MISSION Severe Asthma Modern Innovative Solutions to Improve Outcomes in Severe Asthma.

Study Overview
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Brief Summary
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MISSION is a new and novel way of delivering highly specialised asthma care and has the potential to change the way asthma care across the United Kingdom (UK) is delivered as well as services for other long term health conditions. The MISSION model is the first model of this type and the current research study aims to evaluate its success and to compare the MISSION service to current care delivery. This will be done in several different ways. The study is a mixed methods evaluation of the new service comparing outcomes before and after the intervention using retrospective data analysis and prospective qualitative interview. A control arm of patients not exposed to, but eligible for, the new intervention will also be included. The study will be conducted at Portsmouth Hospitals National Health Service (NHS) Trust and will recruit patients who attended MISSION clinics, outpatient asthma clinics, staff who attended MISSION clinics in a professional capacity and patients from GP surgeries where MISSION clinics were held who did not attend.

Detailed Description
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Purpose and design The purpose of the study is to evaluate in detail the clinical and health economic outcomes from the MISSION project. The MISSION clinics combined a new way of delivering asthma care along with actively case finding patients who were not already known to specialist services but who had uncontrolled or at risk asthma. The aim of the study is to compare the MISSION clinic model outcomes to current clinic model outcomes as well as performing qualitative interviews with patients who attended and staff who took part in the project.The research study was developed by a team from Portsmouth Hospital Trust and the University of Portsmouth including a research fellow, consultant and Professor, research methodologist, qualitative senior lecturer and independent statistician. A patient adviser also reviewed the lay summary and patient information sheets. The study undergoes independent review by another clinician as part of the sponsor process. The study is also part of an MD project for the University of Portsmouth. Design: This is a mixed methods study. A quantitative analysis of data from patients who attended the MISSION Rapid Access Asthma Clinics (RAAC), patients who attended the MISSION Severe Asthma Assessment Clinics (SAAC), patients who were invited to the RAAC but did not attend and patients who have been referred by their GP to the severe asthma clinic during the same time MISSION was running. The data analysis will include asthma control, hospital admissions, GP appointments, related medical conditions,medications, investigations and assessments done and time between appointments. A qualitative study will be conducted using telephone interviews with patients who attended the SAAC and health care professionals who took part in the MISSION clinics. The aim is to recruit: 44 MISSION patients (of whom 20 attended both the RAAC and the SAAC), 132 patients who were invited to MISSION RAAC but did not attend 20 patients referred to the severe asthma clinic at the hospital 20 health care professionals who took part in the MISSION clinics Methodology: Participants will be approached for consent by post. They will be given time to read the information and return the consent form to the study team. They will be given a contact number to discuss any questions. Once a participant has consented to the quantitative study there is no further study procedures for the participant. Participants will be asked for consent to collect data from their GP and hospital records for the study. This will be entered onto a form (CRF) against a study number and then into a password protected study database held on a secure server at Portsmouth Hospitals NHS Trust. This data will then be analysed by a statistician and research fellow. Participants for qualitative interview will have an interview over the telephone lasting 45 minutes to one hour. This will be recorded and transcribed. The participant will be given the transcript to read and correct. The transcripts will then be analysed looking for themes.

Official Title
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MISSION Severe Asthma: Modern Innovative Solutions to Improve Outcomes in Severe Asthma. A Mixed Methods Observational Comparison of Clinical Outcomes in MISSION Versus Current Care Delivery.

