Implementing Advanced Care Planning in the Routine Care for Acutely Admitted Patients in Geriatric Units: a Cluster Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 15
- 主要终点
- Implementation outcome study: Fidelity to the intervention model - Advanced Care Planning
研究概览
简要总结
This study will develop and evaluate a complex intervention to implement advance care planning for severely ill home-dwelling elderly acutely admitted to hospital, by using a cluster randomized design.
Twelve Norwegian acute geriatric hospital units will participate in the main study, each as one cluster. Of the twelve clusters, half will receive implementation support and training immediately, and the other half will receive similar support after the intervention period. The study includes 1) assessment of implementation outcomes (fidelity) in the participating units,2) health service and clinical outcomes including a) questionnaires to all staff in the units before and after the implementation period, questionnaires to attending clinicians and qualitative interviews with health personnel and local unit leaders b) questionnaires to patients and their relatives, patients records and data from central health registers and qualitative interviews with patients and relatives. Furthermore we will assess barriers and facilitators for advance care planning in 1) a wider health service context, and 2) at the national, regional and municipal level, and do economic analyses.
详细描述
Background:
Severely ill elderly patients and their relatives are often poorly involved in treatment and care decisions. Advance care planning is a well-documented tool to comply with the ethical and legal imperative to involve both the patient and their next of kin in the planning of current and future treatment and care. The overall aim of this project is to improve health services, user involvement and quality of life for severely ill elderly people living at home, and their relatives, in an efficient, sustainable and coordinated way, through better implementation of Advance care planning (ACP).
Setting: Twelve hospital wards providing care to acutely admitted elderly home-dwelling patients, either pure geriatric units or mixed units with specialists in geriatric medicine.
Research questions:
- What is the current level of implementation of ACP for home-dwelling elderly patients with severe somatic disease in the participating clinical units?
- What are the most important facilitators and barriers among all relevant stakeholders - to implementing ACP at the a) clinical, b) health care service- and c) national, regional and municipal level?
- What are the most important moral dilemmas and conflicting interests related to ACP, and how can these be resolved?
- What are the benefits and disadvantages with the implementation support and ACP experienced by the patients, among next of kin, health personnel and implementation teams?
- Does the implementation support program - compared to no such support - improve a) the implementation of ACP (fidelity), b) quality of communication and decision-making for patients and relatives when approaching the end of life, and c) congruence between the patient's preferences for information and involvement and the attending clinician's perceptions of the same, and other relevant outcomes for patients, relatives, and the attending clinicians?
- Is the implementation support program associated with changes in health personnel's perceptions, attitudes, self-efficacy, confidence in, and experiences in relation to information giving and involvement of patients and relatives?
- Is higher level of implementation (fidelity) of ACP associated with improved outcomes for patients, relatives, the staff and the services?
- Is the implementation support program for ACP a cost-effective intervention?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
No masking Patients and next-of-kin will not be informed about the hospital unit's allocation status. However, they may deduce this from the kind of intervention they receive. It's impossible to blind the care providers and for practical reasons we won't be able to blind the investigators or the outcomes assessors.
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Implementation outcome study: Fidelity to the intervention model - Advanced Care Planning
时间窗: Baseline, 9 and 18 months in the intervention arm. Baseline and 18 months in the control arm.
Change in fidelity (sum score) measured by the fidelity scale for Advanced Care Planning. Rated from 1 (low) to 5 (high).
Clinical effectiveness study 1: Patient-reported outcome
时间窗: During the intervention period (10-18 months after the start of the implementation support)
Quality of communication and decision-making when the patient is approaching the end of life. 4 items, scale 0-9.
Clinical effectiveness study 2: Relative-reported outcome
时间窗: During the intervention period (10-18 months after the start of the implementation support)
Quality of communication and decision-making for the patient and the next-of-kin when approaching the end of life. 4 items, rated 0-9.
