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)
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.
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.
caregivers are identified as a medical decision-maker for the patient
Parallel
Careverse
BehavioralCareverse is a digital psychoeducational website designed to assist caregivers and patients to clarify their values, end-of-life preferences, enable surrogates to further their understanding of the patient's wishes, and prepare surrogates for the role and responsibilities of a medical decision maker. The intervention consists of values elicitation tools, educational materials, and testimonies. The participants will receive guides on how to initiate/re-introduce discussions about end-of-life wishes with their loved ones and clinicians.
Usual Care
Other interventionCaregivers in the comparator arm will receive a digital version of standard advanced care planning education material prepared by Agency of Integrated Care. The ACP Workbook is created by AIC to help individuals explore their values, care preferences, and end-of-life goals in a structured, reflective way.
Advance Care Planning Engagement Survey for Surrogate Decision-Maker
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.
Satisfaction with care
We measure patients and caregivers' satisfaction with care that they (or their patient) received using the Short Assessment of Patient Satisfaction (SAPS), a brief, validated, and generic 7-item questionnaire designed to efficiently measure patient satisfaction across a range of health care settings.\[49-51\] Each question is rated on a 5-point Likert scale (ranging from 0 to 4), and the items cover key domains of patient satisfaction including:1) Satisfaction with treatment, 2) Explanation of treatment results, 3) Clinician care and thoroughness, 4) Involvement in decision-making, 5) Respect received from the clinician, 6) Adequacy of time with the clinician, and 7) Overall satisfaction with care received. Total scores range from 0 to 28, and higher scores indicate greater satisfaction.
Satisfaction with care - Feeling Heard and Understood
We measure how well patients and caregivers feel heard and understood by those caring for them in the hospital environment using the following point-of-care item: "Over the past 1(6) months, how much have you felt heard and understood by the doctors, nurses and hospital staff?". Response is rated on a 5-point scale (completely, quite a bit, moderately, slightly, not at all). Responses are reverse-coded, ranging from 1 - 5, with higher score indicates better quality of care. Gramling, R., et al., Feeling Heard and Understood: A Patient-Reported Quality Measure for the Inpatient Palliative Care Setting. Journal of Pain and Symptom Management, 2016. 51(2): p. 150-154.
Goals of care
We assess participants' preferences for aggressive care using goals of care questions adapted from the CanCORS Study. Participants were asked to trade-off between life-extension treatments or 1) those that miminise pain/discomfort and 2) those that were less costly. Participants responded on a scale of 1 to 9, where 1 represented maximal life extension with severe pain or discomfort (or with higher costs), 5 represented moderate life extension and moderate pain or discomfort (or moderate cost), and 9 indicated no life extension but minimal pain or discomfort (or lower costs). Scores 1 to 4 were categorized as prioritizing life extension, and scores 6 to 9 were categorized as prioritizing symptom management or cost containment. Malin, J.L., et al., Understanding cancer patients' experience and outcomes: development and pilot study of the Cancer Care Outcomes Research and Surveillance patient survey. Support Care Cancer, 2006. 14(8): p. 837-48.
Caregivers Wellbeing
We assess caregiver's quality of life using the Singapore Caregivers Quality of Life Scale (SCQOLS), a validated instrument developed specifically to assess the quality of life (QoL) of family caregivers of patients with advanced illnesses in Singapore. The 10-item SCQOLs measures five domains of quality of life of family caregivers of patients: (1) Physical Well-being (2 items); (2) Mental Well-being (2 items); (3) Experience \& Meaning (2 items); (4) Impact on Daily Life (2 items) (5) Financial Well-being (2 items). Each item is rated on a 5-point scale, ranging from 0 (Not at All) to 4 (Very Much). Item scores are rescaled and summed. Total scores range from 0 - 100, with higher scores indicating better quality of life. Cheung, Yin Bun, et al. "Two valid and reliable short forms of the Singapore caregiver quality of life scale were developed: SCQOLS-10 and SCQOLS-15." Journal of Clinical Epidemiology 121 (2020): 101-108.
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National University of Singapore
Lead sponsor
National University Hospital, Singapore
Collaborator
