Addressing the burden of respiratory disease in General Practice: A real-life implementation study focusing on high risk asthma and COPD patients

Study type

• Study type:
  Not applicable
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

  Drug utilisation

  Effectiveness study (incl. comparative)
• If ‘Not applicable’, further details on the study type:
  Interventional real-world cluster-randomised study

Study drug and medical condition

• Medical condition to be studied:
  Chronic obstructive pulmonary disease

  Asthma

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  2748

Study design details

• Main study objective:
  To identify patients with a COPD and/or asthma diagnosis at high risk of exacerbation utilising technology to support improved disease management by primary care providers and reduce the high-cost burden of respiratory events on the health care system by preventing otherwise avoidable hospitalisations.
• Outcomes:
  For asthma exacerbations, a 20% reduction in exacerbations is anticipated. For COPD exacerbations, a 20% reduction in exacerbations is anticipated. Time to first, and rate of, asthma-related crisis events for at-risk patients. The percentage of all registered asthma patients with an asthma-related crisis event, their rate of, and time to, first asthma-related crisis events.
• Data analysis plan:
  The OPC Clinical Audit consists of an electronic clinical audit using secure and confidential patient data from GP sites. Patients with asthma and/or COPD including a screen for undiagnosed COPD will be included. Patient-reported outcomes will be collected for identified high-risk asthma and COPD patients. A list of patients at risk of exacerbation or that have undiagnosed COPD will be generated (re-identified) and invited to the study as part of the Audit Group. A face-to-face review of the re-identified high-risk patients with the practice nurse followed up with a consultation with the GP utilising clinical decision support advice from OPC.