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

NCT ID: NCT02509130

Last Updated: 2016-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

92 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-03-31

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.

Conditions

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Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients who attended RAAC/SAAC.

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.

No interventions assigned to this group

Patients eligible for RAAC, but DNA'd

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.

No interventions assigned to this group

Asthma Outpatients

Patients who are attending outpatient clinics as new referrals will be approached to participate in the quantitative part of the study.

No interventions assigned to this group

Healthcare Professionals

Healthcare professionals who performed the MISSION RAAC or SAAC will be approached for qualitative interview part of the study only.

No interventions assigned to this group

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Portsmouth

OTHER

Sponsor Role collaborator

Portsmouth Hospitals NHS Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Professor Anoop J Chauhan

Role: PRINCIPAL_INVESTIGATOR

Portsmouth Hospitals NHS Trust

Locations

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Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital

Portsmouth, Hampshire, United Kingdom

Site Status

Countries

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United Kingdom

References

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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. doi: 10.1093/fampra/14.4.307.

Reference Type BACKGROUND
PMID: 9283852 (View on PubMed)

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. doi: 10.1093/fampra/14.4.313.

Reference Type BACKGROUND
PMID: 9283853 (View on PubMed)

Bulpitt H, Martin PJ. Who am I and what am I doing? Becoming a qualitative research interviewer. Nurse Res. 2010;17(3):7-16. doi: 10.7748/nr2010.04.17.3.7.c7741.

Reference Type BACKGROUND
PMID: 20450084 (View on PubMed)

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. doi: 10.1093/fampra/17.1.71.

Reference Type BACKGROUND
PMID: 10673494 (View on PubMed)

Related Links

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http://www.gov.uk/government/publications/an-outcomes-strategy-for-people-with-chronic-obstructive-pulmonary-disease-copd-and-asthma-in-england

Department of Health - An outcomes strategy for people with chronic obstructive pulmonary disease (COPD) and asthma in England

Other Identifiers

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PHT/2015/15

Identifier Type: -

Identifier Source: org_study_id

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