Figures
- FIGURE 1
BREATHE Study flowchart.
Tables
- TABLE 1
Schedule of events for patient-participants
Visit Call-out (baseline) 48 h Day 14 Day 30 Month 6 Day 0 2 (±0 days) 14 (±7 days) 30 (±7 days) 183 (±7 days) Procedure/assessment Inclusion/exclusion criteria assessment x Call-out informed consent x NRS 0–10 breathlessness every 2 min (patient) x Routinely collected paramedic data x Demographic measures (patient and carer) x Index ambulance call-out outcome x Further call-outs in 48 h after index call-out x Follow-up informed consent x Interview (patient and carer) x Health service utilisation questionnaire (patient) x x x SF-36 (patient) x x x CRQ-Dyspnoea Questionnaire (patient) x x x NRS: numerical rating scale; SF-36: Short Form 36; CRQ: Chronic Respiratory Questionnaire.
- TABLE 2
BREATHE intervention and usual care
Intervention Examples of techniques Supporting evidence Be reassured# Reassure patient and carer; a reassuring and expert presence is sometimes sufficient to start “unwinding” escalating breathlessness [25, 26] Resting position Check posture; find the most comfortable and efficient position to maximise ventilation [25, 27, 28] Exercises (breathing) Use to slow breathing rate and encourage breathing out to prevent air trapping (e.g. pursed lip or “breathing rectangle”); pursed lip breathing also provides increased end-expiratory pressure [25–29] Airflow Use hand-held fan; airflow across lower face/nasal passages can reduce breathlessness and recovery time [30–32] Time# “Take it easy, nice and slow”# [25–27] Help with fears and worries# Simple techniques to manage panic and fear# [25–27] Education of patient and carer Information booklet and laminated card with BREATHE intervention [25–28] Intervention points: a) the techniques are often simultaneously delivered and tailored to the individual
b) #: denotes anxiety-focused management
c) The laminated BREATHE card, the information booklet and hand-held fan will be packaged in a “BREATHE folder” for paramedics to take into the house of a breathless patient.
Usual care JRCALC Guidelines [21] Immediate clinical assessment History, baseline vital signs and targeted examination (e.g. chest auscultation, peak flow, 12-lead ECG) Reassurance Reassurance is a mainstay of high-quality patient care Oxygen Time critical feature: oxygen saturations of <94% or less for those patients without chronic lung diseases
Target range oxygen saturation in patients with chronic lung diseases: 88–92%
If SpO2 >92%, oxygen would not be administeredNebuliser Depending on the initial assessment, the paramedic may ask the patient to use their own inhalers, or proceed to nebulisation JRCALC: Joint Royal Colleges Ambulance Liaison Committee; ECG: electrocardiogram; SpO2: oxygen saturation.
- TABLE 3
Stop–go criteria
Recruitment Green If ≥80% of target patient-participants are recruited to target Amber Between ≥60% and <80% patient-participants recruited and remediable barriers identified and addressed in main trial protocol Red <60% of the estimated sample size for a full trial cannot be completed by 24 months Intervention adherence# Green ≥75% Amber ≥50 and <75%; possible if further modelled for the main trial protocol by addressing remediable factors Red <50%; it would be concluded that the intervention cannot be sufficiently implemented in practice and a main trial not possible Green: main trial feasible; amber: feasible with remediable factors addressed; red: main trial not feasible. #: eligible patient-participants attended by a paramedic allocated to and trained in the intervention received the intervention.
