Clinical trial NCT02534766: MISSION COPD - Modern Innovative SolutionS in Improving Outcomes iN COPD
Official title: MISSION COPD - Modern Innovative SolutionS in Improving Outcomes iN - COPD - A Comparison of Clinical Outcomes Before and After the MISSION Clinic.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Portsmouth Hospitals NHS Trust
Sponsor class: OTHER_GOV
Collaborators: name: Pfizer
First posted: 2015-08-28
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: COPD control measured by number of exacerbations treated with steroids and or antibiotics for ≥3 days
timeFrame: 6 months previous
measure: COPD control measured by number of exacerbations treated with steroids and or antibiotics for ≥3 days
timeFrame: 6 months
measure: Number of exacerbations of COPD that require hospital admission and treatment
timeFrame: 6 months previous
measure: Number of exacerbations of COPD that require hospital admission and treatment
timeFrame: 6 months
Secondary outcomes:
measure: COPD Assessment Test (CAT) Score
timeFrame: baseline
measure: COPD Assessment Test (CAT) Score
timeFrame: 3 months
measure: COPD Assessment Test (CAT) Score
timeFrame: 6 months
measure: St George's Respiratory Questionnaire (SGRQ)
timeFrame: baseline
measure: St George's Respiratory Questionnaire (SGRQ)
timeFrame: 3 months
measure: St George's Respiratory Questionnaire (SGRQ)
timeFrame: 6 months
measure: Number of non elective GP visits for COPD
timeFrame: 6 month previous
measure: Number of non elective GP visits for COPD
timeFrame: 6 months
measure: Number of hospital admissions for COPD
timeFrame: 6 month previous
measure: Number of hospital admissions for COPD
timeFrame: 6 months
measure: Number of Emergency Department contacts for COPD
timeFrame: 6 month previous
measure: Number of Emergency Department contacts for COPD
timeFrame: 6 months
measure: Number of out of hour (OOH) attendances/contacts for COPD
timeFrame: 6 month previous
measure: Number of out of hour (OOH) attendances/contacts for COPD
timeFrame: 6 months
measure: Global initiative in chronic Obstructive Lung Disease (GOLD) score
timeFrame: Baseline
measure: Measurement and variation of lung function.
timeFrame: Baseline
measure: Assessment of eosinophilic airways inflammation
timeFrame: Baseline
measure: COPD controller medication
timeFrame: 6 months previous
measure: COPD controller medication
timeFrame: 6 months
measure: Number of antibiotic courses without prednisolone for lower respiratory tract infections
timeFrame: 6 months previous
measure: Number of antibiotic courses without prednisolone for lower respiratory tract infections
timeFrame: 6 months
measure: Short acting bronchodilator (SABA) use
timeFrame: 6 months previous
measure: Short acting bronchodilator (SABA) use
timeFrame: 6 months
measure: Frequency and severity of co-morbidities
timeFrame: Baseline
measure: Medication adherence
timeFrame: Baseline
measure: Medication adherence
timeFrame: 3 months
measure: Medication adherence
timeFrame: 6 months
measure: Patient activation measure
timeFrame: Baseline
measure: Patient activation measure
timeFrame: 3 months
measure: Patient activation measure
timeFrame: 6 months
measure: Investigations performed
timeFrame: Baseline
measure: Hospital Anxiety and Depression Scale (HADS) score
timeFrame: Baseline
measure: Hospital Anxiety and Depression Scale (HADS) score
timeFrame: 6 months
measure: Gastroesophageal Reflux Disease Questionnaire (GERDQ) score
timeFrame: baseline
measure: Gastroesophageal Reflux Disease Questionnaire (GERDQ) score
timeFrame: 6 months
measure: Assessment of inhaler technique and recommendations for inhaler devices.
timeFrame: Baseline
measure: Smoking cessation advice
timeFrame: Baseline
measure: The frequency of non-attendance at clinic
timeFrame: Baseline
Other outcomes:
Locations:
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital
state: Hampshire
Study officials:
affiliation: Portsmouth Hospitals NHS Trust
name: Professor Anoop J Chauhan
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.