NCT02534766

Brief Summary

MISSION is a new and novel way of delivering highly specialised Chronic Obstructive Pulmonary Disease (COPD) care and has the potential to change the way COPD care across the UK is delivered as well as services for other long term health conditions. The MISSION model has been piloted in asthma which is the subject of an ongoing research study. This is the first model of this type in COPD and the current research study aims to evaluate the outcomes of the project. 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 clinic using retrospective data analysis and prospective qualitative interview. The study will be conducted at Portsmouth Hospitals NHS Trust and will recruit patients who attend MISSION COPD clinics as well as staff who attended MISSION clinics in a professional capacity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 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

First Submitted

Initial submission to the registry

August 25, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 28, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

September 27, 2016

Status Verified

September 1, 2016

Enrollment Period

11 months

First QC Date

August 25, 2015

Last Update Submit

September 26, 2016

Conditions

Outcome Measures

Primary Outcomes (4)

  • COPD control measured by number of exacerbations treated with steroids and or antibiotics for ≥3 days

    To assess whether the number COPD exacerbations (prednisolone or equivalent ≥30 mg for \>3 days or antibiotics for \>3 days) improves in MISSION patients in the 6 months after the clinic compared with the 6 months before.

    6 months previous

  • COPD control measured by number of exacerbations treated with steroids and or antibiotics for ≥3 days

    To assess whether the number COPD exacerbations (prednisolone or equivalent ≥30 mg for \>3 days or antibiotics for \>3 days) improves in MISSION patients in the 6 months after the clinic compared with the 6 months before.

    6 months

  • Number of exacerbations of COPD that require hospital admission and treatment

    Number of exacerbations of COPD that require admission to hospital for treatment to assess whether hospital admissions change in the 6 months after the MISSION clinic

    6 months previous

  • Number of exacerbations of COPD that require hospital admission and treatment

    Number of exacerbations of COPD that require admission to hospital for treatment to assess whether hospital admissions change in the 6 months after the MISSION clinic

    6 months

Secondary Outcomes (38)

  • COPD Assessment Test (CAT) Score

    baseline

  • COPD Assessment Test (CAT) Score

    3 months

  • COPD Assessment Test (CAT) Score

    6 months

  • St George's Respiratory Questionnaire (SGRQ)

    baseline

  • St George's Respiratory Questionnaire (SGRQ)

    3 months

  • +33 more secondary outcomes

Study Arms (2)

Patients who attended the MISSION COPD clinics

COPD patients who attended the MISSION COPD clinics, identified as having uncontrolled or potentially severe COPD or unrecognised COPD from GP records by the MISSION clinical team

Health Care Professionals

Health Care Professionals who attended the MISSION COPD clinics in a professional/ clinical capacity.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will be patients who attend MISSION COPD clinics, identified as having uncontrolled or potentially severe COPD or unrecognised COPD from GP records by the MISSION clinical team or health care professionals who attend the clinic in a clinical capacity.

You may qualify if:

  • Male of Female, aged 18 years or above.
  • Attended the MISSION clinic as a patient.
  • 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
  • Male or Female, aged 18 or above.
  • Attended the MISSION clinic as a health care professional
  • Participant is willing and able to give informed consent for participation in the study.
  • \- The health care professional 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 (2)

  • Kruis AL, Smidt N, Assendelft WJ, Gussekloo J, Boland MR, Rutten-van Molken M, Chavannes NH. Integrated disease management interventions for patients with chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2013 Oct 10;(10):CD009437. doi: 10.1002/14651858.CD009437.pub2.

    PMID: 24108523BACKGROUND
  • Wilkinson T, North M, Bourne SC. Reducing hospital admissions and improving the diagnosis of COPD in Southampton City: methods and results of a 12-month service improvement project. NPJ Prim Care Respir Med. 2014 Aug 21;24(0):14035. doi: 10.1038/npjpcrm.2014.35.

    PMID: 25141877BACKGROUND

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

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

August 25, 2015

First Posted

August 28, 2015

Study Start

September 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

September 27, 2016

Record last verified: 2016-09

Locations