Timely Interventions to Enable and Reach Patients With Heart Failure, and Their Caregivers With Palliative Care

Overview

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

• Other TIER-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).
• Other Usual 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.

Primary outcome measures

• Patient quality of life (QOL) per the KCCQ-12 Questionnaire [Time frame: Every 8 weeks from baseline, till the point of patient death, or till week 48, whichever is earlier.]
• Patient quality of life (QOL) per the EUROQOL EQ-5D-5L Questionnaire [Time frame: Baseline, 8 weeks, 16 weeks, and 24 weeks.]
• Caregiver Quality of Life (QOL) [Time frame: Every 8 weeks from baseline, till the point of patient death, or till week 48, whichever is earlier.]

Secondary outcome measures (8)

• Acceptability of TIER-HF-PC from patient and caregiver participants - through completion of the client satisfaction questionnaire (CSQ-4) [Time frame: At Week 25.]
• Acceptability of TIER-HF-PC from patient and caregiver participants - through semi-structured interviews [Time frame: From Week 25 onwards, up to Week 48.]
• Patient anxiety and depression [Time frame: Baseline, 8 weeks, 16 weeks, and 24 weeks.]
• Patient and Caregiver Spirituality [Time frame: Baseline, 8 weeks, 16 weeks, and 24 weeks.]
• Patient and Caregiver Coping [Time frame: Baseline, 8 weeks, 16 weeks, and 24 weeks.]
• Assessment of impact of TIER-HF-PC on healthcare utilization [Time frame: Week 1 to Week 24.]
• Healthcare cost analysis [Time frame: Up to 24 weeks.]
• Survival analysis [Time frame: Up to 48 weeks.]

Eligibility criteria

Inclusion criteria

• Patients:

• 21 years or older and
• able to communicate in English/Chinese/Malay and
• be of stage C or D heart failure, as defined by American College of Cardiology/American Heart Association (ACC/AHA) classification system and
• have functional limitation of New York Heart Association (NYHA) functional status of at least 2 or more and
• be deemed by their cardiologist's clinical judgement to have an expected prognosis of at least 6 months survival, and
• have had a heart failure related hospitalization event (e.g. symptomatic decompensated heart failure) within 6 months prior to recruitment and
• 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:

• have cognitive impairment (e.g., dementia)
• have severe, untreated, active mental illness (e.g., major depressive disorder)
• have ventricular assist device implant.
• have non-reversible hearing or visual loss or
• are active drug abuser or
• already known to a palliative care service.
• Caregivers who meet any of the exclusion criteria at baseline will be ineligible for the study:

• have cognitive impairment (e.g., dementia) or
• have severe, untreated, active mental illness (e.g., major depressive disorder)
• have non-reversible hearing or visual loss.
• are active drug abuser or
• are a domestic helper for the patient

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

Singapore · 4 centers

• National Heart Centre Singapore — Singapore
• Sengkang General Hospital — Singapore
• Khoo Teck Puat Hospital — Singapore
• National Cancer Centre, Singapore — Singapore

Publications

• Neo SH, Yu K, Lee CF, Cheung YB. Interventions to enable and reach patients with heart failure and their caregivers, with palliative care (TIER-HF-PC): a study protocol of a two-armed parallel group, open label randomised controlled trial that evaluates the effectiveness of a tiered model of palliative care in tertiary cardiac institutes in Singapore. BMJ Open. 2025 Mar 27;15(3):e100581. doi: 10.1 PMID 40147986

Identifiers

NCT: NCT06244953 · TIER-HF-PC

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