Navigating Advanced Illness Goals And Treatment With Digital Engagement (NAVIGATE): A Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Advance Care Planning Engagement Survey for Surrogate Decision-Maker
研究概览
简要总结
The goal of this two-armed, parallel-design, pre-/post-intervention assessment clinical trial is to learn if a digital and interactive website helps to improve advance care planning (ACP) engagement among caregivers of patients with serious illness. The main questions it aims to answer are:
Does the website increase ACP engagement of caregivers of patients with serious illness? Researchers will compare the digital and interactive website to the usual care (a digital booklet) to see if the digital intervention works to improve ACP engagement among caregivers.
Participants who are caregivers will:
- Be introduced to a digital website and asked to explore the site over the course of the study.
- Complete four self-administered questionnaires (baseline, one-week, six-week, and six-month).
Participants who are patients will not have any intervention assigned and will only have their observational data collected through four interviewer-administered questionnaires (baseline, one-week, six-week, and six-month)
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 (Participant)
盲法说明
Treatment allocation will be masked from participants for the entirety of the study. We do not anticipate unblinding of participants to treatment status. Effort to maintain blinding of participants include training our research coordinators (RCs) to strictly follow a protocol and script in all interactions with participants. RCs are blinded of treatment allocation during recruitment, consent-taking and baseline survey process, minimising the risk of selection bias. Once participants are randomised into their allocated arm, RCs will be aware of the participant's treatment allocation as RCs will need to ensure that participants successfully complete the signup process required for the intervention arm. Risks of unmasking caregivers participants is minimal as followup questionnaires are completed via self-administered online survey without the RCs being present.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Patient Participants Inclusion Criteria:
- •Singapore resident aged 21years and above,
- •patient able to identify one main caregiver in the care and medical decision-making for the patient;
- •patient able to communicate in either English, Chinese, Malay or Tamil;
- •patient meeting one of the following illness criteria: 4a. Patients with brain tumours: histological and/or radiological diagnosis of glioma or brain metastases.
- •4b. Patients with spontaneous intracerebral haemorrhage (SICH) based on radiological diagnosis of SICH on baseline computed-tomographic scans.
- •4c. Patients with CKD Stage 4 and 5, identified at G4 or G5 of CKD, glomerular filtration rate (GFR) 30 ml/min or less, inclusive of kidney failure on kidney replacement therapy; and (5) Physicians assessment that ACP is appropriate for the patient by physicians.* (*) The attending clinicians may base the assessment of ACP appropriateness on several factors in addition to high mortality risk. As a baseline, clinicians are asked to base their assessment of high mortality risk using the validated "Surprise" question.
- •2. Patient participants
排除标准
- •Patients unable to identify a caregiver who is a medical decision-maker,
- •Patients are currently or was previously healthcare workers; or
- •Patients are diagnosed with dementia or deemed cognitively impaired as determined by the Abbreviated Mental Test.
- •3. Caregiver Participants Inclusion Criteria:
- •caregivers are identified as a medical decision-maker for the patient
- •Singapore resident aged 21 years and above; and
- •able to communicate in English
- •4. Caregiver Participants Exclusion Criteria:
- •caregivers are currently or were previously healthcare workers;
- •caregivers not involved in primary care of the patient (including providing care to the patient, supervision of care, or involved in making decisions regarding treatment the patient receives); or
- •caregivers diagnosed with dementia.
研究组 & 干预措施
Comparator arm
For caregiver participants: Usual care. For patient participants: usual care, as prescribed by the clinical care team, is unaffected by the study design and we only conduct observational measurements of patient participants during the course of the study.
干预措施: Usual Care (Other)
Intervention arm
For caregiver participants: Enrolled caregiver participants randomised in the intervention arm will be directed to the intervention digital website and guided through the signup process. Once logged in, they are asked to explore and use the website contents and tools in their own time.
For patient participants: usual care, as prescribed by the clinical care team, is unaffected by the study design and we only conduct observational measurements of patient participants during the course of the study.
干预措施: Careverse (Behavioral)
结局指标
主要结局
Advance Care Planning Engagement Survey for Surrogate Decision-Maker
时间窗: Baseline, 1-week, and 6-week
The 17-item ACP Surrogate Decision Making Instrument (ACP-17 SDM) developed by Sudore et. al., is a validated questionnaire designed to assess how engaged surrogate decision makers (SDMs) are in the advance care planning process. The ACP-17 SDM measures engagement across three domains: 1) Serving as SDM (7 items), 2) Contemplation (4 items), and 3) Readiness (6 items). Each item is answered on a 5-point Likert scale (1 = not at all/never, to 5 = extremely/A lot), and higher mean scores (range: 1.0 - 5.0) indicate higher engagement in ACP by the surrogate. Van Scoy, Lauren J., et al. "Adaptation and preliminary validation of the advance care planning engagement survey for surrogate decision makers." Journal of pain and symptom management 57.5 (2019): 980-988.
Advance Care Planning Engagement Survey for Surrogate Decision-Maker
时间窗: Baseline, 1-week, and 6-week
The 17-item ACP Surrogate Decision Making Instrument (ACP-17 SDM) developed by Sudore et. al., is a validated questionnaire designed to assess how engaged surrogate decision makers (SDMs) are in the advance care planning process. The ACP-17 SDM measures engagement across three domains: 1) Serving as SDM (7 items), 2) Contemplation (4 items), and 3) Readiness (6 items). Each item is answered on a 5-point Likert scale (1 = not at all/never, to 5 = extremely/A lot), and higher mean scores (range: 1.0 - 5.0) indicate higher engagement in ACP by the surrogate. Van Scoy, Lauren J., et al. "Adaptation and preliminary validation of the advance care planning engagement survey for surrogate decision makers." Journal of pain and symptom management 57.5 (2019): 980-988.
次要结局
- Satisfaction with care(Baseline, 6-week, and 6-month)
- Satisfaction with care - Feeling Heard and Understood(Baseline, 6-week, and 6-month)
- Goals of care(Baseline, 1-week, 6-week, and 6-month)
- Caregivers Wellbeing(Baseline, 1-week, 6-week, and 6-month)
- Caregiver quality of life - Mental health(Baseline, 1-week, 6-week, and 6-month)
- Caregiver dyadic relationship(Baseline, 1-week, 6-week, and 6-month)
- Patient Healthcare Utilisation(Within six months pre-and post-intervention OR 12 months before death)
- Patient quality of life(Baseline, 1-week, 6-week, and 6-month)
- Satisfaction with care(Baseline, 6-week, and 6-month)
- Satisfaction with care - Feeling Heard and Understood(Baseline, 6-week, and 6-month)
- Goals of care(Baseline, 1-week, 6-week, and 6-month)
- Caregivers Wellbeing(Baseline, 1-week, 6-week, and 6-month)
- Caregiver quality of life - Mental health(Baseline, 1-week, 6-week, and 6-month)
- Caregiver dyadic relationship(Baseline, 1-week, 6-week, and 6-month)
- Patient Healthcare Utilisation(Within six months pre-and post-intervention OR 12 months before death)
- Patient quality of life(Baseline, 1-week, 6-week, and 6-month)
研究者
Gerald Koh
Professor
National University of Singapore