Strategies to address the shortcomings of commonly used advanced chronic heart failure descriptors to improve recruitment in palliative care research: A parallel mixed-methods feasibility study

Abstract

Background: Recruitment challenges contribute to the paucity of palliative care research with advanced chronic heart failure patients.

Aim: To describe the challenges and outline strategies of recruiting advanced chronic heart failure patients.

Design: A feasibility study using a pre-post uncontrolled design.

Setting: Advanced chronic heart failure patients were recruited at two nurse-led chronic heart failure disease management clinics in Ireland Results: Of 372 patients screened, 81 were approached, 38 were recruited (46.9% conversion to consent) and 25 completed the intervention. To identify the desired population, a modified version of the European Society of Cardiology definition was used together with modified New York Heart Association inclusion criteria to address inter-study site New York Heart Association classification subjectivity. These modifications substantially increased median monthly numbers of eligible patients approached (from 8 to 20) and median monthly numbers recruited (from 4 to 9). Analysis using a mortality risk calculator demonstrated that recruited patients had a median 1-year mortality risk of 22.7 and confirmed that the modified eligibility criteria successfully identified the population of interest. A statistically significant difference in New York Heart Association classification was found in recruited patients between study sites, but no statistically significant difference was found in selected clinical parameters between these patients.

Conclusion: Clinically relevant modifications to the European Society of Cardiology definition and strategies to address New York Heart Association subjectivity may help to improve advanced chronic heart failure patient recruitment in clinical settings, thereby helping to address the paucity of palliative care research this population.

Keywords: Heart failure; palliative care; patient-reported outcome measures; recruitment.

Figure 1.

Adaptation of the European Society of Cardiology’s advanced chronic heart failure definition for the study inclusion criteria. CHF: chronic heart failure; HF: heart failure; NYHA: New York Heart Association; LVEF: left ventricular ejection fraction; PCWP: pulmonary capillary wedge pressure; RAP: right atrial pressure; BNP: brain natriuretic peptide; NT: Nterminal; 6-MWT: 6-minute walk test; VO₂: oxygen consumption; CRT: cardiac resynchronisation therapy; HFrEF: Heart Failure with Reduced Ejection Fraction; HFpEF: Heart Failure with Preserved Ejection Fraction; HF CNS: Heart Failure Clinical Nurse Specialist. *Essential inclusion criteria. ^†Source: Metra et al.

Figure 2.

Modified CONSORT flow diagram showing patient recruitment. ACHF: advanced chronic heart failure.

Figure 3.

Number of patients recruited per month before and after change in NYHA inclusion criteria. *Patients who were currently assigned NYHA II functional class but had recently been assigned NYHA functional class III or IV were included.

Figure 4.

American College of Cardiology–American Heart Association (ACC-AHA) CHF stage and NYHA functional classification of Heart Failure. CHF: chronic heart failure; NYHA: New York Heart Association.