A 3-year cluster randomised controlled trial of the impact of a quality improvement and clinical decision support package versus usual care for patients with modifiable high-risk chronic obstructive pulmonary disease with or without a current diagnosis.
Chronic Obstructive Pulmonary Disease (COPD)
Enrolled practices will be randomised in a 1:1 ratio (using permuted blocks of different sizes) to either the intervention or control arm of the trial. Practices in the control arm will continue their usual patient care during the trial, and will receive the intervention at the end of the study period. Practices in the intervention arm will participate in a COPD quality improvement package, supporting healthcare professionals in primary care to diagnose, assess, and optimise the management of their patients with modifiable high-risk COPD, through the promotion of guideline-based care. Modifiable high-risk patients are those whose medical history of COPD exacerbations (flare-ups of disease), or history of smoking and respiratory symptoms and infections for those who do not have a COPD diagnosis, put them at a higher risk of exacerbations and cardiac or respiratory illness in the future. We describe this as a ‘modifiable’ risk because, with appropriate management, the risk may be modified and reduced. The intervention consists of four main components: i) identification of patients with modifiable high-risk COPD, ii) assessment of disease/quantification of future risk, iii) pharmacological/non-pharmacological treatment, iv) clinical follow up. Each practice will receive support and resources to deliver the intervention, including: clinical support to undertake clinic assessments, a spirometry service for patient lung function testing, patient questionnaires exploring respiratory symptoms and health and, individualised patient quality improvement reports based on guidelines. As a cluster randomised trial of a quality improvement intervention, patients will not be required to attend any research study visits; any consultations will be part of quality improvement activities undertaken by practices as part of guideline-recommended care and treatment. Participating practices in both the intervention and control arms will be required to contribute anonymised and de-id
Criteria for participants (primary care practices): 1. Primary care (GP) practice in England 2. Has a minimum of 12 modifiable “high-risk” COPD patients Modifiable high-risk patients suitable for quality improvement programme: Diagnosed COPD at baseline, i.e., “already-diagnosed”: 1. Diagnosed with COPD at trial baseline 2. Aged 40 years or older at trial baseline 3. In baseline period: two or more moderate, or one or more severe, exacerbations in the 24 months preceding randomization, including at least one exacerbation in the last 12 months 4. Therapy at baseline: no therapy, on a short-acting bronchodilator (SABA, SAMA or SABA-SAMA), on monotherapy with a long-acting β2 agonist (LABA), long-acting muscarinic antagonist (LAMA) or inhaled corticosteroid (ICS), or on dual therapy with LAMA-LABA or ICS-LABA Undiagnosed patients with potential modifiable high-risk COPD: 1. No diagnosis of COPD at trial baseline 2. Aged 40 years or older by trial baseline 3. Current smoker, or ex-smoker with a significant smoking history (10+ years smoking duration or 10+ pack-years) 4. In baseline period: two or more moderate, or one or more severe exacerbations of potential COPD in the 24 months preceding randomization, including at least one exacerbation in the last 12 months 5. Therapy at baseline: no therapy, on a short-acting bronchodilator (SABA, SAMA or SABA-SAMA), on monotherapy with a long-acting β2 agonist (LABA), long-acting muscarinic antagonist (LAMA) or inhaled corticosteroid (ICS), or on dual therapy with LAMA-LABA or ICS-LABA
Criteria for participants (primary care practices): 1. Practices that are in the process of, or planning to change the electronic medical records system (also called GP clinical system) or practice ownership within the study period 2. Practices engaged in active research studies or COPD related Quality Improvement Programs which might impact the ability to implement the quality improvement programme (intervention) Modifiable high-risk patients (diagnosed and undiagnosed COPD) not suitable for quality improvement programme: 1. Patients with a ‘consent refusal’ code in electronic medical records indicating opt-out for the usage of their data for research 2. Women who are pregnant at randomization or who become pregnant 3. Patients with a current asthma diagnosis and evidence of an asthma consultation in the last 24 months (applies to undiagnosed COPD only)