Steroid Withdrawal Intervention in Fife and Tayside

NCT ID: NCT03489746

Last Updated: 2023-03-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2022-12-31

Brief Summary

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

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Inhaled corticosteroid withdrawal

Patients meeting the study criteria for withdrawal will have their ICS containing regime changed to a LABA/LAMA regime without ICS.

Group Type: EXPERIMENTAL

ICS withdrawal protocol

Intervention Type: OTHER

A primary care intervention to support switch from ICS containing regimen to non-ICS containing regimen in appropriate patients.

Standard care

Patients will continue on their current recommended regimen including ICS.

Group Type: ACTIVE_COMPARATOR

Standard care

Intervention Type: OTHER

Normal clinically indicated inhaled therapy

Interventions

ICS withdrawal protocol

A primary care intervention to support switch from ICS containing regimen to non-ICS containing regimen in appropriate patients.

Intervention Type: OTHER

Standard care

Normal clinically indicated inhaled therapy

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NHS Fife

OTHER_GOV

Sponsor Role: collaborator

NHS Tayside

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philip M Short

Role: PRINCIPAL_INVESTIGATOR

NHS Tayside

Devesh Dhasmana

Role: PRINCIPAL_INVESTIGATOR

NHS Fife

Arlene Shaw

Role: STUDY_DIRECTOR

NHS Tayside

Fiona Eastop

Role: STUDY_DIRECTOR

NHS Tayside

Locations

NHS Tayside

Dundee, Perthshire, United Kingdom

NHS FIfe

Kirkcaldy, , United Kingdom

Countries

United Kingdom

Other Identifiers

2016RC23

Identifier Type: -

Identifier Source: org_study_id