Chronic Obstructive Pulmonary Disease (COPD) Respiratory Other chronic obstructive pulmonary disease
Conditions
Interventions
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
any consultations will be part of quality improvement activ
Sponsors
Observational & Pragmatic Research Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 ß2 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 ß2 agonist (LABA), long-acting muscarinic antagonist (LAMA) or inhaled corticosteroid (ICS), or on dual therapy with LAMA-LABA or ICS-LABA
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcomes as of 28/07/2026: The annual rate of moderate or severe exacerbations during the outcome evaluation period (average of 24 months) is measured using electronic medical records data (prescription of oral corticosteroids and/or antibiotics or hospital visits/admissions following a respiratory event). All outcome data will be analysed retrospectively at the end of the trial. Previous primary outcomes: 1. The annual rate of moderate or severe exacerbations is measured using electronic medical records data (prescription of oral corticosteroids and/or antibiotics or hospital visits/admissions following a respiratory event) at baseline, 12, 24, and 30 months. All outcome data will be analysed retrospectively at the end of the trial. 2. The annual rate of major cardiac or respiratory events is measured using electronic medical records data (new diagnosis/hospitalisation for heart failure, coronary artery revascularization, myocardial infarction, stroke, cardiac/respiratory death, or respiratory hospitalization) at baseline, 12, 24, and 30 months. All outcome data will be analysed retrospectively at the end of the trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcomes as of 28/07/2026: The annual rate of major cardiac or respiratory events, total annual systemic corticosteroid exposure, and incident type 2 diabetes during the outcome evaluation period (average of 24 months) is measured using electronic medical records data (average annual dose of prednisolone taken via any systemic route). All outcome data will be analysed retrospectively at the end of the trial. Previous secondary outcomes: Total annual systemic corticosteroid exposure is measured using electronic medical records data (average annual dose of prednisolone taken via any systemic route) at baseline, 12, 24, and 30 months. All outcome data will be analysed retrospectively at the end of the trial. | — |
Countries
England, United Kingdom
Outcome results
None listed