Dataset Information

ENABLE-SG (Educate, Nurture, Advise, Before Life Ends for Singapore) as a proactive palliative care model: protocol for a hybrid type 1 effectiveness-implementation randomized wait-list controlled trial.

ABSTRACT:

Background

Specialist palliative care is often provided late in the patient's disease trajectory in response to uncontrolled symptoms. Shifting from this reactionary illness-stress paradigm to a proactive health-wellness approach, the ENABLE (Educate, Nurture, Advise, Before Life Ends) telehealth model aims to enhance the coping, stress and symptom management, self-care, and advance care planning skills of patients with advanced cancers and their caregivers. The ENABLE model has been culturally adapted to Singapore (ENABLE-SG) and pilot-tested. A hybrid type 1 effectiveness-implementation design will be used to evaluate the effectiveness of ENABLE-SG while collecting real-world implementation data.

Methods

This single-centre, assessor-blind, wait-list (immediately vs. 6 months) randomized controlled trial will recruit 300 adult patients within 60 days of an advanced cancer diagnosis and their family caregivers from the National Cancer Centre of Singapore. ENABLE-SG comprises structured psychoeducational sessions with a telehealth coach, covering essential topics of early palliative care. Participants will be assessed at baseline and every 3 months until patient's death, 12 months (caregivers), or end of study (patients). The primary outcome is patient quality of life 6 months after baseline. Secondary patient-reported outcomes include mood, coping, palliative care concerns, and health status. Secondary caregiver-reported outcomes include caregiver quality of life, mood, coping, and care satisfaction. Mixed-effects regression modelling for repeated measurements will be used. To assess the effectiveness of ENABLE-SG versus usual care, patient and caregiver outcomes at 6 months will be compared. To compare earlier versus delayed ENABLE-SG, patient and caregiver outcomes at 12 months will be compared. Within the hybrid type 1 effectiveness-implementation design, implementation outcomes will be evaluated in both the early and delayed groups. Acceptability, adoption, appropriateness, and feasibility will be assessed using a feedback survey and semi-structured interviews with a purposive sample of patients, caregivers, and healthcare providers. Transcribed interviews will be analysed thematically. Other implementation outcomes of penetration, fidelity, and cost will be assessed using records of study-related processes and summarized using descriptive statistics. A cost-effectiveness analysis will also be conducted.

Discussion

This study will assess both effectiveness and implementation of ENABLE-SG. Insights into implementation processes can facilitate model expansion and upscaling.

Trial registration

Registered prospectively on ClinicalTrials.gov, NCT06044441. Registered on 21/09/2023.

SUBMITTER: Ke Y

PROVIDER: S-EPMC10826230 | biostudies-literature | 2024 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

ENABLE-SG (Educate, Nurture, Advise, Before Life Ends for Singapore) as a proactive palliative care model: protocol for a hybrid type 1 effectiveness-implementation randomized wait-list controlled trial.

Ke Yu Y Cheung Yin Bun YB Bakitas Marie M Odom J Nicholas JN Lum Elaine E Tan Daniel Shao Weng DSW Tan Tira J TJ Finkelstein Eric E Oh Hong Choon HC Zhou Siqin S Yang Grace Meijuan GM

BMC palliative care 20240130 1

<h4>Background</h4>Specialist palliative care is often provided late in the patient's disease trajectory in response to uncontrolled symptoms. Shifting from this reactionary illness-stress paradigm to a proactive health-wellness approach, the ENABLE (Educate, Nurture, Advise, Before Life Ends) telehealth model aims to enhance the coping, stress and symptom management, self-care, and advance care planning skills of patients with advanced cancers and their caregivers. The ENABLE model has been cul ...[more]

