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

Asthma Clinical Trial

— MISSION  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02509130
• Other study ID #: PHT/2015/15
• Status: Completed
• Phase: N/A
• First received: July 13, 2015
• Last updated: September 26, 2016
• Start date: June 2015
• Est. completion date: March 2016

Study information

• Verified date: September 2016
• Source: Portsmouth Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
United Kingdom	Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital	Portsmouth	Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Portsmouth Hospitals NHS Trust	University of Portsmouth

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

Bulpitt H, Martin PJ. Who am I and what am I doing? Becoming a qualitative research interviewer. Nurse Res. 2010;17(3):7-16. — View Citation

Hoddinott P, Pill R. A review of recently published qualitative research in general practice. More methodological questions than answers? Fam Pract. 1997 Aug;14(4):313-9. Review. — View Citation

Hoddinott P, Pill R. Qualitative research interviewing by general practitioners. A personal view of the opportunities and pitfalls. Fam Pract. 1997 Aug;14(4):307-12. — View Citation

Richards H, Emslie C. The 'doctor' or the 'girl from the University'? Considering the influence of professional roles on qualitative interviewing. Fam Pract. 2000 Feb;17(1):71-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Smoking cessation advice.	Smoking cessation advice for MISSION SAAC patients and outpatient severe asthma clinic patients	6 months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Frequency of non-attendance	The frequency of non-attendance at clinic for MISSION SAAC patients and outpatient severe asthma clinic patients	6 months	No
Secondary	Severity of co-morbidities	Severity of co-morbidities for MISSION RAAC patients	6 months	No
Secondary	Frequency of co-morbidities	Frequency of co-morbidities for MISSION RAAC patients	6 months	No
Secondary	Frequency & type of allergy	Frequency & type of allergy for MISSION RAAC patients	6 months	No
Secondary	Measurement of exhaled nitric oxide	Measurement of exhaled nitric oxide for MISSION RAAC patients	6 months	No
Secondary	Measurement & variation of lung function (Single	Composite measurement & variation of lung function for MISSION RAAC patients	6 months	No
Secondary	Frequency and type of additional asthma control medication.	Frequency and type of additional asthma control medication for MISSION RAAC patients	6 months	No
Secondary	Quality of life	Quality of life as assessed by the Asthma Quality of Life Questionnaire (AQLQ).	6 months	No
Secondary	Disease control	Disease control as assessed by the Asthma Control Questionnaire (ACQ)	6 months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	ED attendances at baseline	Emergency Department (ED) attendances at baseline for MISSION RAAC and primary care patients.	Baseline	No
Secondary	OOH contacts at baseline	Out Of Hours (OOH) contacts at baseline for MISSION RAAC and primary care patients.	Baseline	No
Secondary	Hospital admissions at baseline	Hospital admissions at baseline for MISSION RAAC and primary care patients.	Baseline	No
Secondary	ED attendances at 6 months.	Emergency Department (ED) attendances at 6 months for MISSION RAAC and primary care patients.	6 months	No
Secondary	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	No
Secondary	Hospital admissions during at 6 months	Hospital admissions during at 6 months for MISSION RAAC and primary care patients.	6 months	No
Secondary	Inhaled steroid doses and usage	Inhaled steroid doses and usage for MISSION RAAC and primary care patients.	6 months	No
Secondary	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	No

External Links

•   Asthma UK
•   Department of Health - An outcomes strategy for people with chronic obstructive pulmonary disease (COPD) and asthma in England
•   Why asthma still kills - The National Review of Asthma Deaths (NRAD)