MISSION COPD - Modern Innovative SolutionS in Improving Outcomes iN COPD

NCT02534766

Last updated date
Study Location
Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital
Portsmouth, Hampshire, PO6 3LY, United Kingdom
Contact
1-800-718-1021

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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Obstructive Pulmonary Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Health Care Professionals


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

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Advanced Information
Descriptive Information
Brief Title 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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Pulmonary Disease, Chronic Obstructive
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 26, 2016)
114
Original Estimated Enrollment
 (submitted: August 25, 2015)
150
Actual Study Completion Date August 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
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

Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT02534766
Other Study ID Numbers PHT/2015/71
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Portsmouth Hospitals NHS Trust
Study Sponsor Portsmouth Hospitals NHS Trust
Collaborators Pfizer
Investigators
Principal Investigator:Professor Anoop J ChauhanPortsmouth Hospitals NHS Trust
PRS Account Portsmouth Hospitals NHS Trust
Verification Date September 2016