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

NIHR

UK Clinical Trials, clinical research uk

Primary Trial ID Number

NCT02509130

Summary
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.
Research Details
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.
Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Retrospective
Study Type
Observational
Intervention
Sorry, this information is not available
Intervention Type
See Interventions above
Primary Outcome Measures
Asthma control as measured by exacerbation frequency for all patients; 6 months
Secondary Outcome Measures
Short acting bronchodilator (SABA) use; 6 months; Exacerbation frequency; 6 months; Health care usage costs for asthma and number of contacts; 6 months; Assessment of co-morbidity; 6 months; Assessment of inhaler technique and recommendations for inhaler devices.; 6 months; Smoking cessation advice.; 6 months; Investigations performed in secondary care; 6 months; Time from GP referral to 1st clinic visit; 6 months; Time between 1st and 2nd visit; 6 months; Time to appointment with other specialists; 6 months; Fractional Exhaled Nitric Oxide (FeNO) Assessment; 6 months; Frequency of non-attendance; 6 months; Severity of co-morbidities; 6 months; Frequency of co-morbidities; 6 months; Frequency & type of allergy; 6 months; Measurement of exhaled nitric oxide; 6 months; Measurement & variation of lung function (Single; 6 months; Frequency and type of additional asthma control medication.; 6 months; Quality of life; 6 months; Disease control; 6 months; Number of Forced Expiratory Volume at one second (FEV1) / Forced Vital Capacity (FVC) measurements; 6 months; Prescription of SABA’s; 6 months previous; Prescription of SABA’s; Baseline; Prescription of SABA’s; 6 months; Exacerbation rates; 6 months previous; Exacerbation rates; Baseline; Exacerbation rates; 6 months; ED attendances during the last 6 months; 6 months previous; Out Of Hours (OOH) contacts during the last 6 months; 6 months previous; Hospital admissions during the last 6 months; 6 months previous; ED attendances at baseline; Baseline; OOH contacts at baseline; Baseline; Hospital admissions at baseline; Baseline; ED attendances at 6 months.; 6 months; Out Of Hours (OOH) contacts at 6 months; 6 months; Hospital admissions during at 6 months; 6 months; Inhaled steroid doses and usage; 6 months; sensitivity and specificity of the Primary Care Information Services (PRIMIS) Asthma Audit Tool; 6 months

Gender
Both
Age Range
18 Years – N/A
Who Can Participate
Sorry, this information is not available
Number of Participants
216
Participant Inclusion Criteria
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

Trial Location(s)
Portsmouth Hospitals NHS Trust
Portsmouth
PO6 3LY
Trial Contact(s)
Primary Trial Contact
Dr Claire Roberts
claire.roberts2@porthosp.nhs.uk
4108 +442392 286000
Other Trial Contacts
Professor Anoop J Chauhan
anoop.chauhan@porthosp.nhs.uk
3360 +442393 286000
Countries Recruiting
United Kingdom

Scientific Title
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.
EudraCT Number
Not available for this trial
Funder(s)
University of Portsmouth
Other Study ID Numbers
PHT/2015/15
Sponsor(s)
Portsmouth Hospitals NHS Trust

To apply for this job please visit the following URL: http://www.ukctg.nihr.ac.uk/trials/trial-details/trial-details?trialId=30423 →