Timely Interventions to Enable and Reach Patients With Heart Failure, and Their Caregivers With Palliative Care
NCT ID: NCT06244953
Last Updated: 2025-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
240 participants
INTERVENTIONAL
2024-08-14
2027-10-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Regular screening with needs-guided palliative care treatments
The patient continues to receive clinical care from the cardiologist, as well as palliative care treatments that are based upon his/her reported distress and concerns.
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).
Usual Care
Patient is referred by cardiologist to palliative care.
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.
Interventions
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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).
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.
Eligibility Criteria
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Inclusion Criteria
1. 21 years or older and
2. able to communicate in English or Chinese 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.
* 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 or Chinese.
Exclusion Criteria
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.
* 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
21 Years
99 Years
ALL
No
Sponsors
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National Heart Centre Singapore
OTHER
Khoo Teck Puat Hospital
OTHER
National Cancer Centre, Singapore
OTHER
Responsible Party
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Principal Investigators
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Dr Shirlyn Neo, MBBS, MRCP (UK), MMed, FAMS
Role: PRINCIPAL_INVESTIGATOR
National Cancer Centre, Singapore
Locations
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National Heart Centre Singapore
Singapore, , Singapore
Sengkang General Hospital
Singapore, , Singapore
Khoo Teck Puat Hospital
Singapore, , Singapore
National Cancer Centre, Singapore
Singapore, , Singapore
Countries
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Central Contacts
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Facility Contacts
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References
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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: 10.1136/bmjopen-2025-100581.
Other Identifiers
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TIER-HF-PC
Identifier Type: -
Identifier Source: org_study_id
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