Launching an Asthma Initiative Designed to Improve Asthma Management and Outcomes

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02140671
• Other study ID #: ORO3112
• Status: Active, not recruiting
• Phase: N/A
• First received: May 14, 2014
• Last updated: May 14, 2014
• Start date: May 2012
• Est. completion date: August 2015

Study information

• Verified date: May 2014
• Source: Research in Real-Life Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines Healthcare Products Regulatory Agency
• Study type: Observational

Clinical Trial Summary

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.

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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 33370
• Est. completion date: August 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 65 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Research in Real-Life Ltd	British Lung Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	1. Accident and Emergency (A&E) attendance		1 year	No
Other	2. Proportion of patients on each asthma register that have a confirmed asthma diagnosis		1 year	No
Other	3. Proportion of patients with an asthma management plan		1 year	No
Other	4. Proportion of patients with a recorded asthma control test (ACT) and Royal College of Physician three questions (RCP3)		1 year	No
Primary	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	No
Secondary	1. Increased assessment of patients with equivocal diagnoses and reduction of diagnostic doubt (also detailed under process outcomes)		1 year	No
Secondary	2. Hospitalisations ¬- number and rate - coded for: • Asthma • Lower respiratory conditions (including asthma), i.e. "asthma-related" events		1 year	No
Secondary	3. Inhaled corticosteroids adherence		1 year	No
Secondary	4. Referral rate of high-risk patients to local specialist		1 year	No
Secondary	5. British Asthma Guideline adherence: appropriate step-wise management of patients		1 year	No

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