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MISSION COPD - Modern Innovative SolutionS in Improving Outcomes iN COPD

Completed
Conditions
Pulmonary Disease, Chronic Obstructive
Registration Number
NCT02534766
Lead Sponsor
Portsmouth Hospitals NHS Trust
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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
114
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
COPD control measured by number of exacerbations treated with steroids and or antibiotics for ≥3 days6 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.

Number of exacerbations of COPD that require hospital admission and treatment6 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 Outcome Measures
NameTimeMethod
Assessment of inhaler technique and recommendations for inhaler devices.Baseline
Measurement and variation of lung function.Baseline
St George's Respiratory Questionnaire (SGRQ)6 months
Assessment of eosinophilic airways inflammationBaseline

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

Frequency and severity of co-morbiditiesBaseline

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

Medication adherence6 months

Medication adherence will be measured at 6 months

Gastroesophageal Reflux Disease Questionnaire (GERDQ) score6 months

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

COPD Assessment Test (CAT) Score6 months

patients will complete the CAT questionnaire to assess COPD control

Number of non elective GP visits for COPD6 months

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

Number of hospital admissions for COPD6 months

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

Number of Emergency Department contacts for COPD6 months

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

Number of out of hour (OOH) attendances/contacts for COPD6 months

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

Short acting bronchodilator (SABA) use6 months

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

Smoking cessation adviceBaseline
COPD controller medication6 months

COPD controller medication in 6 months post MISSION.

Number of antibiotic courses without prednisolone for lower respiratory tract infections6 months

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

Investigations performedBaseline

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

Hospital Anxiety and Depression Scale (HADS) score6 months

HADS scores at 6 months for patients attending the MISSION clinics

Global initiative in chronic Obstructive Lung Disease (GOLD) scoreBaseline

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

Patient activation measure6 months

Patients will complete the patient activation measure questionnaire at 6 months

The frequency of non-attendance at clinicBaseline

The frequency of non-attendance at the MISSION clinic

Trial Locations

Locations (1)

Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital

🇬🇧

Portsmouth, Hampshire, United Kingdom

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