Effect of Advance Care Planning to Improve Patient-centered Care of Nursing Home Residents: Cluster-randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5,927
- 试验地点
- 4
- 主要终点
- Change of hospital admissions
研究概览
简要总结
Advance Care Planning (ACP) is an approach to support individuals in understanding and sharing their values, treatment goals, and preferences regarding future medical care. This study aims to evaluate the clinical effectiveness of implementing a complex regional ACP program focussing on nursing homes and their related health care providers.
For this purpose, a cluster-randomised controlled trial (cRCT) is being conducted in four study centres in Germany: Düsseldorf, Göttingen, Halle (Saale), and Munich. 44 nursing homes with 3,520 residents will be randomised into either an intervention group, receiving the ACP-intervention described below, or into a control group that will receive usual care.
The complex ACP intervention comprises training of professional ACP facilitators (micro level), supporting organisational development in nursing homes and other relevant institutions (meso level), and moderating regional change management among a network of all related health care institutions and actors (macro level).
Clinical outcomes will be measured in order to describe whether the intervention improved care consistency with care preferences.
Data will be collected by two independent approaches:
Firstly, participating nursing homes will provide anonymous data on all their long-term care residents of a defined time period, including the hospitalisation rate (primary outcome). The primary hypothesis will test whether the complex intervention reduces the rate of hospital admissions. A group comparison of all hospitalisations in the past 12 months is made 21 months after randomisation.
Secondly, all residents who have given informed consent in the first three months of the study will be repeatedly surveyed until month 21 (or until they die earlier). Treatment decisions in the face of life-threatening illness that affect any of a list of pre-defined outcomes will be evaluated as to whether they were consistent with the residents' care preferences.
If residents decease, patient-centered care in the last weeks of life will be evaluated by additional interviews with the next bereaved relative, and an involved nurse. Besides, bereaved relatives will be assessed for trauma, depression and anxiety.
In addition, a process evaluation and a health economic evaluation are carried out according to Medical Research Council (MRC) recommendations.
详细描述
Aim of the study:
The aim of the study is to evaluate the effect of a complex regional Advance Care Planning (ACP) intervention on care consistency with residents' care preferences in the face of potentially life-threatening disease.
Study design:
Multi-center cluster-randomised controlled trial (cRCT) to evaluate the clinical effects of regional implementation of a complex German ACP program (confer www.div-bvp.de) focussing on nursing homes and related health care providers. 44 nursing homes (clusters) with a mean of 80 residents (observation units) each will be randomised into intervention (ACP implementation) and control (usual care) groups.
Randomization:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
- Investigators will be blinded towards group allocation. There is as risk of unblinding of investigators, therefore we will determine true blinding status at follow-up.
- Outcomes Assessors will be consequently blinded with regard to group assignment until the statistical analysis plan is finalized.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •all long-term care residents of the enrolled nursing homes
排除标准
- 未提供
结局指标
主要结局
Change of hospital admissions
时间窗: 21 months
Number of hospital admission per 100 residents
次要结局
- Change in the number of process parameters indicating valid ACP: advance care plans(21 months)
- Change of hospital days(21 months)
- Change in the number of pre-specified unwanted invasive treatments(21 months)
- Change in the rate of hospital as last place of care(21 months)
- Change in the perception of concordance(21 months)
- Change in the number of process parameters indicating valid ACP: proxy designations(21 months)
- Change in anxiety, depression and trauma among bereaved relatives(21 months)
- Change in the number of residents whose preferences were (a) known and (b) followed in the face of potentially life-threatening events(21 months)
研究者
Prof. Dr. Jürgen in der Schmitten, MD
Professor Jürgen in der Schmitten, MD, PhD, MPH
Heinrich-Heine University, Duesseldorf