PrimaryBreathe trial: Evaluating a primary care intervention for chronic breathlessness – a randomised controlled trial.
Specialty: General Practice, Primary sub-specialty: General Practice; Health Category: Cardiovascular, Respiratory; Disease/Condition: Symptoms and signs involving the circulatory and respiratory systems
Mixed-methods explanatory sequential design with two main components: Randomised Controlled Trial (RCT) and Qualitative Parallel Process Evaluation (QPPE). Recruitment: This study will recruit approximately 33 practices and 10 eligible patients from each to the RCT. Participants will provide written informed consent either online or via post. Following this, each participant's eligibility will be confirmed before they are randomised to intervention (PrimaryBreathe treatment) or routine care (control). After randomisation, patients in both arms will be checked for medical optimisation of the underlying long-term condition(s) causing chronic breathlessness, using disease-specific checklists (OptiMed). The intervention arm involves participants receiving the PrimaryBreathe intervention as well as OptiMed; those in the control arm receive OptiMed alone. Consented participants in the intervention arm will be provided with the PrimaryBreathe treatment from a trained health-professional participant. All patient and health professional participants will be invited to complete questionnaires. The qualitative parallel process evaluation (QPPE) will involve approximately eight diverse general practices taking part in the RCT. There are six types of participants in the trial: health professionals delivering the intervention (a minimum of 33, at least one per site), patients (the largest group of 330), informal carers, non-participating patients who decline to take part in the RCT but are willing to share their reasons with the research team, general practice staff involved in administrative activities, and Cambridge Breathlessness Intervention Service (CBIS) staff. The latter four groups will be invited to participate in QPPE only. Each of these participant types will be consented in turn. 1. RCT Health Professionals (HP) This study will recruit approximately 33 GP practices from at least four of the 12 RRDN regions of England. Each practice will identify at least one member
General practice site eligibility 1. Located in England’s Regional Research Delivery Network (RRDN) regions 2. Practice uses either SystmOne or EMIS (also known as Optum) electronic medical record software, AND 3. At least one eligible health professional working clinically in the practice is interested in delivering the intervention, AND 4. One General Practitioner (GP) at the practice is willing to oversee the study as site Principal Investigator (PI). Trial participants Health professional eligibility 1. Working clinically within a participating general practice, AND 2. Interested in delivering the intervention, AND 3. Considered by the site PI to have sufficient skill and enthusiasm to be suitable to deliver the intervention after training, AND 4. Registered health professional OR a Health and Wellbeing Coach. Patient eligibility 1. Registered at a participating general practice, AND 2. Aged 18 years or over, AND 3. Able to give informed consent, AND 4. Experiencing chronic breathlessness on exertion or at rest for at least 8 weeks with one or more of the index long term conditions (LTCs), diagnosed in primary or secondary care, being a major contributor to the patient’s experience of chronic breathlessness, AND 5. Modified MRC scale self-assessment score of 2-4. Qualitative parallel process evaluation participants General practice staff eligibility 1. Health professional participant in the trial OR involved in the administrative delivery of the trial at a participating site through their professional role, AND 2. Able to provide informed consent, AND 3. Aged 18 years or over. Patient eligibility 1. Patient participant in the trial intervention arm Carer eligibility 1. Aged 18 years or over, AND 2. Able to provide informed consent, AND 3. Identified as a family member or friend giving support (unpaid/family carer) by a patient participant in the trial intervention arm. Patient non-participant eligibility 1. Invited to participate as patient participant i
General practice site eligibility 1. Participated in the PrimaryBreathe intervention co-design study or the PrimaryBreathe feasibility study Trial participants 1. Health professional eligibility 2. Working exclusively as a Health Care Assistant with no other registered profession(s) Patient eligibility 1. Likely to be in the last three months of life, OR 2. Known acute on chronic deterioration in breathlessness over preceding days or a small number of weeks, OR 3. Known ICU admission in the three months prior to recruitment, OR 4. Known major surgery during the preceding four weeks or scheduled within the next three months after recruitment, OR 5. A symptom-directed intervention is inappropriate for the individual, for example, they do not have the cognitive capacity to benefit and/or engage with study interventions, OR 6. Considered unable to complete study measures, OR 7. Patient is housebound Qualitative parallel process evaluation participants General practice staff eligibility 1. Not meeting the key exclusion criteria Patient eligibility 1. Not meeting the key exclusion criteria Carer eligibility 1. Patient participant does not agree to carer inclusion Patient non-participant eligibility 1. Not meeting the key exclusion criteria CBIS staff eligibility 1. Not meeting the key exclusion criteria