Steroid Withdrawal Intervention in Fife and Tayside

Study Overview
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Brief Summary
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The SWIFT trial is a cluster randomised trial to determine if a patient identification, feedback and inhaled corticosteroid (ICS) withdrawal intervention in primary care can result in more appropriate inhaled corticosteroid use without increasing the frequency of exacerbations. Practices in Tayside and Fife will be randomised at practice level to an intervention or control. The intervention will consist of electronic review of patients Chronic obstructive pulmonary disease (COPD) data and prescribing history, followed by implementation of a medication change involving withdrawal of ICS and introduction of a Long acting beta adrenergic agonist (LABA) and Long acting muscarinic antagonist (LAMA) for patients without an indication for ongoing ICS treatment. Patients in control practices will not receive the intervention, but practices will be provided with local guidelines and formulary and encouraged to prescribe appropriately. Patients in the control practices may be switched to guideline compliant medications. Our hypothesis is that removal of non-evidence barriers to appropriate prescribing will result in in high rates of ICS withdrawal and that the intervention will be safe, as evidenced by no increase in the frequency of exacerbations over 12 months of follow-up.

Detailed Description
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Chronic obstructive pulmonary disease (COPD) is the third leading cause of death worldwide and a major cause of morbidity in the UK. Inhaled corticosteroids (ICS) are frequently prescribed to patients with COPD and these medications represent a major burden on the National Health Service in terms of drug costs. They are not without side effects, and pneumonia in particularly has been highlighted as a common adverse event in COPD patients receiving ICS. In the UK, inhaled corticosteroids are indicated for patients with severe or very severe COPD (Forced expiratory volume in 1 second <50% predicted) who experience frequent exacerbations. International guidelines and strategies such as those from Global Obstructive Lung Disease (GOLD), also suggest inhaled corticosteroids should be reserved for patients with frequent exacerbations despite appropriate treatment with inhaled bronchodilators such as combined long acting beta-agonists and long acting muscarinic antagonists (LABA/LAMA combinations). Despite this guidance, use of inhaled corticosteroids in patients with milder COPD and without a history of exacerbations is common. Randomised controlled trials suggest that inhaled corticosteroids can be withdrawn from COPD patients with minimal adverse effects. Attempts to reduce inappropriate ICS prescribing have been largely unsuccessful in real-life, however, because of non-evidence barriers. These include a lack of expertise in general practice to identify patients suitable for ICS withdrawal, fear of adrenal insufficiency, concern about missing a diagnosis of asthma and time. A high proportion of COPD care in the United Kingdom is delivered by specialist practice nurses, who may not be empowered to withdraw ICS in the absence of specific guidance or protocols. The SWIFT trial is a cluster randomised trial to determine if a patient identification, feedback and ICS withdrawal intervention in primary care can result in more appropriate inhaled corticosteroid use without increasing the frequency of exacerbations. Practices in Tayside and Fife will be randomised at practice level to an intervention or control. The intervention will consist of electronic review of patients COPD data and prescribing history, followed by implementation of a medication change involving withdrawal of ICS and introduction of a LABA/LAMA for patients without an indication for ongoing ICS treatment. Patients in control practices will not receive the intervention, but practices will be provided with local guidelines and formulary and encouraged to prescribe appropriately. Patients in the control practices may be switched to guideline compliant medications (which may include the withdrawal of inhaled corticosteroids). Our hypothesis is that the above non-evidence barriers will result in an ongoing high inappropriate use of ICS in control practices while an intervention that overcomes these will result in high rates of ICS withdrawal and that the intervention will be safe, as evidenced by no increase in the frequency of exacerbations over 12 months of follow-up. This study will make an important contribution to understanding the role of inhaled corticosteroids in COPD. If successful, the intervention could be safely applied throughout the NHS to reduce inappropriate medication use, reduce patient side effects and healthcare costs.

Official Title
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A Cluster Randomised Trial of Medication Review and Withdrawal of Inappropriate Inhaled Corticosteroid Treatment in Chronic Obstructive Pulmonary Disease

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Other: ICS withdrawal protocol
* Other: Standard care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients aged > 40 years A clinical diagnosis of COPD made by a physician Post-bronchodilator FEV1/FVC ratio at screening of <70% Exclusion Criteria: Asthma recorded in general practice records or clinically suspected Patients with COPD receiving inhaled short acting beta-2 agonist only. Residence outwith Tayside and Fife Insufficient data available to determine appropriateness of ICS and other medication use. Known previous failure of inhaled corticosteroid withdrawal Patients should be excluded if, in the opinion of the practice, making changes to their current COPD treatment regime is not in the patients best interests.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster randomized controlled trial at practice level
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inhaled corticosteroid withdrawal<br>Patients meeting the study criteria for withdrawal will have their ICS containing regime changed to a LABA/LAMA regime without ICS. | Other: ICS withdrawal protocol<br>* A primary care intervention to support switch from ICS containing regimen to non-ICS containing regimen in appropriate patients.<br>|
| Active Comparator: Standard care<br>Patients will continue on their current recommended regimen including ICS. | Other: Standard care<br>* Normal clinically indicated inhaled therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of moderate and severe exacerbations of COPD | Use of corticosteroids and/or antibiotics (moderate) or hospitalization (severe) for exacerbation of COPD | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory Hospitalizations |  | 1 year | 
| Success of ICS withdrawal | Inhaled corticosteroid prescribing rates (number of patients receiving inhaled corticosteroid prescriptions at study completion divided by total number of COPD patients) and withdrawal rates (number of patients receiving inhaled corticosteroids prior to the intervention divided by the number of patients receiving inhaled corticosteroids following the intervention in each arm) | 1 year | 
| Time to the first moderate and severe exacerbation | First exacerbation or respiratory hospitalisation following the intervention | Time to first event (patients without an event censored at 1 year) | 
| Oral corticosteroid use | Cumulative prescriptions for oral corticosteroids (excluding chronic low dose oral corticosteroids) | 1 year | 
| Antibiotic use | Cumulative prescriptions for oral antibiotics (excluding chronic low dose macrolides) | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inhaled corticosteroids, Quality improvement, Cluster randomized Trial