Conditions
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Asthma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female, aged 18 years or above. Is in one of the following population groups: Attended the MISSION RAAC or Attended the MISSION SAAC or Identified as uncontrolled asthma by record searches and invited to MISSION RAAC but did not attend - 'primary care patients' or Has been referred to the specialist asthma clinic at Queen Alexandra Hospital - 'outpatient severe asthma patients' or Attended the MISSION RAAC or SAAC as a health care professional Participant is willing and able to give informed consent for participation in the study. Exclusion Criteria: The patient is unable or unwilling to give consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients who attended RAAC/SAAC.<br>Patients who have previously attended the Rapid Access Asthma Clinic (RAAC) will be approached for the quantitative study. Patients who went onto the attend the Severe Asthma Assessment Clinics (SAAC) will also be approached for the quantitative and qualitive parts of the study. | |
| Patients eligible for RAAC, but DNA'd<br>Patients identified by the GP search, who did not attend the previous MISSION clinics will be approached to participate in the quantitative part of the study. | |
| Asthma Outpatients<br>Patients who are attending outpatient clinics as new referrals will be approached to participate in the quantitative part of the study. | |
| Healthcare Professionals<br>Healthcare professionals who performed the MISSION RAAC or SAAC will be approached for qualitative interview part of the study only. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma control as measured by exacerbation frequency for all patients | The primary endpoint is asthma control as measured by exacerbation frequency (defined as deterioration in symptoms requiring ≥30mg prednisolone or equivalent for ≥3 days) for all patients | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short acting bronchodilator (SABA) use | Short acting bronchodilator (SABA) use measured by number of inhalers prescribed in 6 months pre and post MISSION SAAC, RAAC or outpatient clinic. | 6 months | 
| Exacerbation frequency | Exacerbation frequency (defined as deterioration in symptoms requiring ≥30mg prednisolone or equivalent for ≥3 days) in 6 months pre and post MISSION SAAC, RAAC or outpatient clinic. | 6 months | 
| Health care usage costs for asthma and number of contacts | Health care usage costs for asthma and number of contacts (GP visits, Emergency Department (ED) or out of hour attendances (OOH), hospital admissions, emergency GP visits) over 6 months pre and post MISSION or outpatient clinic. | 6 months | 
| Assessment of co-morbidity | Assessment of comorbidity (rhinosinusitis, anxiety and depression, dysfunctional breathing, gastro oesophageal reflux and obstructive sleep apnoea) and method of assessment for MISSION SAAC patients and outpatient severe asthma clinic patients | 6 months | 
| Assessment of inhaler technique and recommendations for inhaler devices. | Assessment of inhaler technique and recommendations for inhaler devices for MISSION SAAC patients and outpatient severe asthma clinic patients | 6 months | 
| Smoking cessation advice. | Smoking cessation advice for MISSION SAAC patients and outpatient severe asthma clinic patients | 6 months | 
| Investigations performed in secondary care | Investigations performed during 6 months in secondary care e.g. full lung function, sputum induction, High-Resolution Computed Tomography (HRCT) chest for MISSION SAAC patients and outpatient severe asthma clinic patients | 6 months | 
| Time from GP referral to 1st clinic visit | Time from GP referral to 1st clinic visit in secondary care for MISSION SAAC patients and outpatient severe asthma clinic patients | 6 months | 
| Time between 1st and 2nd visit | Time between 1st and 2nd visit in secondary care for MISSION SAAC patients and outpatient severe asthma clinic patients | 6 months | 
| Time to appointment with other specialists | Time to appoint with other specialists for asthma related comorbidity where indicated, e.g. dietician, Ear, Nose & Throat (ENT), physiotherapists, psychologist, CT imaging for MISSION SAAC patients and outpatient severe asthma clinic patients | 6 months | 
| Fractional Exhaled Nitric Oxide (FeNO) Assessment | Assessment of eosinophilic airways inflammation by FeNO for MISSION SAAC patients and outpatient severe asthma clinic patients | 6 months | 
| Frequency of non-attendance | The frequency of non-attendance at clinic for MISSION SAAC patients and outpatient severe asthma clinic patients | 6 months | 
