Pragmatic evaluation of a quality improvement programme for people living with modifiable high-risk chronic obstructive pulmonary disease
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)RespiratoryOther chronic obstructive pulmonary disease
- Registration Number
- ISRCTN15819828
- Lead Sponsor
- Observational & Pragmatic Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 1512
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
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 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.<br> 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, respiratory hospitalisation), at baseline, 12, 24 and 30 months. All outcome data will be analysed retrospectively at the end of the trial.<br>
- Secondary Outcome Measures
Name Time Method 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.