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Completed

NCT Number: NCT02534766

MISSION COPD - Modern Innovative SolutionS in Improving Outcomes iN COPD

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.

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Key information

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

The purpose of the study is to evaluate in detail the clinical and health economic outcomes from the MISSION COPD project. MISSION COPD is a quality improvement project funded by the Health Foundation, Foundation with additional funding from Pfizer, to trial an innovative way of finding and assessing patients with COPD and also case finding new diagnoses of COPD.

MISSION-COPD will allow swift early specialist multi-disciplinary interventions in primary care to diagnose and treat those at greatest risk, consistent with the NHS England '5-year Forward View' calling for removal of traditional primary and secondary care barriers. MISSION COPD will target COPD patients with risk factors for exacerbations and deteriorating lung function as well potential new diagnoses of COPD.

The aim of the study is to review the MISSION clinic model outcomes as well as performing qualitative interviews with patients who attended and staff who took part in the project.

Up to 150 patients who attend the MISSION COPD clinic will be recruited along with approximately 20 health care professionals. The number of patients has been decided as the number that can be seen for the project in the MISSION COPD project time and budget.

Participants will be either:

  • 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
  • Health care professionals who attend the clinic in a clinical capacity.

Retrospective quantitative analysis of the data collected during the MISSION clinics will be analysed looking for COPD phenotypes and contributing co-morbidities. The data collected at the initial visit and 3 and 6 month follow up questionnaires will be analysed looking for improvement in COPD control and quality of life following the patients' attendance at MISSION clinics.

A self completion questionnaire will be filled in after the clinic by participants in the research study to assess their views on the clinic and where they would like changes to be made. A questionnaire will also be given to health care professionals to seek their views on the clinic.

Qualitative interviews will be conducted with a sample of participants, willing to take part, to explore the experiences and acceptability of the participants and health care professionals. The interviews with health care professionals will explore their thoughts on MISSION and its strengths and weaknesses as well as any suggestions for improvement.

This research is important as it will provide evidence to support the use of the MISSION clinic model for patients with COPD. It will also give us more information on the patient with COPD and any medical conditions related to their COPD so we can adapt our service to meet their needs.

The telephone and group interviews will help us understand what we are doing right and what we are doing wrong with COPD care.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

- Patients:

  • 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.

Exclusion criteria

- Patients:

  • The patient is unable or unwilling to give consent

Inclusion criteria

- Health Care Professionals

  • 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.

Exclusion criteria

- Health Care Professionals

  • The health care professional is unable or unwilling to give consent

Treatment and study plan

Primary outcomes

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

    Time frame: 6 months previous

    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.

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

    Time frame: 6 months

    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.

  3. Number of exacerbations of COPD that require hospital admission and treatment

    Time frame: 6 months previous

    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

  4. Number of exacerbations of COPD that require hospital admission and treatment

    Time frame: 6 months

    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

Secondary outcomes

  1. COPD Assessment Test (CAT) Score

    Time frame: baseline

    patients will complete the CAT questionnaire to assess COPD control

  2. COPD Assessment Test (CAT) Score

    Time frame: 3 months

    patients will complete the CAT questionnaire to assess COPD control

  3. COPD Assessment Test (CAT) Score

    Time frame: 6 months

    patients will complete the CAT questionnaire to assess COPD control

  4. St George's Respiratory Questionnaire (SGRQ)

    Time frame: baseline

  5. St George's Respiratory Questionnaire (SGRQ)

    Time frame: 3 months

  6. St George's Respiratory Questionnaire (SGRQ)

    Time frame: 6 months

  7. Number of non elective GP visits for COPD

    Time frame: 6 month previous

    Number of non elective GP visits for COPD in the 6 months pre MISSION

  8. Number of non elective GP visits for COPD

    Time frame: 6 months

    Number of non elective GP visits for COPD in the 6 months post MISSION

  9. Number of hospital admissions for COPD

    Time frame: 6 month previous

    Number of hospital admissions for COPD in the 6 months pre MISSION

  10. Number of hospital admissions for COPD

    Time frame: 6 months

    Number of hospital admissions for COPD in the 6 months post MISSION

  11. Number of Emergency Department contacts for COPD

    Time frame: 6 month previous

    Number of Emergency Department contacts for COPD in the 6 months pre MISSION

  12. Number of Emergency Department contacts for COPD

    Time frame: 6 months

    Number of Emergency Department contacts for COPD in the 6 months post MISSION

  13. Number of out of hour (OOH) attendances/contacts for COPD

    Time frame: 6 month previous

    Number of out of hour attendances (OOH) contacts for COPD in the 6 months pre MISSION

