Division of Palliative Medicine, Barnes Jewish College, Goldfarb School of Nursing, Washington University St Louis, Columbia, Missouri, USA.
Department of Human Development and Family Science, University of Missouri, Columbia, Missouri, USA.
J Pain Symptom Manage. 2021 Jun;61(6):1147-1154. doi: 10.1016/j.jpainsymman.2020.10.024. Epub 2020 Nov 6.
Hospice is a service for those with a life expectancy of six months or less. Family caregivers suffer from depression and anxiety as they care for their loved one until they die. Little is known about how research participants decide to consent to participate in clinical trials in the hospice setting.
This pilot study sought to answer two research questions: 1) In what way do demographic characteristics, mental health, and perceived caregiving experience impact the decision by caregivers to participate in hospice clinical trials? 2) In what ways do the perceived physical, psychological, economic, familial, and social dimensions of caregivers' lives influence their decision to participate in hospice clinical trials?
The characteristics and stated reasons for consent of hospice caregivers participating in a clinical trial were compared with individuals who refused clinical trial consent and only consented to this pilot study. Demographic, mental health, and perceptions of caregiving experience were measured as influencers to the consent decision. Recruitment calls were recorded and coded using framework analysis to identify perceived benefits and burdens impacting the decision to consent to the clinical trial.
Overall, trial participants were more often adult children to the patient (55% vs. 21%, P = 0.005), younger (56 vs. 63 years, P = 0.04), and employed (47% vs. 24%, P = 0.02) as compared with those who did not consent to participate in the trial. Reported levels of depression, anxiety, and quality of life were not significantly different between those who chose to participate in the clinical trial and those who participated only in this pilot study; however, caregiver burden was higher for those consenting to the clinical trial (4.05 vs. 7.16, P < 0.0001). Perceived benefits expressed by both groups were largely psychological as participants felt positive about contributing to science. Burdens expressed by both groups were predominately physical as they related to hesitation to participate in the intervention because of technology or the burdens of caregiving.
The benefits and burdens model for clinical trial participation is applicable to the caregiver experience in the hospice setting. Understanding the perceptions and dimensions of benefits and burdens to potential study participants is critical to not only the intervention design but also the tailoring of recruitment contacts and informed consent process.
临终关怀是为预期寿命不足六个月的人提供的服务。在照顾亲人直至亲人去世的过程中，家庭护理人员会遭受抑郁和焦虑。对于研究参与者如何决定同意参与临终关怀环境中的临床试验，人们知之甚少。
本试点研究旨在回答两个研究问题：1）人口统计学特征、心理健康和感知的护理经验如何影响护理人员参与临终关怀临床试验的决定？2）护理人员生活的身体、心理、经济、家庭和社会方面的感知如何影响他们参与临终关怀临床试验的决定？
将参与临床试验的临终关怀护理人员的特征和同意理由与拒绝临床试验同意但仅同意参与本试点研究的人员进行比较。人口统计学、心理健康和护理经验感知被测量为同意决定的影响因素。招募电话使用框架分析进行记录和编码，以确定影响同意参加临床试验的感知益处和负担。
总体而言，试验参与者更可能是患者的成年子女（55%比 21%，P=0.005），年龄较小（56 岁比 63 岁，P=0.04），并且就业（47%比 24%，P=0.02）与那些不同意参加试验的人相比。选择参加临床试验和仅参加本试点研究的人之间的抑郁、焦虑和生活质量报告水平没有显著差异；然而，同意参加临床试验的护理人员的护理人员负担更高（4.05 比 7.16，P<0.0001）。两组表达的感知益处主要是心理上的，因为参与者对为科学做出贡献感到积极。两组表达的负担主要是身体上的，因为他们因为技术或护理负担而对参与干预犹豫不决。
临床试验参与的益处和负担模型适用于临终关怀环境中的护理人员体验。了解潜在研究参与者的感知和益处及负担维度对于干预设计以及招募联系和知情同意过程的定制至关重要。
