NCT06244953

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: National Cancer Centre, Singapore · Academic / Other
• Sex: All
• Age: 21 Years – 99 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-08-14
• Primary completion: 2026-10-31
• Completion: 2027-10-31
• First posted: 2024-02-06
• Last updated: 2025-04-08

Locations

4 sites across 1 country: Singapore