  14. Number of out of hour (OOH) attendances/contacts for COPD

    Time frame: 6 months

    Number of out of hour attendances (OOH) contacts for COPD in the 6 months post MISSION

  15. Global initiative in chronic Obstructive Lung Disease (GOLD) score

    Time frame: Baseline

    To assess the severity of COPD by GOLD and BTS stage in the MISSION clinics

  16. Measurement and variation of lung function.

    Time frame: Baseline

  17. Assessment of eosinophilic airways inflammation

    Time frame: Baseline

    Assessment of eosinophilic airways inflammation by Fractional Exhaled Nitric Oxide (FeNO) Assessment.

  18. COPD controller medication

    Time frame: 6 months previous

    COPD controller medication in 6 months pre MISSION.

  19. COPD controller medication

    Time frame: 6 months

    COPD controller medication in 6 months post MISSION.

  20. Number of antibiotic courses without prednisolone for lower respiratory tract infections

    Time frame: 6 months previous

    Number of antibiotic courses without prednisolone for lower respiratory tract infections in 6 months pre MISSION

  21. Number of antibiotic courses without prednisolone for lower respiratory tract infections

    Time frame: 6 months

    Number of antibiotic courses without prednisolone for lower respiratory tract infections in 6 months post MISSION

  22. Short acting bronchodilator (SABA) use

    Time frame: 6 months previous

    Short acting bronchodilator (SABA) use measured by number of inhalers prescribed in 6 months pre MISSION.

  23. Short acting bronchodilator (SABA) use

    Time frame: 6 months

    Short acting bronchodilator (SABA) use measured by number of inhalers prescribed in 6 months post MISSION.

  24. Frequency and severity of co-morbidities

    Time frame: Baseline

    Frequency and severity of co morbidities including anxiety and depression, dysfunctional breathing, gastro oesophageal reflux and obstructive sleep apnoea in all patients.

  25. Medication adherence

    Time frame: Baseline

    Medication adherence will be measured at baseline

  26. Medication adherence

    Time frame: 3 months

    Medication adherence will be measured at 3 months

  27. Medication adherence

    Time frame: 6 months

    Medication adherence will be measured at 6 months

  28. Patient activation measure

    Time frame: Baseline

    Patients will complete the patient activation measure questionnaire at Baseline

  29. Patient activation measure

    Time frame: 3 months

    Patients will complete the patient activation measure questionnaire at 3 months

  30. Patient activation measure

    Time frame: 6 months

    Patients will complete the patient activation measure questionnaire at 6 months

  31. Investigations performed

    Time frame: Baseline

    Investigations performed at the MISSION COPD clinics (e.g. sputum induction, High-Resolution Computed Tomography (HRCT) chest).

  32. Hospital Anxiety and Depression Scale (HADS) score

    Time frame: Baseline

    HADS scores at baseline for patients attending the MISSION clinics

  33. Hospital Anxiety and Depression Scale (HADS) score

    Time frame: 6 months

    HADS scores at 6 months for patients attending the MISSION clinics

  34. Gastroesophageal Reflux Disease Questionnaire (GERDQ) score

    Time frame: baseline

    GERDQ scores at baseline for patients attending the Severe COPD Assessment Clinic (SCAC)

  35. Gastroesophageal Reflux Disease Questionnaire (GERDQ) score

    Time frame: 6 months

    GERDQ scores at 6 months for patients attending the Severe COPD Assessment Clinic (SCAC)

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

    Time frame: Baseline

  37. Smoking cessation advice

    Time frame: Baseline

  38. The frequency of non-attendance at clinic

    Time frame: Baseline

    The frequency of non-attendance at the MISSION clinic

Sponsors and collaborators

Lead sponsor

Portsmouth Hospitals NHS Trust

Other Gov

Collaborators

  • Pfizer

Registry information

Official study title

MISSION COPD - Modern Innovative SolutionS in Improving Outcomes iN - COPD - A Comparison of Clinical Outcomes Before and After the MISSION Clinic.

Acronym: MISSION-COPD

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 28, 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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