PMID: 38287335

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Project description:BackgroundPalliative care is specialized medical care for people with serious illness that is focused on providing relief from symptoms and stress and improving the quality of life (QOL) for patients and their families. To help the 6.5 million U.S. adults and families affected by heart failure manage the high symptom burden, complex decision-making, and risk of exacerbation and death, the early integration of palliative care is critical and has been recommended by numerous professional organizations. However, few trials have tested early outpatient community-based models of palliative care for patients diagnosed with advanced heart failure and their caregivers. To address this gap, through a series of formative evaluation trials, we translated an oncology early palliative care telehealth intervention for heart failure to create ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends, Comprehensive Heartcare for Patients and Caregivers).Methods/designThe primary objective of this multisite pragmatic randomized controlled trial is to test the efficacy of ENABLE CHF-PC plus usual heart failure care compared to usual care alone. Community-dwelling persons who are ≥50 years of age with New York Heart Association class III/IV or American Heart Association/American College of Cardiology stage C/D heart failure and their primary caregiver (if present) are being randomized to one of two study arms. The ENABLE CHF-PC intervention group receives usual heart failure care plus an in-person palliative care assessment by a board-certified palliative care provider (caregivers are invited to attend), a series of nurse coach-led, weekly psychoeducational 20 to 60 min phone sessions using a guidebook called Charting Your Course (patients: 6 sessions and caregivers: 4 sessions), and monthly check-in calls. Charting Your Course topical content includes problem-solving, coping, self-care and symptom management, communication, decision-making, advance care planning, and life review (patients only). Primary outcomes include patient QOL and mood (depressive symptoms/anxiety) and caregiver QOL, mood, and burden at 8 and 16 weeks after baseline. Outcomes will be examined using an intention-to-treat approach and mixed effects modeling for repeated measures.DiscussionThis trial will determine whether the ENABLE CHF-PC model of concurrent heart failure palliative care is superior to usual heart failure care alone in achieving higher patient and caregiver QOL, improving mood, and lowering burden.Trial registrationClinicalTrials.gov, NCT02505425 . Registered on 22 July 2015.

Project description:The Singapore Longitudinal Early Development Study (SG-LEADS) seeks to understand factors that can enhance or hinder Singaporean children's early childhood development with an aim to inform public policies that can help each child reach his or her potential. SG-LEADS is a nationally representative household survey that focuses on Singaporean households with children aged 0-6 at the baseline. It adopts a multi-stage probability sampling - clustered and stratified sampling strategy - with an oversample of the low-income households residing in 1-3-room HDB (Housing Development Board) public housing units. In-home face-to-face interviews were conducted on the computer-assisted personal interviewing (CAPI) systems. The baseline survey was conducted between 2018 and 2019. Up to two eligible children and their primary caregivers were interviewed in each household. In total, 5,005 Singaporean children aged 0-6 in 3,476 households and their primary caregivers were successfully interviewed. In 2021, 4,351 children in 3,017 households were successfully re-interviewed. The contents of SG-LEADS are designed based on theories in multiple disciplines including sociology, psychology and economics about how multiple contexts (home, out-of-home care institution, community and state) interact to shape the multiple domains of child development. The survey includes assessments of children's motor, social-emotional well-being, language and cognitive skills, and biometric measures. Rich data about the family's socioeconomic, demographic and cultural backgrounds, family structure, family relations, home environment, social support, food security, financial distress, public program participation, and neighborhood characteristics and cohesion were collected. Comprehensive information was obtained about the target child's early childcare and preschool arrangements, children's time use (through time diaries), technology use, enhancement activities, nutrition intake and more. Primary caregivers' social-emotional well-being, cognitive skills, and parenting behavior were also assessed. In Wave 2, a special module about the family's COVID-19 experiences and responses was added. Descriptive statistics were presented on the study website. Multivariate analyses were conducted based on the SG-LEADS dataset with a variety of robust methodologies such as structural equation modeling, fixed effect analysis, lagged dependent variable model, hierarchical regression analyses, mediation analysis, propensity score matching, and so forth. Thus far, 14 journal articles have been published with a dozen or so papers under review. These analyses cover a wide range of topics, including but not limited to, 1) the impact of socioeconomic status on children's development such as infants' vocabulary, children's academic achievement and socio-emotional development, 2) the impact of paternity leave-taking on child outcome (3) how food insecurity affects children's behavior, (4) family experiences and resilience during COVID-19, (6) childcare arrangements and children's behavior and cognitive development, (6) children's ability to delay gratification in early childhood, (7) children in cross-national families, 8) children's time use, (9) family and community social capital and child development. The rich data in this longitudinal study provide many opportunities to research a wide range of topics related to early child development in an Asian context. This dataset holds tremendous potential to uncover valuable insights and inform evidence-based policy interventions to support optimal early childhood development. International comparative studies can also be conducted with similar surveys conducted in other countries.

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Dataset Information

ENABLE-SG (Educate, Nurture, Advise, Before Life Ends for Singapore) as a proactive palliative care model: protocol for a hybrid type 1 effectiveness-implementation randomized wait-list controlled trial.

Background

Methods

Discussion

Trial registration

Publications

ENABLE-SG (Educate, Nurture, Advise, Before Life Ends for Singapore) as a proactive palliative care model: protocol for a hybrid type 1 effectiveness-implementation randomized wait-list controlled trial.

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