Clinical trial NCT06244953: Timely Interventions to Enable and Reach Patients With Heart Failure, and Their Caregivers With Palliative Care
Official title: Timely Interventions to Enable and Reach Patients With Heart Failure, and Their Caregivers With Palliative Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Keywords: Palliative care
Patients
Caregivers
Distress thermometer (DT)
Integrated Palliative Care Outcome Scale (IPOS)
TIER-HF-PC
Lead sponsor: National Cancer Centre, Singapore
Sponsor class: OTHER
Collaborators: name: National Heart Centre Singapore
name: Khoo Teck Puat Hospital
First posted: 2024-02-06
Enrollment: 240
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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 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.

Eligibility criteria: Inclusion Criteria:

* Patients:

  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.
* 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 or Chinese.

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 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

Primary outcomes:
measure: Patient quality of life (QOL)
timeFrame: Baseline, 8 weeks, 16 weeks, and 24 weeks.
Secondary outcomes:
measure: Acceptability of TIER-HF-PC from patient and caregiver participants - through completion of the client satisfaction questionnaire (CSQ-4)
timeFrame: Up to 48 weeks.
measure: Patient anxiety and depression
timeFrame: Baseline, 8 weeks, 16 weeks, and 24 weeks.
measure: Patient Spirituality
timeFrame: Baseline, 8 weeks, 16 weeks, and 24 weeks.
measure: Caregiver Quality of Life
timeFrame: Baseline, 8 weeks, 16 weeks, and 24 weeks.
measure: Assessment of impact of TIER-HF-PC on healthcare utilization
timeFrame: Up to 24 weeks.
measure: Healthcare cost analysis
timeFrame: Up to 24 weeks.
measure: Survival analysis
timeFrame: Up to 48 weeks.
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Heart Centre Singapore
city: Singapore
country: Singapore
facility: Sengkang General Hospital
city: Singapore
country: Singapore
facility: Khoo Teck Puat Hospital
city: Singapore
country: Singapore
facility: National Cancer Centre, Singapore
Study officials:
affiliation: National Cancer Centre, Singapore
name: Dr Shirlyn Neo, MBBS, MRCP (UK), MMed, FAMS
role: PRINCIPAL_INVESTIGATOR
References: