Institute of General Practice, Medical Faculty, Heinrich Heine University Düsseldorf, Düsseldorf, Germany.
Department of Palliative Medicine, Munich University Hospital, Munich, Germany.
Trials. 2022 Sep 12;23(1):770. doi: 10.1186/s13063-022-06576-3.
According to recent legislation, facilitated advance care planning (ACP) for nursing home (NH) residents is covered by German sickness funds. However, the effects of ACP on patient-relevant outcomes have not been studied in Germany yet. This study investigates whether implementing a complex regional ACP intervention improves care consistency with care preferences in NH residents.
This is a parallel-group cluster-randomized controlled trial (cRCT) with 48 NHs (≈ 3840 resident beds) between 09/2019 and 02/2023. The intervention group will receive a complex, regional ACP intervention aiming at sustainable systems redesign at all levels (individual, institutional, regional). The intervention comprises comprehensive training of ACP facilitators, implementation of reliable ACP processes, organizational development in the NH and other relevant institutions of the regional healthcare system, and education of health professionals caring for the residents. Control group NHs will deliver care as usual. Primary outcome is the hospitalization rate during the 12-months observation period. Secondary outcomes include the rate of residents whose preferences were known and honored in potentially life-threatening events, hospital days, index treatments like resuscitation and artificial ventilation, advance directives, quality of life, psychological burden on bereaved families, and costs of care. The NHs will provide anonymous, aggregated data of all their residents on the primary outcome and several secondary outcomes (data collection 1). For residents who have given informed consent, we will evaluate care consistency with care preferences and further secondary outcomes, based on chart reviews and short interviews with residents, surrogates, and carers (data collection 2). Process evaluation will aim to explain barriers and facilitators, economic evaluation the cost implications.
This study has the potential for high-quality evidence on the effects of a complex regional ACP intervention on NH residents, their families and surrogates, NH staff, and health care utilization in Germany. It is the first cRCT investigating a comprehensive regional ACP intervention that aims at improving patient-relevant clinical outcomes, addressing and educating multiple institutions and health care providers, besides qualification of ACP facilitators. Thereby, it can generate evidence on the potential of ACP to effectively promote patient-centered care in the vulnerable population of frail and often chronically ill elderly.
ClinicalTrials.gov ID NCT04333303 . Registered 30 March 2020.
根据最近的立法，为养老院（NH）居民提供便利的预先护理计划（ACP）已被德国医保覆盖。然而，ACP 对患者相关结局的影响在德国尚未得到研究。本研究旨在探讨实施复杂的区域性 ACP 干预是否能提高 NH 居民护理的一致性，使其与护理偏好相符。
这是一项在 2019 年 9 月至 2023 年 2 月期间进行的平行组聚类随机对照试验（cRCT），共有 48 家 NH（约 3840 张床位）参与。干预组将接受一项复杂的区域性 ACP 干预，旨在各级别（个人、机构、地区）实现可持续的系统重新设计。该干预包括全面培训 ACP 促进者、实施可靠的 ACP 流程、在 NH 及区域医疗系统的其他相关机构开展组织发展、以及对照顾居民的卫生专业人员进行教育。对照组的 NH 将提供常规护理。主要结局是 12 个月观察期内的住院率。次要结局包括在潜在危及生命的事件中，已知和尊重居民偏好的居民比例、住院天数、复苏和人工通气等指数治疗、预先指示、生活质量、丧亲家庭的心理负担，以及护理成本。NH 将提供所有居民的主要结局和若干次要结局的匿名、汇总数据（数据收集 1）。对于已给予知情同意的居民，我们将基于病历回顾和对居民、代理人和照顾者的简短访谈，评估护理与偏好的一致性和其他次要结局（数据收集 2）。过程评估旨在解释障碍和促进因素，经济评估则关注成本影响。
本研究有潜力提供高质量证据，说明复杂的区域性 ACP 干预对德国 NH 居民、其家属和代理人、NH 工作人员以及医疗保健利用的影响。这是第一项调查全面区域性 ACP 干预的 cRCT，该干预旨在改善患者相关的临床结局，涉及并教育多个机构和卫生保健提供者，同时也对 ACP 促进者进行培训。因此，它可以为 ACP 有效促进弱势人群（体弱且经常患有慢性病的老年人）的以患者为中心的护理提供证据。
ClinicalTrials.gov 标识符 NCT04333303。于 2020 年 3 月 30 日注册。
