NCT02509130

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 13, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 27, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

September 27, 2016

Status Verified

September 1, 2016

Enrollment Period

9 months

First QC Date

July 13, 2015

Last Update Submit

September 26, 2016

Conditions

Keywords

Severe AsthmaAsthmaSpecialised Asthma CareAsthma Care

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (38)

  • 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

  • +33 more secondary outcomes

Study Arms (4)

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.

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.

Asthma Outpatients

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

Healthcare Professionals

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • The patient is unable or unwilling to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital

Portsmouth, Hampshire, PO6 3LY, United Kingdom

Location

Related Publications (4)

  • 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.

    PMID: 9283852BACKGROUND
  • 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.

    PMID: 9283853BACKGROUND
  • 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.

    PMID: 20450084BACKGROUND
  • 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.

    PMID: 10673494BACKGROUND

Related Links

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Professor Anoop J Chauhan

    Portsmouth Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2015

First Posted

July 27, 2015

Study Start

June 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

September 27, 2016

Record last verified: 2016-09

Locations