Conducting the ACTIVE randomized trial in hospice care: Keys to success
Conducting the ACTIVE randomized trial in hospice care: Keys to success
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DOI：
10.1177/1740774512461858
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发表时间：
2013-02-01
期刊：
影响因子：
2.7
通讯作者：
Demiris, George
中科院分区：
文献类型：
--
作者：
Kruse, Robin L.;Oliver, Debra Parker;Demiris, George
背景未治疗的疼痛是常见的患者在生命的尽头。非正式的护理人员，通常是病人的家人或朋友，负责与临终关怀工作人员合作，提供疼痛管理。每两周在临终关怀中心举行一次跨学科小组会议，为临终关怀工作人员提供一个机会，与临终关怀患者的非正式护理人员就疼痛管理进行沟通。目的我们提出挑战，解决方案，方法我们正在进行评估护理人员通过视频相遇进行团队干预（ACTIVE）本研究旨在确定临终关怀患者的非正式护理人员与临终关怀团队之间定期举行视频会议是否会改变护理人员对疼痛管理和患者疼痛的看法。参与者必须是临终关怀患者的主要照顾者，至少18岁，能够提供知情同意，并能够使用具有高速互联网连接的计算机或电话。我们将护理人员随机分为两组，一组通过视频或电话会议（干预）参加每两周一次的团队会议，另一组接受临终关怀的常规护理。所有患者接受标准的临终关怀，无论他们的非正式careful.Results组分配截至2012年7月1日，有1038个新的入院参与临终关怀。在391个没有接触的病例中，233名患者死亡或预期寿命不到14天。对271名有兴趣和符合条件的照顾者进行了家访; 233名患者的249名照顾者被随机分配到常规护理或干预组。对仪器和程序的全面试点测试帮助我们克服了在这一弱势群体中开展研究的障碍。成功的关键包括获得临终关怀医疗主任的支持，包括临终关怀工作人员在研究准备中，最大限度地减少临终关怀工作人员的负担，在每个参与临终关怀的研究人员中安置研究人员，使用时事通讯加强沟通，开发和维护详细的程序手册，定期制作数据质量报告，开发一个安全的网站，以方便编码定性研究的视频，并与主要工作人员定期举行电话会议。局限性许多病人在临终关怀中登记较晚，使他们的照顾者几乎没有时间参加干预。协助照顾者的患者非常短的预期寿命可能需要不同的methods.Conclusions进行随机试验与临终关怀患者和照顾者的挑战，可以解决与适当的研究设计，经过充分测试的研究方法，并积极主动地监测任何问题或问题。临床试验2012; 10：160-169 http://ctj.sagepub.com
Background Untreated pain is common for patients at the end of life. Informal caregivers, often family or friends of patients, are responsible for working with hospice staff to provide pain management. Interdisciplinary team meetings conducted in hospices every 2 weeks provide an opportunity for hospice staff to communicate about pain management with informal caregivers of hospice patients.Purpose We present challenges, solutions, and keys strategies for carrying out a randomized trial in the hospice setting.Methods We are conducting the Assessing Caregivers for Team Intervention through Video Encounters (ACTIVE) study to determine whether regular videoconferencing between hospice patients' informal caregivers and the hospice care team alters caregivers' perceptions of pain management and patients' pain. Participants must be primary caregivers for a hospice patient, at least 18 years of age, capable of providing informed consent, and have access to a computer with a high-speed Internet connection or a telephone. We randomized caregivers to participate in biweekly team meetings through video or phone conferencing (intervention) or to receive usual care from the hospice. All patients receive standard hospice care regardless of the group assignment of their informal caregiver.Results As of 1 July 2012, there have been 1038 new admissions to the participating hospices. Of 391 cases in which no contact was made, 233 patients had died or had life expectancy less than 14 days. Home visits were made to 271 interested and eligible caregivers; 249 caregivers of 233 patients were randomly assigned to the usual care or intervention arm. Enrollment is on pace to meet recruitment goals. Lessons Learned Thorough pilot testing of instruments and procedures helped us overcome barriers to conducting research in this vulnerable population. Keys to success included obtaining support from hospice medical directors, including hospice staff in study preparation, minimizing the burden on hospice staff, housing research staff in each participating hospice, using newsletters to enhance communication, developing and maintaining a detailed procedural manual, producing regular data quality reports, developing a secure site to facilitate coding videos for qualitative studies, and holding regular teleconferences with key staff.Limitations Late enrollment of many patients in hospice left little to no time for their caregivers to take part in the intervention. Assisting caregivers of patients with very short life expectancy may require different methods.Conclusions The challenges of conducting randomized trials with hospice patients and caregivers can be addressed with appropriate study design, well-tested research methods, and proactive monitoring of any issues or problems. Clinical Trials 2012; 10: 160-169 http://ctj.sagepub.com