Breathlessness relief at home

Conditions

Breathlessness as a result of either COPD, bronchitis, asthma, bronchiectasis, emphysema, heart disease or cancer in the lungs Respiratory

Anne Hutchinson, Victoria Allgar, Judith Cohen, David C. Currow, Susan Griffin et al. (13 authors)

ERJ Open Research2022-08-2410 citations

10.1183/23120541.00257-2022

OP08 A feasibility cluster randomised controlled trial of a paramedic-administered breathlessness management intervention for acute-on-chronic breathlessness (BREATHE): study findings

Anne Hutchinson, Victoria Allgar, Judith Cohen, David C. Currow, Susan Griffin et al. (12 authors)

Emergency Medicine Journal2022-08-23

10.1136/emermed-2022-999.8

Interventions

A group of paramedics (paramedic-participants) will be randomised to either deliver usual care or adopt the BREATHE intervention into routine practice for breathlessness patients. These paramedics wil

initial history, baseline vital signs and tailored examination (chest auscultation, peak flow readings, 12-lead ECG). BREATHE intervention: In additional to usual care

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Paramedic-participants: 1. From a participating ambulance stations 2. Able to provide informed consent 3. Willing to undergo training and to deliver intervention if so randomised 4. Willing to undergo training to participate in study measures and processes Patient-participants: 1. In their normal home environment experiencing a breathlessness crisis and receiving a 999 ambulance response from participating paramedics 2. Who do not require immediate life-saving intervention/transfer to ED in the opinion of the attending paramedic 3. Call-out due to breathlessness 4. Who experience chronic breathlessness (defined as short of breath most days in the last 3 months or longer) 5. With a self-reported diagnosis of a cardiorespiratory disease (including lung cancer [primary or secondary], COPD, bronchitis, asthma, bronchiectasis, emphysema, heart disease 6. Able to give retrospective consent at the end of the paramedic call-out to use collected data for researcher use Carer-participants: If any of the patient-participants who consent to the interview have a carer, the carer will be invited to be part of the interview

Exclusion criteria

Exclusion criteria: Paramedic-participants: 1. Failure of inclusion criteria Patient-participants: 1. Patients requiring urgent disease-directed intervention and transfer to the ED for acute pathology in the opinion of the attending paramedic 2. Patient does not have capacity to provide retrospective consent 3. Patient is currently enrolled on the trial or has previously participated

Design outcomes

Primary

Measure	Time frame
Feasibility outcomes related to paramedics: 1. Paramedic recruitment rate recorded as the number of eligible paramedics who consent to participate in the study 2. Paramedic attrition rate recorded as the number of paramedics who consent to participate that remain in the study until the end of recruitment 3. Willingness of paramedics to be randomised recorded as number of paramedic declining participation for this reason 4. Patient recruitment per paramedic recorded as number of patients recruited by each paramedic Feasibility outcomes related to patients: 1. Patient recruitment rate recorded as the number of eligible patients who consent to participate to Day 0 data use 2. Patient consent rate for follow-up data provision recorded as the number of patients who consent to Day 0 data use who also consent to follow-up 3. Patient attrition rate recorded as the number of patients who consent to participate in follow-up that remain in the study until the end of follow-up	—

Measure

Time frame

Feasibility outcomes related to paramedics: 1. Paramedic recruitment rate recorded as the number of eligible paramedics who consent to participate in the study 2. Paramedic attrition rate recorded as the number of paramedics who consent to participate that remain in the study until the end of recruitment 3. Willingness of paramedics to be randomised recorded as number of paramedic declining participation for this reason 4. Patient recruitment per paramedic recorded as number of patients recruited by each paramedic Feasibility outcomes related to patients: 1. Patient recruitment rate recorded as the number of eligible patients who consent to participate to Day 0 data use 2. Patient consent rate for follow-up data provision recorded as the number of patients who consent to Day 0 data use who also consent to follow-up 3. Patient attrition rate recorded as the number of patients who consent to participate in follow-up that remain in the study until the end of follow-up

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Secondary

Measure	Time frame
Other feasibility outcomes: 1. Data quality of routinely collected and patient/proxy reported data recorded as completeness of data at Day 0 and 48-hour post-call-out data 2. Data quality of patient-reported outcomes recorded as completeness of questionnaire completion at 14 days, 1 month and 6 months 3. Intervention fidelity recorded as elements of BREATHE intervention used by the paramedic during Day 0 call-out 4. Patient adherence to the BREATHE intervention recorded as how they take part in the intervention in the call-out on Day 0 5. Acceptability of the BREATHE intervention to the patients is reported from qualitative analysis of interviews at 14 days post call out 6. Acceptability of the BREATHE intervention to the paramedics is recorded by Process evaluation and qualitative interviews at end of recruitment 7. Use of BREATHE intervention by patient since initial visit on Day 0 is reported from qualitative analysis of interviews at 14 days post call out and Health service utilisation questionnaires at 1 month and 6 months 8. Intracluster coefficient and sample size calculation for candidate primary outcomes Potential definitive trial primary outcomes: 1. Improvement in breathlessness intensity at end of paramedic visit is measured by patient-participant report or paramedic-participant proxy report NRS intensity “now” every 2 minutes till decision to transfer to ED or decision to keep at home on Day 0 2. Conveyance to Accident & Emergency is being collected from routinely collected data at Day 0 Clinical measures: 1. Paramedic routinely collected clinical and service delivery data (pulse, respiratory rate, blood pressure (systolic and diastolic), capillary blood oxygen saturation level (SPO2) with air, SPO2 with oxygen) recorded at first and last assessme	—

Measure

Time frame

Other feasibility outcomes: 1. Data quality of routinely collected and patient/proxy reported data recorded as completeness of data at Day 0 and 48-hour post-call-out data 2. Data quality of patient-reported outcomes recorded as completeness of questionnaire completion at 14 days, 1 month and 6 months 3. Intervention fidelity recorded as elements of BREATHE intervention used by the paramedic during Day 0 call-out 4. Patient adherence to the BREATHE intervention recorded as how they take part in the intervention in the call-out on Day 0 5. Acceptability of the BREATHE intervention to the patients is reported from qualitative analysis of interviews at 14 days post call out 6. Acceptability of the BREATHE intervention to the paramedics is recorded by Process evaluation and qualitative interviews at end of recruitment 7. Use of BREATHE intervention by patient since initial visit on Day 0 is reported from qualitative analysis of interviews at 14 days post call out and Health service utilisation questionnaires at 1 month and 6 months 8. Intracluster coefficient and sample size calculation for candidate primary outcomes Potential definitive trial primary outcomes: 1. Improvement in breathlessness intensity at end of paramedic visit is measured by patient-participant report or paramedic-participant proxy report NRS intensity “now” every 2 minutes till decision to transfer to ED or decision to keep at home on Day 0 2. Conveyance to Accident & Emergency is being collected from routinely collected data at Day 0 Clinical measures: 1. Paramedic routinely collected clinical and service delivery data (pulse, respiratory rate, blood pressure (systolic and diastolic), capillary blood oxygen saturation level (SPO2) with air, SPO2 with oxygen) recorded at first and last assessme

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Countries

England, United Kingdom

Outcome results

None listed