Advance Care Planning in Nursing Homes in Flanders, a Cluster Randomized Controlled Trial and Process Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 684
- 试验地点
- 2
- 主要终点
- Change in knowledge of and self-efficacy concerning ACP
研究概览
简要总结
Advance care planning (ACP) is a process that supports adults at any age or stage of health in understanding and sharing their personal values, life goals, and preferences regarding future (medical) care. ACP is of particular relevance for frail older adults, particularly in the nursing home setting where an important proportion of older people die. However, the actual implementation of ACP in nursing home practice seems to be a challenge in many countries worldwide, and people often do not get the opportunity to discuss their preferences in advance. This study evaluates the effectiveness of a theory-based advance care planning training programme (ACP+ programme) for nursing homes in Flanders, Belgium, using a cluster randomised controlled trial (cRCT) design. The ACP+ programme aims to integrate ACP in routine nursing home care by training the nursing home staff and management. Residents and their family will receive in-depth information on ACP and participate in one or several ACP conversations, if they wish so.
Who can participate? Nursing homes that conform to the eligibility criteria: at least 100 beds, situated in Flanders and did not participate in a similar research or implementation project over the last 4 years.
What does the study involve? The researchers will perform a cluster randomized controlled trial (cRCT) to evaluate the effects of an ACP training programme in nursing homes in Flanders (Belgium), accompanied by a process evaluation. Fourteen nursing homes will be randomized to either the intervention group, which will receive the intervention (ACP+ programme), or the control group, in which no additional training regarding ACP (other than that which is part of routine practice) will be provided. The nursing homes in the control group will receive a short training on ACP, as well as all training materials used in the intervention after the last follow-up measurements.
At month 0 the researchers will perform a baseline measurement in the intervention and control groups using structured questionnaires to be filled in by all care staff in the nursing home. At the end of month 8, the same questionnaires will be administered again in all nursing homes (follow-up). The process evaluation will employ structured diaries for ACP trainers, attendance lists for training sessions, audiotaping of a sample of ACP conversations and individual and group interviews with staff and management of the intervention homes.
Hypotheses The primary hypothesis is that the introduction of the ACP+ programme in nursing homes will improve the knowledge and self-efficacy of nursing home care staff regarding advance care planning.
详细描述
Study hypothesis The primary study hypothesis is that the introduction of the ACP+ programme in nursing homes will improve the knowledge and self-efficacy of nursing home care staff regarding advance care planning (ACP).
Ethics approval The study was approved by the Ethics committee of University Hospital Brussels (Vrije University Brussels, 22/02/2018, ref: 18-003 - B.U.N. 143201834759)
Study design A cluster randomized controlled trial using baseline and follow-up measurement of relevant outcome variables and process evaluation. The trial will be implemented in a sample of 14 nursing homes (see eligibility criteria below) randomised to either intervention or control group.
Trial duration The duration of the entire trial, from the moment the first nursing home is recruited until the end of follow up will be 10 months.
At month 0, immediately after randomization, the baseline assessment is completed in both intervention and control homes. Staff did not know the outcome of the randomisation when filling in the baseline measures (with the exception of the nursing home director).
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
- Single (Investigator)
盲法说明
During the data collection the investigators cannot be blinded, due to the nature of the intervention. However, during data analysis the researchers will be blinded for the unit of randomization of each nursing home, making use of encrypted data.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria for nursing homes:
- •the board of directors/the management express explicit motivation to participate in the study and agree to allocate at least a 0,10 FTE per week for at least two ACP Reference Person(s) per 30 to 40 nursing home beds, to carry out the tasks that are part of this project
- •have at least 100 beds
- •Inclusion criteria for care staff in the nursing homes:
- •able to speak and understand Dutch.
- •work in a participating nursing home as either (head) nurse, care assistant, psychologist, physiotherapist, occupational therapist, social worker, animator, or reference person dementia/palliative care
排除标准
- •Exclusion criteria for nursing homes:
- •nursing homes have taken/are taking part in another research study that is evaluating palliative care services or communication strategies, currently or in the past 4 years
- •they have - or are planning to develop during the foreseen duration of the trial - an extensive ACP policy, meaning that (i) all nursing home residents or their family (in principal) regularly receive ACP conversations (two conversations or more each year) or (ii) the nursing home is judged by the researchers as having explicit and detailed ACP guidelines available (corresponding to high-quality ACP procedures and practices)
- •major organisational changes or physical changes to the facility (e.g. building activities or staff re-organisation) are planned or ongoing during the study period.
研究组 & 干预措施
Intervention group
The ACP+ programme aims to improve or establish advance care planning (ACP) in the day-to-day routine of staff working in nursing homes.
The intervention implementation period has a total duration of 8 months and is divided into:
- a four-month preparation and training phase. During this phase the ACP reference persons will attend a "two-day training" given by the ACP trainers. Other staff will receive training by the reference persons on conducting ACP conversation or recognizing triggers for an ACP conversation in nursing home residents.
- A four-month follow-up phase in which ACP conversations are held with residents. Additional training sessions will be organized to give more in-depth knowledge to the ACP reference persons.
干预措施: ACP+ programme (Behavioral)
Control group
The staff of nursing homes in the control group will receive no additional training next to any standard education or continuous training. After the intervention and follow-up measures are finished, all nursing homes in the control group will be offered a shortened version of the ACP+ training programme as well as all ACP+ training materials.
结局指标
主要结局
Change in knowledge of and self-efficacy concerning ACP
时间窗: One questionnaire at baseline (T0), one questionnaire at follow-up (T1, 8 months after T0)
The knowledge questions concern legal rules and regulations in Belgium around ACP-related issues (for example, the legal status of an advanced directive). The self-efficacy questions survey the respondent's self-efficacy regarding ACP.
次要结局
未报告次要终点
研究者
Lieve Van den Block
Professor
End-of-Life Research Group