There is evidence for the effectiveness and feasibility of the individual components of TIER-HF-PC, however there is a need to test how these individual components interact to allow the researchers to deliver TIER-HF-PC as a model of care in its totality. In the short term, this study will assess if TIER-HF-PC is beneficial for patients and caregivers.
Timely Interventions to Enable and Reach patients with Heart Failure, and their caregivers with Palliative Care, or TIER-HF-PC, is a novel model of palliative care, designed to address gaps of palliative care delivery for patients with advanced heart failure, and their caregivers. TIER-HF-PC is a service, led by a palliative care nurse, with support by a palliative care physician. This nurse will actively screen and monitor patients for problems, and then match the type and intensity of palliative care treatments to the severity of problems reported. The nurse will also facilitate processes for patients to initiate contact with health care providers should problems arise. This decreases the overall burden on palliative care services, enabling a scalable and more cost-effective model of care for a larger number of patients. The service will also utilize a proactive approach to care, increasing self-care skills and understanding of disease and treatment options. Earlier palliative care support will enable problems to be managed actively before they escalate into crises. Overall aim: To test the effectiveness and implementation of the interacting components of TIER-HF-PC. Specific aim 1a: To evaluate the impact of TIER-HF-PC on patients. The primary outcome is patient quality-of-life at 24 weeks, measured on the Kansas City Cardiomyopathy Questionnaire. Secondary outcomes include patient anxiety, depression, coping, spirituality, healthcare utilization, survival, and cost-effectiveness of TIER-HF-PC. Specific aim 1b: To evaluate the impact of TIER-HF-PC on caregivers. Outcomes evaluated include caregiver quality-of-life. \- Hypothesis 1: The researchers hypothesize that TIER-HF-PC will be superior to usual care, in improving patient and caregiver quality-of-life. Specific aim 2: To evaluate the implementation outcomes of TIER-HF-PC. \- Hypothesis 2: The researchers hypothesize that participants will be satisfied with the TIER-HF-PC service, though modifications might be needed for fine-tuning of the appropriateness and timeliness of care provision in TIER-HF-PC. They will evaluate these implementation outcomes through a validated service evaluation survey and semi-structured interviews. Fidelity to study protocols will be assessed through audits of case notes and study processes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
240
The patient will be assigned to one of the three levels of care which is determined by the results given by Distress Thermometer (DT) and the Integrated Palliative Care Outcome Scale (IPOS).
Patient continues on clinical care by his/her cardiologist. If the cardiologist picks up their symptoms or other concerns, he/or can be referred to a specialist palliative care physician by the cardiologist.
National Heart Centre Singapore
Singapore, Singapore
RECRUITINGSengkang General Hospital
Singapore, Singapore
RECRUITINGKhoo Teck Puat Hospital
Singapore, Singapore
RECRUITINGPatient quality of life (QOL)
Patient quality of life will be measured at baseline, and again at 8 weeks, 16 weeks, and 24 weeks using KCCQ-12. Descriptive statistics, and measures of effect size will be used to compare the study groups at baseline, 8 weeks, 16 weeks, and 24 weeks. Longitudinal data analyses will be conducted to examine intervention effects using linear mixed-effects-modelling for repeated measures at baseline, 8 through 16 and 24 weeks, constraining the baseline mean to be equal between intervention and control groups with indicators for time, group, and time by group interactions. Estimate of standard deviation of residuals from the mixed-effects model will be used to compute effect size (Cohen's d) to estimate the efficacy. The minimum score on KCCQ is 0 and maximum possible score is 100. A higher score indicates a better quality of life.
Time frame: Baseline, 8 weeks, 16 weeks, and 24 weeks.
Acceptability of TIER-HF-PC from patient and caregiver participants - through completion of the client satisfaction questionnaire (CSQ-4)
The total score of the CSQ-4 will be calculated for each participant. For the assessment of acceptability, scores from participants from both intervention and control groups will be pooled. The minimum expected score per participant is 4, and the maximum expected score per participant is 16. A higher score indicates higher satisfaction. The percentage of participants in TIER-HF-PC who have at least a CSQ score of 12 and above will also be calculated.
Time frame: Up to 48 weeks.
Patient anxiety and depression
Patient anxiety will be tracked at baseline, 8 weeks, 16 weeks, and 24 weeks, using the hospital anxiety and depression scale (HADS). Descriptive statistics and measures of effect size will be used to compare the study groups at baseline, 8 weeks, 16 weeks and 24 weeks. Longitudinal data analyses will be conducted to examine intervention effects using linear mixed-effects-modelling for repeated measures at baseline, 8 through 16 and 24 weeks, constraining the baseline mean to be equal between intervention and control groups with indicators for time, group, and time by group interactions. Estimate of standard deviation of residuals from the mixed-effects model will be used to compute effect size (Cohen's d) to estimate the efficacy.
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National Cancer Centre, Singapore
Singapore, Singapore
RECRUITINGTime frame: Baseline, 8 weeks, 16 weeks, and 24 weeks.
Patient Spirituality
Patient spirituality will be tracked at baseline, 8 weeks, 16 weeks and 24 weeks, using the Functional Assessment of Chronic Illness Therapy Spiritual Well-Being Scale (FACIT-Sp-12). Descriptive statistics and measures of effect size will be used to compare the study groups at baseline, 8 weeks, 16 weeks and 24 weeks. Longitudinal data analyses will be conducted to examine intervention effects using linear mixed-effects-modelling for repeated measures at baseline, 8 through 16 and 24 weeks, constraining the baseline mean to be equal between intervention and control groups with indicators for time, group, and time by group interactions. Estimate of standard deviation of residuals from the mixed-effects model will be used to compute effect size (Cohen's d) to estimate the efficacy.
Time frame: Baseline, 8 weeks, 16 weeks, and 24 weeks.
Caregiver Quality of Life
The change in caregiver quality of life (QOL) at 8 weeks, 16 weeks, and 24 weeks as compared to baseline will be evaluated. The outcome measure used is the Singapore Caregiver Quality of Life Scale (SCQOLS-15). Descriptive statistics and measures of effect size will be used to compare the study groups at baseline, 8 weeks, 16 weeks and 24 weeks. Longitudinal data analyses will be conducted to examine intervention effects using linear mixed-effects-modelling for repeated measures at baseline, 8 through 16 and 24 weeks, constraining the baseline mean to be equal between intervention and control groups with indicators for time, group, and time by group interactions. Estimate of standard deviation of residuals from the mixed-effects model will be used to compute effect size (Cohen's d) to estimate the efficacy.
Time frame: Baseline, 8 weeks, 16 weeks, and 24 weeks.
Assessment of impact of TIER-HF-PC on healthcare utilization
1. The difference in the number of community hospice referrals, number of emergency visits, number of intensive care visits between TIER-HF-PC participants and those in usual care will be summarized using descriptive statistics. 2. The difference in average length of hospital admissions and average length of intensive care unit visits between TIER-HF\_PC participants and those in usual care will also be summarized using descriptive statistics.
Time frame: Up to 24 weeks.
Healthcare cost analysis
The total cost of inpatient bills and outpatient bills including emergency visit bills for TIER-HF-PC participants and usual care participants from week 1 to week 24 will be summed up to quantify the cost differences between both groups by generalized linear model with Gamma model and robust standard error.
Time frame: Up to 24 weeks.
Survival analysis
The differences in survival between TIER-HF-PC and usual care will be analyzed using a Cox model regression, censoring at week 48 or death, whichever occurs earlier.
Time frame: Up to 48 weeks.