Clinical effectiveness study 3: Clinician outcome
时间窗: During the intervention period (10-18 months after the start of the implementation support)
Congruence between the patient's preferences for information and involvement and the attending clinician's perceptions of the same, 4 items, scales: 0-9, 0-2, 0-9, 7 alternative answers, respectively
次要结局
- Clinical effectiveness study 1: Patient-reported seondary outcome 3(During the intervention period (10-18 months after the start of the implementation support))
- Clinical effectiveness study 1: Patient-reported seondary outcome 6(During the intervention period (10-18 months after the start of the implementation support))
- Implementation outcome study: Fidelity to the intervention model - Advanced Care Planning 2(Baseline, 9 and 18 months in the intervention arm. Baseline and 18 months in the control arm.)
- Clinical effectiveness study 1: Patient registry data 1 - Number of hospital admissions(From 18 months before to 18 months after inclusion (or until death))
- Clinical effectiveness study 1: Patient health records data(From 18 months before to 18 months after inclusion (or until death))
- Clinical effectiveness study 2: Relative-reported seondary outcome 2(During the intervention period (10-18 months after the start of the implementation support))
- Implementation outcome study: Fidelity to the intervention model - Advanced Care Planning 1(Baseline, 9 and 18 months in the intervention arm. Baseline and 18 months in the control arm.)
- Implementation outcome study: Fidelity to the intervention model - Advanced Care Planning 3(Baseline, 9 and 18 months in the intervention arm. Baseline and 18 months in the control arm.)
- Clinical effectiveness study 1: Patient-reported seondary outcome 2(During the intervention period (10-18 months after the start of the implementation support))
- Clinical effectiveness study 2: Relative-reported seondary outcome 7(During the intervention period (10-18 months after the start of the implementation support))
- Clinical effectiveness study 4: All staff - 1(Baseline and 18 months in both intervention and control arm)
- Clinical effectiveness study 4: All staff - 2(Baseline and 18 months in both intervention and control arm)
- Clinical effectiveness study 2: Relative-reported seondary outcome 1(During the intervention period (10-18 months after the start of the implementation support))
- Clinical effectiveness study 2: Relative-reported seondary outcome 3(During the intervention period (10-18 months after the start of the implementation support))
- Clinical effectiveness study 1: Patient-reported seondary outcome 1(During the intervention period (10-18 months after the start of the implementation support))
- Clinical effectiveness study 1: Patient-reported seondary outcome 4(During the intervention period (10-18 months after the start of the implementation support))
- Clinical effectiveness study 1: Patient-reported seondary outcome 5(During the intervention period (10-18 months after the start of the implementation support))
- Clinical effectiveness study 1: Patient registry data 2 - Other use of health care services and use of medication(From 18 months before to 18 months after inclusion (or until death))
- Clinical effectiveness study 1: Patient registry data 3 - Time before death (for patients dying before 18 months after inclusion)(From inclusion to 18 months after inclusion)
- Clinical effectiveness study 2: Relative-reported seondary outcome 5(During the intervention period (10-18 months after the start of the implementation support))
- Clinical effectiveness study 4: All staff - 5(Baseline and 18 months in both intervention and control arm.)
- Clinical effectiveness study 2: Relative-reported seondary outcome 4(During the intervention period (10-18 months after the start of the implementation support))
- Clinical effectiveness study 3: Clinician secondary outcome 1(During the intervention period (10-18 months after the start of the implementation support))
- Clinical effectiveness study 4: All staff - 3(Baseline and 18 months in both intervention and control arm)
- Clinical effectiveness study 4: All staff - 4(Baseline and 18 months in both intervention and control arm)
- Economic sub-study: Increased costs related to implementing and practicing ACP(Measured before baseline and then throughout the implementation period (0-18 months).)
- Clinical effectiveness study 2: Relative-reported seondary outcome 6(During the intervention period (10-18 months after the start of the implementation support))
- Clinical effectiveness study 3: Clinician secondary outcome 2(During the intervention period (10-18 months after the start of the implementation support))
研究者
Reidar Pedersen
Professor
University of Oslo