Clinical trial NCT02509130: MISSION Severe Asthma Modern Innovative Solutions to Improve Outcomes in Severe Asthma.
Official 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Severe Asthma
Asthma
Specialised Asthma Care
Asthma Care
Lead sponsor: Portsmouth Hospitals NHS Trust
Sponsor class: OTHER_GOV
Collaborators: name: University of Portsmouth
First posted: 2015-07-27
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with uncontrolled or potentially severe asthma identified from GP records by the MISSION team and new referrals to an asthma specialist clinic at Queen Alexandra Hospital between May and August 2014.

Study participants for qualitative interview will be recruited from patients who attended MISSION SAAC days and staff who attended MISSION RAAC or SAAC days.

Brief 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Asthma control as measured by exacerbation frequency for all patients
timeFrame: 6 months
Secondary outcomes:
measure: Short acting bronchodilator (SABA) use
timeFrame: 6 months
measure: Exacerbation frequency
timeFrame: 6 months
measure: Health care usage costs for asthma and number of contacts
timeFrame: 6 months
measure: Assessment of co-morbidity
timeFrame: 6 months
measure: Assessment of inhaler technique and recommendations for inhaler devices.
timeFrame: 6 months
measure: Smoking cessation advice.
timeFrame: 6 months
measure: Investigations performed in secondary care
timeFrame: 6 months
measure: Time from GP referral to 1st clinic visit
timeFrame: 6 months
measure: Time between 1st and 2nd visit
timeFrame: 6 months
measure: Time to appointment with other specialists
timeFrame: 6 months
measure: Fractional Exhaled Nitric Oxide (FeNO) Assessment
timeFrame: 6 months
measure: Frequency of non-attendance
timeFrame: 6 months
measure: Severity of co-morbidities
timeFrame: 6 months
measure: Frequency of co-morbidities
timeFrame: 6 months
measure: Frequency & type of allergy
timeFrame: 6 months
measure: Measurement of exhaled nitric oxide
timeFrame: 6 months
measure: Measurement & variation of lung function (Single
timeFrame: 6 months
measure: Frequency and type of additional asthma control medication.
timeFrame: 6 months
measure: Quality of life
timeFrame: 6 months
measure: Disease control
timeFrame: 6 months
measure: Number of Forced Expiratory Volume at one second (FEV1) / Forced Vital Capacity (FVC) measurements
timeFrame: 6 months
measure: Prescription of SABA's
timeFrame: 6 months previous
measure: Prescription of SABA's
timeFrame: Baseline
measure: Prescription of SABA's
timeFrame: 6 months
measure: Exacerbation rates
timeFrame: 6 months previous
measure: Exacerbation rates
timeFrame: Baseline
measure: Exacerbation rates
timeFrame: 6 months
measure: ED attendances during the last 6 months
timeFrame: 6 months previous
measure: Out Of Hours (OOH) contacts during the last 6 months
timeFrame: 6 months previous
measure: Hospital admissions during the last 6 months
timeFrame: 6 months previous
measure: ED attendances at baseline
timeFrame: Baseline
measure: OOH contacts at baseline
timeFrame: Baseline
measure: Hospital admissions at baseline
timeFrame: Baseline
measure: ED attendances at 6 months.
timeFrame: 6 months
measure: Out Of Hours (OOH) contacts at 6 months
timeFrame: 6 months
measure: Hospital admissions during at 6 months
timeFrame: 6 months
measure: Inhaled steroid doses and usage
timeFrame: 6 months
measure: sensitivity and specificity of the Primary Care Information Services (PRIMIS) Asthma Audit Tool
timeFrame: 6 months
Other outcomes:
Locations:
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital
state: Hampshire
Study officials:
affiliation: Portsmouth Hospitals NHS Trust
name: Professor Anoop J Chauhan
role: PRINCIPAL_INVESTIGATOR
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