跳至主要内容
临床试验/NCT06314035
NCT06314035尚未招募不适用

"Effects of a Decision Support Intervention on End-of-life Care Planning in Chinese Older Adults With Advanced Disease and Their Family Members: A Feasibility Trial"

National Taipei University of Nursing and Health Sciences0 个研究点目标入组 60 人开始时间: 2024年3月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
Patients' decisional conflict regarding EOL care

研究概览

简要总结

This study aims to test the effects of a patient decision aid (PDA) on planning for end-of-life (EOL) care among older adults with COPD. The main questions it aims to answer are:

  1. Does a PDA improve the process of a person to make decisions on EOL care?
  2. Does a PDA improve the readiness of a person to join advance care planning (ACP) communication?
  3. Does a person make an advance directive after using a PDA?

Participants in this study will:

  1. Be randomly assigned to one of two groups.
  2. In the experimental group, participants will receive two 60-minute interactive consultations over four weeks, using a PDA to help clarify values and preferences for future medical care. A guidebook summarising these future care options will be provided.
  3. In the control group, participants will receive two 60-minute sessions on lifestyle modification and self-care management over four weeks using a guidebook with coaching. A guidebook summarising general health information will be provided.

Researchers will compare the intervention group to the control group to see if the PDA is better at improving the decision-making process on EOL care, the readiness of a person to join ACP communication and the chance to make an advance directive.

详细描述

I. Research Background:

Chronic Obstructive Pulmonary Disease (COPD) is a progressive life-limiting condition and one of the leading causes of death globally and locally(MacPherson et al., 2013). Patients with COPD experience increasing symptom burden as the disease progresses, resulting in repeated episodes of exacerbation and hospital admissions(Sapey & Stockley, 2006). However, they and their family members are generally unprepared for the health changes and the perceived "sudden" changes often lead to care incongruent with patients' preferences, compromised quality of life and mistrust towards the healthcare team. Despite the projected disease progression, interventions or mechanisms to discuss end-of-life (EOL) care have not been systematically introduced in the management of COPD (Momen et al., 2012).

Advance care planning (ACP) aims to support people to plan for EOL and communicate their care wishes with family and the healthcare team before they lose mental capacity (Rietjens et al., 2017). ACP is gaining increased attention from the public. However, studies have shown that patients and their family members were unprepared for ACP due to unrealistic expectations towards medical treatments and cultural taboos of discussing death-related issues(Chan et al., 2018; Cheng et al., 2019). Conventional ACP interventions have positive but limited effects on empowering patients or EOL care decision-making. Studies reporting the effects of ACP on patients' readiness, decisional conflict, and the concordance between care preferences and the EOL care provided are mixed (Bravo et al., 2016; Cohen et al., 2019; Michael et al., 2022).

Decision aids have been developed as tools to support patients in making informed and preference-sensitive treatment decisions, with some explicitly for ACP(Cardona-Morrell et al., 2017; Elwyn et al., 2006). A Cochrane review found that decision aids are effective in reducing decisional conflict, clarifying personal values, increasing decision-making behaviours and improving patient-doctor communication(Stacey et al., 2017). However, the effects of a locally-adapted disease-specific decision aid for COPD, on decision-making are lacking.

II. Research Objectives:

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
Single (Participant)

盲法说明

Participants will be blinded to their group assignment. The personnel administering the interventions will not be blinded

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 50 years (inclusive) or older.
  • Diagnosed with Chronic Obstructive Pulmonary Disease (COPD) by a physician.
  • Normal cognitive function.
  • Ability to communicate in Mandarin or Cantonese.
  • Willingness to participate in the study.

排除标准

  • This project will exclude individuals who only partially meet or do not meet the inclusion criteria. Only those who fully meet all inclusion criteria will be invited to participate in the study, and individuals from vulnerable groups or those lacking decision-making capacity will be excluded.

研究组 & 干预措施

Experimental Group

Experimental

Participants in experimental group will receive a COPD Decision Support Tool (PDA intervention).

干预措施: COPD Patient Decision Aid (Other)

Attention Control Placebo Group

Placebo Comparator

Participants in the attention control placebo group will receive a general health coaching intervention. Dose and time similar to experimental group.

干预措施: General Health Coaching Intervention (Other)

结局指标

主要结局

Patients' decisional conflict regarding EOL care

时间窗: Before intervention, after intervention and 3-month followup.

It will be measured using the SURE test to reflect the quality of the decision-making process. This test is derived from the Decisional Conflict Scale. It contains four items that measure uncertainty, inadequate knowledge, unclear values and inadequate support and resources. It is corresponding to the conceptual framework of this study. The response format will be dichotomous (0 = no, 1 = yes), with a higher score indicating a higher level of decisional conflict.

次要结局

  • Semi-structured Interviews(After intervention and 3-month followup.)
  • Patients' confidence level regarding three ACP actions - namely, appointing a surrogate and discussing EOL care with a surrogate and medical doctors.(Before intervention, after intervention and 3-month followup.)
  • Participants' understanding of the PDA(After intervention and 3-month followup.)
  • Patients' readiness for ACP(Before intervention, after intervention and 3-month followup.)
  • Participant's completion of an Advance Directive (AD)(Before intervention, 3-month followup)
  • Participant's subjective clarity of content, comfort during reading and viewing, and the usefulness of the information of the PDA.(After intervention and 3-month followup.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lai Ching Ting, Jenny

Assistant Professor

National Taipei University of Nursing and Health Sciences

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