- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02534766
MISSION COPD - Modern Innovative SolutionS in Improving Outcomes iN COPD (MISSION-COPD)
MISSION COPD - Modern Innovative SolutionS in Improving Outcomes iN - COPD - A Comparison of Clinical Outcomes Before and After the MISSION Clinic.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
Hampshire
-
Portsmouth, Hampshire, Storbritannia, PO6 3LY
- Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
---|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
COPD control measured by number of exacerbations treated with steroids and or antibiotics for ≥3 days
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
COPD Assessment Test (CAT) Score
Tidsramme: baseline
|
patients will complete the CAT questionnaire to assess COPD control
|
baseline
|
COPD Assessment Test (CAT) Score
Tidsramme: 3 months
|
patients will complete the CAT questionnaire to assess COPD control
|
3 months
|
COPD Assessment Test (CAT) Score
Tidsramme: 6 months
|
patients will complete the CAT questionnaire to assess COPD control
|
6 months
|
St George's Respiratory Questionnaire (SGRQ)
Tidsramme: baseline
|
baseline
|
|
St George's Respiratory Questionnaire (SGRQ)
Tidsramme: 3 months
|
3 months
|
|
St George's Respiratory Questionnaire (SGRQ)
Tidsramme: 6 months
|
6 months
|
|
Number of non elective GP visits for COPD
Tidsramme: 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
Tidsramme: 6 months
|
Number of non elective GP visits for COPD in the 6 months post MISSION
|
6 months
|
Number of hospital admissions for COPD
Tidsramme: 6 month previous
|
Number of hospital admissions for COPD in the 6 months pre MISSION
|
6 month previous
|
Number of hospital admissions for COPD
Tidsramme: 6 months
|
Number of hospital admissions for COPD in the 6 months post MISSION
|
6 months
|
Number of Emergency Department contacts for COPD
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline
|
To assess the severity of COPD by GOLD and BTS stage in the MISSION clinics
|
Baseline
|
Measurement and variation of lung function.
Tidsramme: Baseline
|
Baseline
|
|
Assessment of eosinophilic airways inflammation
Tidsramme: Baseline
|
Assessment of eosinophilic airways inflammation by Fractional Exhaled Nitric Oxide (FeNO) Assessment.
|
Baseline
|
COPD controller medication
Tidsramme: 6 months previous
|
COPD controller medication in 6 months pre MISSION.
|
6 months previous
|
COPD controller medication
Tidsramme: 6 months
|
COPD controller medication in 6 months post MISSION.
|
6 months
|
Number of antibiotic courses without prednisolone for lower respiratory tract infections
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline
|
Medication adherence will be measured at baseline
|
Baseline
|
Medication adherence
Tidsramme: 3 months
|
Medication adherence will be measured at 3 months
|
3 months
|
Medication adherence
Tidsramme: 6 months
|
Medication adherence will be measured at 6 months
|
6 months
|
Patient activation measure
Tidsramme: Baseline
|
Patients will complete the patient activation measure questionnaire at Baseline
|
Baseline
|
Patient activation measure
Tidsramme: 3 months
|
Patients will complete the patient activation measure questionnaire at 3 months
|
3 months
|
Patient activation measure
Tidsramme: 6 months
|
Patients will complete the patient activation measure questionnaire at 6 months
|
6 months
|
Investigations performed
Tidsramme: 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
Tidsramme: Baseline
|
HADS scores at baseline for patients attending the MISSION clinics
|
Baseline
|
Hospital Anxiety and Depression Scale (HADS) score
Tidsramme: 6 months
|
HADS scores at 6 months for patients attending the MISSION clinics
|
6 months
|
Gastroesophageal Reflux Disease Questionnaire (GERDQ) score
Tidsramme: baseline
|
GERDQ scores at baseline for patients attending the Severe COPD Assessment Clinic (SCAC)
|
baseline
|
Gastroesophageal Reflux Disease Questionnaire (GERDQ) score
Tidsramme: 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.
Tidsramme: Baseline
|
Baseline
|
|
Smoking cessation advice
Tidsramme: Baseline
|
Baseline
|
|
The frequency of non-attendance at clinic
Tidsramme: Baseline
|
The frequency of non-attendance at the MISSION clinic
|
Baseline
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Professor Anoop J Chauhan, Portsmouth Hospitals NHS Trust
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PHT/2015/71
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