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Published on: February 13, 2021
Palliative care needs in patients hospitalized with heart failure (PCHF) study: rationale and design
Ross T Campbell1, Colette E Jackson2, Ann Wright1
1BHF Glasgow Cardiovascular Research Centre University of Glasgow Glasgow Scotland UK.
Insights
This study identifies patient needs for palliative care (PC) in heart failure (HF) to design a future clinical trial. Findings will guide the development of effective PC interventions for HF patients.
Area of Science:
- Cardiology
- Palliative Care
- Clinical Trial Design
Background:
- Heart failure (HF) patients often have significant unmet palliative care (PC) needs.
- Designing effective PC interventions for HF requires understanding patient populations and specific needs.
- Existing research lacks comprehensive data to inform a targeted PC intervention trial in HF.
Purpose of the Study:
- To gather data for designing a randomized controlled trial (RCT) of a PC intervention in HF.
- To identify a suitable HF patient population with high, quantifiable PC needs.
- To define essential components of a PC intervention and relevant trial outcomes for HF.
Main Methods:
- Prospective cohort study of hospitalized acute decompensated HF patients over 2 years.
- Screening using B-type natriuretic peptide and echocardiography; comprehensive characterization of HF status, comorbidities, and PC needs.
- Quantitative assessment of quality of life, mood, symptoms, caregiver burden, and end-of-life care; long-term follow-up for outcomes including mortality.
Main Results:
- Prevalence and trajectory of PC needs in HF patients will be determined.
- Methods for identifying HF patients with PC needs will be evaluated.
- Healthcare utilization patterns associated with PC needs in HF will be estimated.
Conclusions:
- The study will establish a foundation for an RCT of PC interventions in HF.
- Data will inform the selection of appropriate patient populations and outcome measures.
- This research will guide the development of targeted PC interventions to improve HF patient care.
Aims:
The primary aim of this study is to provide data to inform the design of a randomized controlled clinical trial (RCT) of a palliative care (PC) intervention in heart failure (HF). We will identify an appropriate study population with a high prevalence of PC needs defined using quantifiable measures. We will also identify which components a specific and targeted PC intervention in HF should include and attempt to define the most relevant trial outcomes.
Methods:
An unselected, prospective, near-consecutive, cohort of patients admitted to hospital with acute decompensated HF will be enrolled over a 2-year period. All potential participants will be screened using B-type natriuretic peptide and echocardiography, and all those enrolled will be extensively characterized in terms of their HF status, comorbidity, and PC needs. Quantitative assessment of PC needs will include evaluation of general and disease-specific quality of life, mood, symptom burden, caregiver burden, and end of life care. Inpatient assessments will be performed and after discharge outpatient assessments will be carried out every 4 months for up to 2.5 years. Participants will be followed up for a minimum of 1 year for hospital admissions, and place and cause of death. Methods for identifying patients with HF with PC needs will be evaluated, and estimates of healthcare utilisation performed.
Conclusion:
By assessing the prevalence of these needs, describing how these needs change over time, and evaluating how best PC needs can be identified, we will provide the foundation for designing an RCT of a PC intervention in HF.
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