Launching an Asthma Initiative Designed to Improve Asthma Management and Outcomes

To Deliver a Pilot Project on Effective Interventions to Ensure: Diagnostic Accuracy, Management of Risk and Control and Self-management for Asthma Patients.

Following on from a 10 year study conducted in Finland this study is designed to test the validity and sustainability of an enhanced asthma management model for the UK.

Study Overview

• Status: Unknown
• Conditions: Asthma

Detailed Description

The British Lung Foundation (BLF) aims to work with the governments in the four UK nations to launch an asthma initiative designed to improve asthma management and outcomes. The project incorporates key learning from a 10 year programme in Finland designed to improve asthma care and cap healthcare costs for paediatric and adult populations.

The Finland programme focused on accurate diagnosis, training and education of healthcare professionals and patients and early use of anti-inflammatory therapy. The programme successfully improved medication compliance, reduced asthma hospital admissions, reduced asthma-related benefit claims and reduced the overall cost of asthma to the Finnish Government.

To test the validity and sustainability of an enhanced asthma management model for the UK, the BLF proposes to undertake a pilot initiative in England. The pilot will focus on: improving diagnostic accuracy through analysis of GP asthma registers; increasing asthma education among healthcare professionals; assessment of risk and control of patient's asthma; supportive self-management and education of people with asthma.

It is anticipated that the pilot will lead to measureable and significant improvements in asthma management, including:

• Reduced number of severe exacerbations (asthma hospitalisation, A&E attendance and oral steroid rescue)
• Improved diagnostic accuracy (and reduction of diagnostic doubt)
• Improved implementation of recognised asthma guidelines, including appropriate step wise management of patients

The pilot will also aim to increase the proportion of patients on the asthma register with an asthma management plan and a recorded asthma control test therefore supporting higher levels of control, and will promote peer-to-peer health care professional asthma education and knowledge sharing to establish an asthma-training legacy.

The pilot model will be sustainable and reproducible across England and the devolved nations (Scotland, Wales and Northern Ireland). Whilst the core aspects of an agreed national model will be rolled out across the pilot site, it will be tailored and refined through local collaboration (primary care, secondary care and commissioners) to help attain local targets in line with regional differences, needs and priorities.

Results from the pilot will be reported 15 months after project initiation on site (July/August 2014)

• Study Type: Observational
• Enrollment (Anticipated): 33370

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The patient questionnaire will be subject to local refinement in line with local needs, targets and priorities but will assess -

• Asthma Control e.g. ACT, or ACQ or RCP3
• Lifestyle - i.e. smoking status
• Comorbidities
• Patient perceived adherence
• Side effects

The practice and patient reports will be used to characterise the patient in terms of risk and control. They will give a complete picture of the patient's asthma and will be used to identify patients for diagnostic assessment, medical management and education. Patients will then be stratified into Group 1 (patients with asthma) or Group 2 (Patients identified for further diagnostic assessment and/or with diagnostic doubt).

Description

Inclusion Criteria:

• Motivated and driven local champions in the area
• High rates of hospital admissions (aged 3-65)
• High asthma prevalence
• High percentage of patients who have had an asthma review in the previous 15 months.

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patients with an asthma diagnosis
Patients where there is diagnostic doubt

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exacerbations reduction	An exacerbation is defined (in line with the European Respiratory Society/American Thoracic Society guidelines) as: acute oral steroids, out of hours or Accident and Emergency (A&E) attendance for asthma, or hospitalisation for asthma. Rationale for selecting exacerbations as the primary outcome: They are the time of greatest risk to patients and greatest resource use; Exacerbations are defined by routinely held data, such as drug prescriptions (oral steroids and out of hours and A&E attendance), hence are reliable when captured in primary care; Exacerbations reflect current control and future risk; a reduction in exacerbations indicates an improvement in asthmatic inflammation control and improved use of anti-inflammatory therapy	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
1. Increased assessment of patients with equivocal diagnoses and reduction of diagnostic doubt (also detailed under process outcomes)	1 year
2. Hospitalisations ¬- number and rate - coded for: • Asthma • Lower respiratory conditions (including asthma), i.e. "asthma-related" events	1 year
3. Inhaled corticosteroids adherence	1 year
4. Referral rate of high-risk patients to local specialist	1 year
5. British Asthma Guideline adherence: appropriate step-wise management of patients	1 year

Other Outcome Measures

Outcome Measure	Time Frame
1. Accident and Emergency (A&E) attendance	1 year
2. Proportion of patients on each asthma register that have a confirmed asthma diagnosis	1 year
3. Proportion of patients with an asthma management plan	1 year
4. Proportion of patients with a recorded asthma control test (ACT) and Royal College of Physician three questions (RCP3)	1 year

Collaborators and Investigators

• Sponsor: Research in Real-Life Ltd
• Collaborators: British Lung Foundation
• Investigators: Principal Investigator: David Price, Reasearch in Real Life Ltd

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Anticipated): August 1, 2014
• Study Completion (Anticipated): August 1, 2015

Study Registration Dates

• First Submitted: May 14, 2014
• First Submitted That Met QC Criteria: May 14, 2014
• First Posted (Estimate): May 16, 2014

Study Record Updates

• Last Update Posted (Estimate): May 16, 2014
• Last Update Submitted That Met QC Criteria: May 14, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: compliance; asthma management; anti-inflammatory therapy; hospital admission; educations; self-management; guidelines; exacerbations; diagnostic accuracy; symptom control
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: ORO3112

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No