MISSION COPD - Modern Innovative SolutionS in Improving Outcomes iN COPD (MISSION-COPD)

September 26, 2016 updated by: Portsmouth Hospitals NHS Trust

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

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.

Study Overview

Status

Completed

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.

Study Type

Observational

Enrollment (Actual)

114

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Hampshire
      • Portsmouth, Hampshire, United Kingdom, PO6 3LY
        • Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months previous
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.
6 months
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
6 months previous
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
COPD Assessment Test (CAT) Score
Time Frame: baseline
patients will complete the CAT questionnaire to assess COPD control
baseline
COPD Assessment Test (CAT) Score
Time Frame: 3 months
patients will complete the CAT questionnaire to assess COPD control
3 months
COPD Assessment Test (CAT) Score
Time Frame: 6 months
patients will complete the CAT questionnaire to assess COPD control
6 months
St George's Respiratory Questionnaire (SGRQ)
Time Frame: baseline
baseline
St George's Respiratory Questionnaire (SGRQ)
Time Frame: 3 months
3 months
St George's Respiratory Questionnaire (SGRQ)
Time Frame: 6 months
6 months
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
6 month previous
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
6 months
Number of hospital admissions for COPD
Time Frame: 6 month previous
Number of hospital admissions for COPD in the 6 months pre MISSION
6 month previous
Number of hospital admissions for COPD
Time Frame: 6 months
Number of hospital admissions for COPD in the 6 months post MISSION
6 months
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
6 month previous
Number of Emergency Department contacts for COPD
Time Frame: 6 months
Number of Emergency Department contacts for COPD in the 6 months post MISSION
6 months
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
6 month previous
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
6 months
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
Baseline
Measurement and variation of lung function.
Time Frame: Baseline
Baseline
Assessment of eosinophilic airways inflammation
Time Frame: Baseline
Assessment of eosinophilic airways inflammation by Fractional Exhaled Nitric Oxide (FeNO) Assessment.
Baseline
COPD controller medication
Time Frame: 6 months previous
COPD controller medication in 6 months pre MISSION.
6 months previous
COPD controller medication
Time Frame: 6 months
COPD controller medication in 6 months post MISSION.
6 months
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
6 months previous
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
6 months
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.
6 months previous
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.
6 months
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.
Baseline
Medication adherence
Time Frame: Baseline
Medication adherence will be measured at baseline
Baseline
Medication adherence
Time Frame: 3 months
Medication adherence will be measured at 3 months
3 months
Medication adherence
Time Frame: 6 months
Medication adherence will be measured at 6 months
6 months
Patient activation measure
Time Frame: Baseline
Patients will complete the patient activation measure questionnaire at Baseline
Baseline
Patient activation measure
Time Frame: 3 months
Patients will complete the patient activation measure questionnaire at 3 months
3 months
Patient activation measure
Time Frame: 6 months
Patients will complete the patient activation measure questionnaire at 6 months
6 months
Investigations performed
Time Frame: Baseline
Investigations performed at the MISSION COPD clinics (e.g. sputum induction, High-Resolution Computed Tomography (HRCT) chest).
Baseline
Hospital Anxiety and Depression Scale (HADS) score
Time Frame: Baseline
HADS scores at baseline for patients attending the MISSION clinics
Baseline
Hospital Anxiety and Depression Scale (HADS) score
Time Frame: 6 months
HADS scores at 6 months for patients attending the MISSION clinics
6 months
Gastroesophageal Reflux Disease Questionnaire (GERDQ) score
Time Frame: baseline
GERDQ scores at baseline for patients attending the Severe COPD Assessment Clinic (SCAC)
baseline
Gastroesophageal Reflux Disease Questionnaire (GERDQ) score
Time Frame: 6 months
GERDQ scores at 6 months for patients attending the Severe COPD Assessment Clinic (SCAC)
6 months
Assessment of inhaler technique and recommendations for inhaler devices.
Time Frame: Baseline
Baseline
Smoking cessation advice
Time Frame: Baseline
Baseline
The frequency of non-attendance at clinic
Time Frame: Baseline
The frequency of non-attendance at the MISSION clinic
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Professor Anoop J Chauhan, Portsmouth Hospitals NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

August 25, 2015

First Submitted That Met QC Criteria

August 25, 2015

First Posted (Estimate)

August 28, 2015

Study Record Updates

Last Update Posted (Estimate)

September 27, 2016

Last Update Submitted That Met QC Criteria

September 26, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • PHT/2015/71

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pulmonary Disease, Chronic Obstructive

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