| Severity of co-morbidities | Severity of co-morbidities for MISSION RAAC patients | 6 months | 
| Frequency of co-morbidities | Frequency of co-morbidities for MISSION RAAC patients | 6 months | 
| Frequency & type of allergy | Frequency & type of allergy for MISSION RAAC patients | 6 months | 
| Measurement of exhaled nitric oxide | Measurement of exhaled nitric oxide for MISSION RAAC patients | 6 months | 
| Measurement & variation of lung function (Single | Composite measurement & variation of lung function for MISSION RAAC patients | 6 months | 
| Frequency and type of additional asthma control medication. | Frequency and type of additional asthma control medication for MISSION RAAC patients | 6 months | 
| Quality of life | Quality of life as assessed by the Asthma Quality of Life Questionnaire (AQLQ). | 6 months | 
| Disease control | Disease control as assessed by the Asthma Control Questionnaire (ACQ) | 6 months | 
| Number of Forced Expiratory Volume at one second (FEV1) / Forced Vital Capacity (FVC) measurements | Number of patients having measurements of FEV1/FVC as a proxy for asthma control and severity in the MISSION RAAC patient and primary care patients | 6 months | 
| Prescription of SABA's | Prescription of Short Acting Bronchodilators (SABAs) during last 6 months at baseline and 6 months for MISSION RAAC and primary care patients. | 6 months previous | 
| Prescription of SABA's | Prescription of Short Acting Bronchodilators (SABAs) during last 6 months at baseline and 6 months for MISSION RAAC and primary care patients. | Baseline | 
| Prescription of SABA's | Prescription of Short Acting Bronchodilators (SABAs) during last 6 months at baseline and 6 months for MISSION RAAC and primary care patients. | 6 months | 
| Exacerbation rates | Exacerbation rates (defined as deterioration in symptoms requiring ≥30mg prednisolone or equivalent for ≥3 days) during the last 6 months at baseline and 6 months for MISSION RAAC and primary care patients. | 6 months previous | 
| Exacerbation rates | Exacerbation rates (defined as deterioration in symptoms requiring ≥30mg prednisolone or equivalent for ≥3 days) during the last 6 months at baseline and 6 months for MISSION RAAC and primary care patients. | Baseline | 
| Exacerbation rates | Exacerbation rates (defined as deterioration in symptoms requiring ≥30mg prednisolone or equivalent for ≥3 days) during the last 6 months at baseline and 6 months for MISSION RAAC and primary care patients. | 6 months | 
| ED attendances during the last 6 months | Emergency Department (ED) attendances during the last 6 months at baseline and 6 months for MISSION RAAC and primary care patients. | 6 months previous | 
| Out Of Hours (OOH) contacts during the last 6 months | Out Of Hours (OOH) contacts during the last 6 months at baseline and 6 months for MISSION RAAC and primary care patients. | 6 months previous | 
| Hospital admissions during the last 6 months | Emergency Department (ED) attendances, Out Of Hours (OOH) contacts and hospital admissions during the last 6 months at baseline and 6 months for MISSION RAAC and primary care patients. | 6 months previous | 
| ED attendances at baseline | Emergency Department (ED) attendances at baseline for MISSION RAAC and primary care patients. | Baseline | 
| OOH contacts at baseline | Out Of Hours (OOH) contacts at baseline for MISSION RAAC and primary care patients. | Baseline | 
| Hospital admissions at baseline | Hospital admissions at baseline for MISSION RAAC and primary care patients. | Baseline | 
| ED attendances at 6 months. | Emergency Department (ED) attendances at 6 months for MISSION RAAC and primary care patients. | 6 months | 
| Out Of Hours (OOH) contacts at 6 months | Out Of Hours (OOH) contacts at 6 months for MISSION RAAC and primary care patients. | 6 months | 
| Hospital admissions during at 6 months | Hospital admissions during at 6 months for MISSION RAAC and primary care patients. | 6 months | 
| Inhaled steroid doses and usage | Inhaled steroid doses and usage for MISSION RAAC and primary care patients. | 6 months | 
| sensitivity and specificity of the Primary Care Information Services (PRIMIS) Asthma Audit Tool | The sensitivity and specificity of the PRIMIS Asthma Audit Tool in identifying the patients compared to gold standard specialist assessment and interrogation of primary care records for MISSION RAAC and primary care patients. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Severe Asthma, Asthma, Specialised Asthma Care, Asthma Care