Heart Failure
Conditions
Keywords
Palliative care, Patients, Caregivers, Distress thermometer (DT), Integrated Palliative Care Outcome Scale (IPOS), TIER-HF-PC
Brief summary
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.
Detailed description
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 health coach, with support by a palliative care physician. This health coach 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 health coach 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.
Interventions
OTHERTIER-HF-PC
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).
OTHERUsual Care
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.
Sponsors
National Cancer Centre, Singapore
National Heart Centre Singapore
Khoo Teck Puat Hospital
Sengkang General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Patients: 1. 21 years or older and 2. able to communicate in English/Chinese/Malay and 3. be of stage C or D heart failure, as defined by American College of Cardiology/American Heart Association (ACC/AHA) classification system and 4. have functional limitation of New York Heart Association (NYHA) functional status of at least 2 or more and 5. be deemed by their cardiologist's clinical judgement to have an expected prognosis of at least 6 months survival, and 6. have had a heart failure related hospitalization event (e.g. symptomatic decompensated heart failure) within 6 months prior to recruitment and 7. have a phone that allows telecommunication. * Caregivers must meet all the following inclusion criteria to be eligible for the study : * direct, unpaid, family caregiver of the patient; * self-reported by the patient to be the main person to be either: * responsible for up to 4 hours a day of caregiving tasks * and/or decision maker/spokesperson with the medical team * Caregiver may or may not live in the same residence as the patient. * Caregivers must be 21 years and above. * Able to communicate in English/Chinese/Malay.
Exclusion criteria
* Patients: 1. have cognitive impairment (e.g., dementia) 2. have severe, untreated, active mental illness (e.g., major depressive disorder) 3. have ventricular assist device implant. 4. have non-reversible hearing or visual loss or 5. are active drug abuser or 6. already known to a palliative care service. * Caregivers who meet any of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient quality of life (QOL) per the KCCQ-12 Questionnaire | Every 8 weeks from baseline, till the point of patient death, or till week 48, whichever is earlier. | The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) will be used: It is a 12-item QOL scale, composed of physical function, symptoms, QOL, social interference and summary score will be used. The KCCQ-12 has similar validity to the 23-item version and is shorter with less respondent burden. The KCCQ-12 can be self-reported by patients or read to patients over the phone by a research coordinator. The total summary score can range from 0 to 100, with higher scores representing better health status. A clinically meaningful change is defined as a change of at least 5 points on the KCCQ. The KCCQ-12 will be measured for all participants (TIER-HF-PC and usual care), and tracked every 8 weeks from baseline, till the point of patient death, or till week 48, whichever is earlier. The frequency of our proposed KCCQ tracking is referenced from trials which used KCCQ to track longitudinal changes in QOL. |
| Patient quality of life (QOL) per the EUROQOL EQ-5D-5L Questionnaire | Baseline, 8 weeks, 16 weeks, and 24 weeks. | The non cardiac specific health-related quality of life (EUROQOL EQ-5D-5L) questionnaire will also be used: This is a global assessment of the patient's quality-of-life in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, that can also be administered over the phone. The results from the 5 dimensions can be combined into a 5-digit number that describes the patient's health state utility. The EQ-5D-5L has been validated in the Singapore cardiac population. |
| Caregiver Quality of Life (QOL) | Every 8 weeks from baseline, till the point of patient death, or till week 48, whichever is earlier. | The Singapore Caregiver Quality of Life Scale-15 (SCQOLS-15) will be used: This is a 15-item scale with 5 domains measuring QOL of life caregivers in domains: physical well-being, mental well-being, experience and meaning, impact on daily life, and financial well-being will be used. This will be measured for all caregiver participants (TIER-HF-PC and usual care), and tracked every 8 weeks from baseline, till the point of patient death, or till week 48, whichever is earlier. A difference of between 3-5 points in QOL scores could serve as a benchmark to evaluate if the difference between intervention and usual-care group is meaningful. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of TIER-HF-PC from patient and caregiver participants - through completion of the client satisfaction questionnaire (CSQ-4) | At Week 25. | The client satisfaction questionnaire (CSQ-4) will be used. The total score of the CSQ per participant will be computed. Analysis will be conducted on the patient and caregiver scores separately. The percentage of participants in TIER-HF-PC who have at least a CSQ score of 12 and above will also be calculated. |
| Acceptability of TIER-HF-PC from patient and caregiver participants - through semi-structured interviews | From Week 25 onwards, up to Week 48. | Regarding the analysis of semi-structured interviews, a qualitative coding team who is experienced in qualitative analysis will be formed. Interviews will be open coded line by line. Code categories will be developed and iteratively adjusted through discussions. The code categories will be subsequently mapped back to the main domains of the RE-AIM and PRISM framework to identify key multi-level contextual factors influencing the TIER-HF-PC outcomes as well as to assess the adoption, implementation, and impact of TIER-HF-PC. Hence, the analysis will involve both inductive and deductive approaches. |
| Patient anxiety and depression | Baseline, 8 weeks, 16 weeks, and 24 weeks. | The Hospital Anxiety and Depression Scale (HADS) will be used. This is a 14-item scale with a score range of 0 to 42. It is composed of two subscales- anxiety and depression- with a cut-off point of 11 for each subscale, that determines anxiety and depression of clinical significance. |
| Patient and Caregiver Spirituality | Baseline, 8 weeks, 16 weeks, and 24 weeks. | The Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12 Item Scale (Facit-SP-12)/Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Non-Illness (FACIT-Sp Non-Illness) will be used. This is a 12-item survey that measures the spiritual well-being of patients and caregivers. The total of Facit-SP-12/ FACIT-Sp Non-Illness ranges from 0 to 48 with higher scores representing increased spirituality. |
| Patient and Caregiver Coping | Baseline, 8 weeks, 16 weeks, and 24 weeks. | Brief Coping with Problems Experienced (Brief-COPE) scale will be used. It is a 28-item scale measuring the ways people cope with stressful events. It has been used in the heart failure population, where the coping style was shown to correlate with the level of physical functioning. |
| Assessment of impact of TIER-HF-PC on healthcare utilization | Week 1 to Week 24. | The differences in community hospice usage, number and length of hospital admissions, number of emergency visits, number, and length of intensive care visits between TIER-HF-PC participants and those in usual care will be assessed using generalized linear models, with binomial model for community hospice usage and Poisson model with robust standard effort for other healthcare utilization outcomes. |
| Healthcare cost analysis | Up to 24 weeks. | 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 and the cost differences between both groups will be quantified by generalized linear model with Gamma model and robust standard error. The net cost of the TIER-HF-PC model will be calculated based upon the cost of care provision in TIER-HF-PC minus the cost savings from reduction of health care utilization. We will also calculate incremental cost-effectiveness ratios (ICERs) to measure the average net cost per quality-adjusted-life-year (QALY) gained for TIER-HF-PC versus usual care participants. The QALY will be calculated by the product of quality-of-life (EQ-5d-5L) and survival. |
| Survival analysis | Up to 48 weeks. | 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. |
Countries
Singapore
Contacts
CONTACTDr Shirlyn Neo, MBBS, MRCP (UK), MMed, FAMS
PRINCIPAL_INVESTIGATORDr Shirlyn Neo, MBBS, MRCP (UK), MMed, FAMS
National Cancer Centre, Singapore
Outcome results
None listed