Clinical trial NCT02140671: Launching an Asthma Initiative Designed to Improve Asthma Management and Outcomes
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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma
Keywords: asthma management
anti-inflammatory therapy
compliance
hospital admission
educations
self-management
guidelines
exacerbations
diagnostic accuracy
symptom control
Lead sponsor: Research in Real-Life Ltd
Sponsor class: NETWORK
Collaborators: name: British Lung Foundation
First posted: 2014-05-16
Enrollment: 33370
Sex: ALL
Minimum age (years): 3
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

Brief 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.

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)

Eligibility criteria: 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:

-

Primary outcomes:
measure: Exacerbations reduction
timeFrame: 1 year
Secondary outcomes:
measure: 1. Increased assessment of patients with equivocal diagnoses and reduction of diagnostic doubt (also detailed under process outcomes)
timeFrame: 1 year
measure: 2. Hospitalisations ¬- number and rate - coded for: • Asthma • Lower respiratory conditions (including asthma), i.e. "asthma-related" events
timeFrame: 1 year
measure: 3. Inhaled corticosteroids adherence
timeFrame: 1 year
measure: 4. Referral rate of high-risk patients to local specialist
timeFrame: 1 year
measure: 5. British Asthma Guideline adherence: appropriate step-wise management of patients
timeFrame: 1 year
Other outcomes:
measure: 1. Accident and Emergency (A&E) attendance
timeFrame: 1 year
measure: 2. Proportion of patients on each asthma register that have a confirmed asthma diagnosis
timeFrame: 1 year
measure: 3. Proportion of patients with an asthma management plan
timeFrame: 1 year
measure: 4. Proportion of patients with a recorded asthma control test (ACT) and Royal College of Physician three questions (RCP3)
timeFrame: 1 year
Locations:
Study officials:
affiliation: Reasearch in Real Life Ltd
name: David Price
role: PRINCIPAL_INVESTIGATOR
References: