Optimisation of Heart Failure Management in Nursing Homes Using Point-of-Care Ultrasonography: Harmonious Trial Rationale and Design

Figure 1

Figure 2

Study data collection list (HF – heart failure; NYHA – New York Heart Association classification; HFrEF – heart failure with reduced ejection fraction; HFmrEF – heart failure with mid-range ejection fraction; HFpEF – heart failure with preserved ejection fraction)_

Category	Data variable	Measurement description	Data source
Demographic data	Age	In full years	Medical record
	Gender	Male or female	Medical record
Baseline clinical characteristics	Multimorbidity	Yes if more than 2 chronic diseases	Medical record
	Charlson Comorbidity Index	Using MDCalc software	Medical record
	Previously diagnosed heart failure	Yes if any evidence	Medical record
	Current therapy	Number of all prescribed medicines	Medical record
	Start-point health barometer	Self-evaluated	Interview
	Start-point NYHA	On scale I–IV	Interview and clinical examination
	History of coronary artery disease	Yes if any evidence	Medical record
Clinical history	History of arterial hypertension	Yes if any evidence	Medical record
	Exposition to cardiotoxic drugs/radiation	Yes if any evidence	Medical record
	Use of diuretics	Yes if any evidence	Medical record
	Orthopnoea / paroxysmal nocturnal dyspnoea	Yes if declared or any evidence	Interview or medical record
Signs of heart failure	Rales	Yes if bilateral	Clinical examination
	Bilateral ankle oedema	Yes if bilateral	Clinical examination
	Heart murmur	Yes if heard	Clinical examination
	Jugular venous dilatation	Yes if observed in sitting position	Clinical examination
	Laterally displaced / broadened apical beat	Yes if felt	Clinical examination
Diagnostics of heart failure	ECG	Any abnormality	Study
	NT-proBNP	Positive if ≥125 pg/mL	Study
	Echocardiography	Categorisation in HFrEF, HFmrEF, HFpEF	Study
Outcomes	Events related to HF deterioration	The need for the iv diuretic, the emergency service intervention, hospitalisations for non-injury cause or death	Study
	Days to deterioration of heart failure	For any event related to HF deterioration	Study
	Change in health barometer	Self-evaluated	Study
	Change in NYHA class	On scale I–IV	Study
	Days in hospital due to heart failure	For HF deterioration only	Study
	Days alive and out of hospital	Excluding hospital days for whatever cause	Study
Workload	Days alive	Time to death for whatever cause	Study
	Non-administrative contacts	All and HF related	Study
	Therapy modifications	All and HF related	Study
	Unplanned referrals	All and HF related	Study

Inferior vena cava diameter and collapsibility evaluation (adapted and modified from Kircher, et al_ (22) and Papadimos, et al_ (23))_

Category	Estimated inferior vena cava diameter	Collapsibility	Estimated central venous pressure
Small	<1.5 cm	>50%	0–5 mm Hg
Medium	1.5–2.5 cm	>50%<50%	6–10 mm Hg11–15 mm Hg
Large	>2.5 cm	<50%	>16 mm Hg

Follow-up plan_

	Test-retest reliability	At inclusion	At inclusion	At inclusion	At inclusion	At inclusion
Intervention group	Physical examination	+	+	+	+	-
	POCUS	+	+	+	+	-
	Evaluation of HF deteriorations	+	+	+	+	+
Control group	Physical examination	+	+	+	+	-
	POCUS	+	-	-	-	-
	Evaluation of HF deteriorations	+	+	+	+	+