Breathlessness RElief AT HomE (BREATHE): a feasibility cluster randomised controlled trial (cRCT) to test if a definitive cRCT is possible to evaluate the effectiveness and cost-effectiveness of a paramedic-administered breathlessness crisis intervention for people with acute-on-chronic breathlessness compared with usual care

niversity of Hull0 个研究点目标入组 42 人开始时间: 2019年11月11日最近更新: 2022年12月5日

试验速览

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33816602/ (added 14/04/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36415651/ (added 24/11/2022)

•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

•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

发起方

niversity of Hull