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Completed

NCT Number: NCT02509130

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

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital

Portsmouth, Hampshire, PO6 3LY, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Asthma control as measured by exacerbation frequency for all patients

    Time frame: 6 months

    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

Secondary outcomes

  1. Short acting bronchodilator (SABA) use

    Time frame: 6 months

    Short acting bronchodilator (SABA) use measured by number of inhalers prescribed in 6 months pre and post MISSION SAAC, RAAC or outpatient clinic.

  2. Exacerbation frequency

    Time frame: 6 months

    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.

  3. Health care usage costs for asthma and number of contacts

    Time frame: 6 months

    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.

  4. Assessment of co-morbidity

    Time frame: 6 months

    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

  5. Assessment of inhaler technique and recommendations for inhaler devices.

    Time frame: 6 months

    Assessment of inhaler technique and recommendations for inhaler devices for MISSION SAAC patients and outpatient severe asthma clinic patients

  6. Smoking cessation advice.

    Time frame: 6 months

    Smoking cessation advice for MISSION SAAC patients and outpatient severe asthma clinic patients

  7. Investigations performed in secondary care

    Time frame: 6 months

    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

  8. Time from GP referral to 1st clinic visit

    Time frame: 6 months

    Time from GP referral to 1st clinic visit in secondary care for MISSION SAAC patients and outpatient severe asthma clinic patients

  9. Time between 1st and 2nd visit

    Time frame: 6 months

    Time between 1st and 2nd visit in secondary care for MISSION SAAC patients and outpatient severe asthma clinic patients

  10. Time to appointment with other specialists

    Time frame: 6 months

    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

  11. Fractional Exhaled Nitric Oxide (FeNO) Assessment

    Time frame: 6 months

    Assessment of eosinophilic airways inflammation by FeNO for MISSION SAAC patients and outpatient severe asthma clinic patients

  12. Frequency of non-attendance

    Time frame: 6 months

    The frequency of non-attendance at clinic for MISSION SAAC patients and outpatient severe asthma clinic patients

  13. Severity of co-morbidities

    Time frame: 6 months

    Severity of co-morbidities for MISSION RAAC patients

  14. Frequency of co-morbidities

    Time frame: 6 months

    Frequency of co-morbidities for MISSION RAAC patients

  15. Frequency & type of allergy

    Time frame: 6 months

    Frequency & type of allergy for MISSION RAAC patients

  16. Measurement of exhaled nitric oxide

    Time frame: 6 months

    Measurement of exhaled nitric oxide for MISSION RAAC patients

  17. Measurement & variation of lung function (Single

    Time frame: 6 months

    Composite measurement & variation of lung function for MISSION RAAC patients

  18. Frequency and type of additional asthma control medication.

    Time frame: 6 months

    Frequency and type of additional asthma control medication for MISSION RAAC patients

  19. Quality of life

    Time frame: 6 months

    Quality of life as assessed by the Asthma Quality of Life Questionnaire (AQLQ).

  20. Disease control

    Time frame: 6 months

    Disease control as assessed by the Asthma Control Questionnaire (ACQ)

  21. Number of Forced Expiratory Volume at one second (FEV1) / Forced Vital Capacity (FVC) measurements

    Time frame: 6 months

    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

  22. Prescription of SABA's

    Time frame: 6 months previous

    Prescription of Short Acting Bronchodilators (SABAs) during last 6 months at baseline and 6 months for MISSION RAAC and primary care patients.

  23. Prescription of SABA's

    Time frame: Baseline

    Prescription of Short Acting Bronchodilators (SABAs) during last 6 months at baseline and 6 months for MISSION RAAC and primary care patients.

  24. Prescription of SABA's

    Time frame: 6 months

    Prescription of Short Acting Bronchodilators (SABAs) during last 6 months at baseline and 6 months for MISSION RAAC and primary care patients.

  25. Exacerbation rates

    Time frame: 6 months previous

    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.

  26. Exacerbation rates

    Time frame: Baseline

    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.

  27. Exacerbation rates

    Time frame: 6 months

    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.

  28. ED attendances during the last 6 months

    Time frame: 6 months previous

    Emergency Department (ED) attendances during the last 6 months at baseline and 6 months for MISSION RAAC and primary care patients.

  29. Out Of Hours (OOH) contacts during the last 6 months

    Time frame: 6 months previous

    Out Of Hours (OOH) contacts during the last 6 months at baseline and 6 months for MISSION RAAC and primary care patients.

  30. Hospital admissions during the last 6 months

    Time frame: 6 months previous

    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.

  31. ED attendances at baseline

    Time frame: Baseline

    Emergency Department (ED) attendances at baseline for MISSION RAAC and primary care patients.

  32. OOH contacts at baseline

    Time frame: Baseline

    Out Of Hours (OOH) contacts at baseline for MISSION RAAC and primary care patients.

  33. Hospital admissions at baseline

    Time frame: Baseline

    Hospital admissions at baseline for MISSION RAAC and primary care patients.

  34. ED attendances at 6 months.

    Time frame: 6 months

    Emergency Department (ED) attendances at 6 months for MISSION RAAC and primary care patients.

  35. Out Of Hours (OOH) contacts at 6 months

    Time frame: 6 months

    Out Of Hours (OOH) contacts at 6 months for MISSION RAAC and primary care patients.

  36. Hospital admissions during at 6 months

    Time frame: 6 months

    Hospital admissions during at 6 months for MISSION RAAC and primary care patients.

  37. Inhaled steroid doses and usage

    Time frame: 6 months

    Inhaled steroid doses and usage for MISSION RAAC and primary care patients.

  38. sensitivity and specificity of the Primary Care Information Services (PRIMIS) Asthma Audit Tool

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Portsmouth Hospitals NHS Trust

Other Gov

Collaborators

  • University of Portsmouth

Registry information

Official study 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.

Acronym: MISSION

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 27, 2015
Registry last updated
Sep 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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