Romøren Maria, Hermansen Karin Berg, Sævareid Trygve Johannes Lereim, Brøderud Linn, Westbye Siri Færden, Wahl Astrid Klopstad, Thoresen Lisbeth, Rostoft Siri, Førde Reidun, Ahmed Marc, Aas Eline, Midtbust May Helen, Pedersen Reidar
Centre for Medical Ethics, Institute of Health and Society, University of Oslo, Oslo, Norway.
Department of General Practice, Institute of Health and Society, University of Oslo, Oslo, Norway.
BMC Health Serv Res. 2024 Feb 19;24(1):220. doi: 10.1186/s12913-024-10666-0.
Acutely ill and frail older adults and their next of kin are often poorly involved in treatment and care decisions. This may lead to either over- or undertreatment and unnecessary burdens. The aim of this project is to improve user involvement and health services for frail older adults living at home, and their relatives, by implementing advance care planning (ACP) in selected hospital wards, and to evaluate the clinical and the implementation interventions.
This is a cluster randomized trial with 12 hospital units. The intervention arm receives implementation support for 18 months; control units receive the same support afterwards. The ACP intervention consists of 1. Clinical intervention: ACP; 2. Implementation interventions: Implementation team, ACP coordinator, network meetings, training and supervision for health care personnel, documentation tools and other resources, and fidelity measurements with tailored feedback; 3. Implementation strategies: leadership commitment, whole ward approach and responsive evaluation. Fidelity will be measured three times in the intervention arm and twice in the control arm. Here, the primary outcome is the difference in fidelity changes between the arms. We will also include 420 geriatric patients with one close relative and an attending clinician in a triadic sub-study. Here, the primary outcomes are quality of communication and decision-making when approaching the end of life as perceived by patients and next of kin, and congruence between the patient's preferences for information and involvement and the clinician's perceptions of the same. For patients we will also collect clinical data and health register data. Additionally, all clinical staff in both arms will be invited to answer a questionnaire before and during the implementation period. To explore barriers and facilitators and further explore the significance of ACP, qualitative interviews will be performed in the intervention units with patients, next of kin, health care personnel and implementation teams, and with other stakeholders up to national level. Lastly, we will evaluate resource utilization, costs and health outcomes in a cost-effectiveness analysis.
The project may contribute to improved implementation of ACP as well as valuable knowledge and methodological developments in the scientific fields of ACP, health service research and implementation science.
ClinicalTrials.gov Identifier NCT05681585. Registered 03.01.23.
急性病患者及体弱的老年人及其近亲往往很少参与治疗和护理决策。这可能导致过度治疗或治疗不足以及不必要的负担。本项目的目的是通过在选定的医院病房实施预先护理计划（ACP），改善居家体弱老年人及其亲属的用户参与度和健康服务，并评估临床干预措施和实施干预措施。
这是一项针对12个医院科室的整群随机试验。干预组接受为期18个月的实施支持；对照组随后接受相同的支持。ACP干预措施包括：1. 临床干预：ACP；2. 实施干预：实施团队、ACP协调员、网络会议、医护人员培训及监督、文档工具和其他资源，以及有针对性反馈的保真度测量；3. 实施策略：领导承诺、全病房方法和响应式评估。将对干预组进行三次保真度测量，对对照组进行两次保真度测量。在此，主要结局是两组之间保真度变化的差异。我们还将在一项三方子研究中纳入420名老年患者及其一名近亲以及一名主治医生。在此，主要结局是患者及其近亲在接近生命末期时的沟通质量和决策质量，以及患者对信息和参与的偏好与医生的认知之间的一致性。对于患者，我们还将收集临床数据和健康登记数据。此外，两组的所有临床工作人员都将被邀请在实施期之前和期间回答一份问卷。为了探究障碍和促进因素，并进一步探究ACP的意义，将在干预科室对患者、近亲、医护人员和实施团队以及直至国家层面的其他利益相关者进行定性访谈。最后，我们将在成本效益分析中评估资源利用、成本和健康结局。
该项目可能有助于改善ACP的实施，以及在ACP、卫生服务研究和实施科学等科学领域积累宝贵的知识和方法进展。
ClinicalTrials.gov标识符NCT05681585。于2023年1月3日注册。
