要结局

Number of High Risk Patients With Documentation of a Serious Illness Conversation (SIC)

时间窗: Within 6 months of the Index Visit (baseline)

Measured at the patient level as a binary outcome (yes/no) among high-risk patients based on date of documented note including the SIC template in the Advanced Care Planning (ACP) section of the electronic medical record by any provider Outcomes were measured for patients only.

次要结局

  • Number of High Risk Patients With a Palliative Care Referral(Within 6 months of the Index Visit (baseline))
  • Number of Patients With SIC Documentation (Out of All Patients, Regardless of Risk Level)(Within 6 months of first repeat patient visit during trial period)
  • Number of Decedent High Risk Patients Who Received Aggressive End-Of-Life Care(Within 6 months of the Index Visit (baseline))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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