Navigating Advanced Illness Goals And Treatment With Digital Engagement (NAVIGATE)

National University of Singapore200 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

200

Conditions

Paliative Care Advance Care Planning Digital Education Interventions

Interventions

CareverseBEHAVIORAL

Careverse 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 CareOTHER

Caregivers 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.

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

1\. Patient Participants Inclusion Criteria: 1. Singapore resident aged 21years and above, 2. patient able to identify one main caregiver in the care and medical decision-making for the patient; 3. patient able to communicate in either English, Chinese, Malay or Tamil; 4. 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 Exclusion Criteria: 1. Patients unable to identify a caregiver who is a medical decision-maker, 2. Patients are currently or was previously healthcare workers; or 3. Patients are diagnosed with dementia or deemed cognitively impaired as determined by the Abbreviated Mental Test. 3\. Caregiver Participants Inclusion Criteria: 1. caregivers are identified as a medical decision-maker for the patient 2. Singapore resident aged 21 years and above; and 3. able to communicate in English 4\. Caregiver Participants Exclusion Criteria: 1. caregivers are currently or were previously healthcare workers; 2. 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 3. caregivers diagnosed with dementia.

Outcomes

Primary Outcomes

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.

Time frame: Baseline, 1-week, and 6-week

Secondary Outcomes

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.

Time frame: Baseline, 6-week, and 6-month

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.

Time frame: Baseline, 6-week, and 6-month

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.