MISSION COPD - Modern Innovative SolutionS in Improving Outcomes iN COPD

Pulmonary Disease, Chronic Obstructive Clinical Trial

— MISSION-COPD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02534766
• Other study ID #: PHT/2015/71
• Status: Completed
• Phase: N/A
• First received: August 25, 2015
• Last updated: September 26, 2016
• Start date: September 2015
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: Portsmouth Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
United Kingdom	Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital	Portsmouth	Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Portsmouth Hospitals NHS Trust	Pfizer

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

Kruis AL, Smidt N, Assendelft WJ, Gussekloo J, Boland MR, Rutten-van Mölken 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. Review. — View 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;24:14035. doi: 10.1038/npjpcrm.2014.35. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	COPD Assessment Test (CAT) Score	patients will complete the CAT questionnaire to assess COPD control	baseline	No
Secondary	COPD Assessment Test (CAT) Score	patients will complete the CAT questionnaire to assess COPD control	3 months	No
Secondary	COPD Assessment Test (CAT) Score	patients will complete the CAT questionnaire to assess COPD control	6 months	No
Secondary	St George's Respiratory Questionnaire (SGRQ)		baseline	No
Secondary	St George's Respiratory Questionnaire (SGRQ)		3 months	No
Secondary	St George's Respiratory Questionnaire (SGRQ)		6 months	No
Secondary	Number of non elective GP visits for COPD	Number of non elective GP visits for COPD in the 6 months pre MISSION	6 month previous	No
Secondary	Number of non elective GP visits for COPD	Number of non elective GP visits for COPD in the 6 months post MISSION	6 months	No
Secondary	Number of hospital admissions for COPD	Number of hospital admissions for COPD in the 6 months pre MISSION	6 month previous	No
Secondary	Number of hospital admissions for COPD	Number of hospital admissions for COPD in the 6 months post MISSION	6 months	No
Secondary	Number of Emergency Department contacts for COPD	Number of Emergency Department contacts for COPD in the 6 months pre MISSION	6 month previous	No
Secondary	Number of Emergency Department contacts for COPD	Number of Emergency Department contacts for COPD in the 6 months post MISSION	6 months	No
Secondary	Number of out of hour (OOH) attendances/contacts for COPD	Number of out of hour attendances (OOH) contacts for COPD in the 6 months pre MISSION	6 month previous	No
Secondary	Number of out of hour (OOH) attendances/contacts for COPD	Number of out of hour attendances (OOH) contacts for COPD in the 6 months post MISSION	6 months	No
Secondary	Global initiative in chronic Obstructive Lung Disease (GOLD) score	To assess the severity of COPD by GOLD and BTS stage in the MISSION clinics	Baseline	No
Secondary	Measurement and variation of lung function.		Baseline	No
Secondary	Assessment of eosinophilic airways inflammation	Assessment of eosinophilic airways inflammation by Fractional Exhaled Nitric Oxide (FeNO) Assessment.	Baseline	No
Secondary	COPD controller medication	COPD controller medication in 6 months pre MISSION.	6 months previous	No
Secondary	COPD controller medication	COPD controller medication in 6 months post MISSION.	6 months	No
Secondary	Number of antibiotic courses without prednisolone for lower respiratory tract infections	Number of antibiotic courses without prednisolone for lower respiratory tract infections in 6 months pre MISSION	6 months previous	No
Secondary	Number of antibiotic courses without prednisolone for lower respiratory tract infections	Number of antibiotic courses without prednisolone for lower respiratory tract infections in 6 months post MISSION	6 months	No
Secondary	Short acting bronchodilator (SABA) use	Short acting bronchodilator (SABA) use measured by number of inhalers prescribed in 6 months pre MISSION.	6 months previous	No
Secondary	Short acting bronchodilator (SABA) use	Short acting bronchodilator (SABA) use measured by number of inhalers prescribed in 6 months post MISSION.	6 months	No
Secondary	Frequency and severity of co-morbidities	Frequency and severity of co morbidities including anxiety and depression, dysfunctional breathing, gastro oesophageal reflux and obstructive sleep apnoea in all patients.	Baseline	No
Secondary	Medication adherence	Medication adherence will be measured at baseline	Baseline	No
Secondary	Medication adherence	Medication adherence will be measured at 3 months	3 months	No
Secondary	Medication adherence	Medication adherence will be measured at 6 months	6 months	No
Secondary	Patient activation measure	Patients will complete the patient activation measure questionnaire at Baseline	Baseline	No
Secondary	Patient activation measure	Patients will complete the patient activation measure questionnaire at 3 months	3 months	No
Secondary	Patient activation measure	Patients will complete the patient activation measure questionnaire at 6 months	6 months	No
Secondary	Investigations performed	Investigations performed at the MISSION COPD clinics (e.g. sputum induction, High-Resolution Computed Tomography (HRCT) chest).	Baseline	No
Secondary	Hospital Anxiety and Depression Scale (HADS) score	HADS scores at baseline for patients attending the MISSION clinics	Baseline	No
Secondary	Hospital Anxiety and Depression Scale (HADS) score	HADS scores at 6 months for patients attending the MISSION clinics	6 months	No
Secondary	Gastroesophageal Reflux Disease Questionnaire (GERDQ) score	GERDQ scores at baseline for patients attending the Severe COPD Assessment Clinic (SCAC)	baseline	No
Secondary	Gastroesophageal Reflux Disease Questionnaire (GERDQ) score	GERDQ scores at 6 months for patients attending the Severe COPD Assessment Clinic (SCAC)	6 months	No
Secondary	Assessment of inhaler technique and recommendations for inhaler devices.		Baseline	No
Secondary	Smoking cessation advice		Baseline	No
Secondary	The frequency of non-attendance at clinic	The frequency of non-attendance at the MISSION clinic	Baseline	No

External Links

•   British Thoracic Society, 2006. Burden of lung disease
•   Department of Health, 2011. An outcomes strategy for people with chronic obstructive pulmonary disease (COPD) and asthma in England
•   Public Health England, 2014. Portsmouth Unitary Authority Health Profile 2014
•   Public Health England, 2015. Local Tobacco Control Proflies.