- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Hampshire
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Portsmouth, Hampshire, Regno Unito, PO6 3LY
- Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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
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Health Care Professionals
Health Care Professionals who attended the MISSION COPD clinics in a professional/ clinical capacity.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
COPD control measured by number of exacerbations treated with steroids and or antibiotics for ≥3 days
Lasso di tempo: 6 months previous
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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.
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6 months previous
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COPD control measured by number of exacerbations treated with steroids and or antibiotics for ≥3 days
Lasso di tempo: 6 months
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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.
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6 months
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Number of exacerbations of COPD that require hospital admission and treatment
Lasso di tempo: 6 months previous
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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
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6 months previous
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Number of exacerbations of COPD that require hospital admission and treatment
Lasso di tempo: 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
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6 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
COPD Assessment Test (CAT) Score
Lasso di tempo: baseline
|
patients will complete the CAT questionnaire to assess COPD control
|
baseline
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COPD Assessment Test (CAT) Score
Lasso di tempo: 3 months
|
patients will complete the CAT questionnaire to assess COPD control
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3 months
|
COPD Assessment Test (CAT) Score
Lasso di tempo: 6 months
|
patients will complete the CAT questionnaire to assess COPD control
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6 months
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St George's Respiratory Questionnaire (SGRQ)
Lasso di tempo: baseline
|
baseline
|
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St George's Respiratory Questionnaire (SGRQ)
Lasso di tempo: 3 months
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3 months
|
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St George's Respiratory Questionnaire (SGRQ)
Lasso di tempo: 6 months
|
6 months
|
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Number of non elective GP visits for COPD
Lasso di tempo: 6 month previous
|
Number of non elective GP visits for COPD in the 6 months pre MISSION
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6 month previous
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Number of non elective GP visits for COPD
Lasso di tempo: 6 months
|
Number of non elective GP visits for COPD in the 6 months post MISSION
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6 months
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Number of hospital admissions for COPD
Lasso di tempo: 6 month previous
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Number of hospital admissions for COPD in the 6 months pre MISSION
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6 month previous
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Number of hospital admissions for COPD
Lasso di tempo: 6 months
|
Number of hospital admissions for COPD in the 6 months post MISSION
|
6 months
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Number of Emergency Department contacts for COPD
Lasso di tempo: 6 month previous
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Number of Emergency Department contacts for COPD in the 6 months pre MISSION
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6 month previous
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Number of Emergency Department contacts for COPD
Lasso di tempo: 6 months
|
Number of Emergency Department contacts for COPD in the 6 months post MISSION
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6 months
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Number of out of hour (OOH) attendances/contacts for COPD
Lasso di tempo: 6 month previous
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Number of out of hour attendances (OOH) contacts for COPD in the 6 months pre MISSION
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6 month previous
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Number of out of hour (OOH) attendances/contacts for COPD
Lasso di tempo: 6 months
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Number of out of hour attendances (OOH) contacts for COPD in the 6 months post MISSION
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6 months
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Global initiative in chronic Obstructive Lung Disease (GOLD) score
Lasso di tempo: Baseline
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To assess the severity of COPD by GOLD and BTS stage in the MISSION clinics
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Baseline
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Measurement and variation of lung function.
Lasso di tempo: Baseline
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Baseline
|
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Assessment of eosinophilic airways inflammation
Lasso di tempo: Baseline
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Assessment of eosinophilic airways inflammation by Fractional Exhaled Nitric Oxide (FeNO) Assessment.
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Baseline
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COPD controller medication
Lasso di tempo: 6 months previous
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COPD controller medication in 6 months pre MISSION.
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6 months previous
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COPD controller medication
Lasso di tempo: 6 months
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COPD controller medication in 6 months post MISSION.
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6 months
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Number of antibiotic courses without prednisolone for lower respiratory tract infections
Lasso di tempo: 6 months previous
|
Number of antibiotic courses without prednisolone for lower respiratory tract infections in 6 months pre MISSION
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6 months previous
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Number of antibiotic courses without prednisolone for lower respiratory tract infections
Lasso di tempo: 6 months
|
Number of antibiotic courses without prednisolone for lower respiratory tract infections in 6 months post MISSION
|
6 months
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Short acting bronchodilator (SABA) use
Lasso di tempo: 6 months previous
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Short acting bronchodilator (SABA) use measured by number of inhalers prescribed in 6 months pre MISSION.
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6 months previous
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Short acting bronchodilator (SABA) use
Lasso di tempo: 6 months
|
Short acting bronchodilator (SABA) use measured by number of inhalers prescribed in 6 months post MISSION.
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6 months
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Frequency and severity of co-morbidities
Lasso di tempo: Baseline
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Frequency and severity of co morbidities including anxiety and depression, dysfunctional breathing, gastro oesophageal reflux and obstructive sleep apnoea in all patients.
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Baseline
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Medication adherence
Lasso di tempo: Baseline
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Medication adherence will be measured at baseline
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Baseline
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Medication adherence
Lasso di tempo: 3 months
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Medication adherence will be measured at 3 months
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3 months
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Medication adherence
Lasso di tempo: 6 months
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Medication adherence will be measured at 6 months
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6 months
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Patient activation measure
Lasso di tempo: Baseline
|
Patients will complete the patient activation measure questionnaire at Baseline
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Baseline
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Patient activation measure
Lasso di tempo: 3 months
|
Patients will complete the patient activation measure questionnaire at 3 months
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3 months
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Patient activation measure
Lasso di tempo: 6 months
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Patients will complete the patient activation measure questionnaire at 6 months
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6 months
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Investigations performed
Lasso di tempo: Baseline
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Investigations performed at the MISSION COPD clinics (e.g.
sputum induction, High-Resolution Computed Tomography (HRCT) chest).
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Baseline
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Hospital Anxiety and Depression Scale (HADS) score
Lasso di tempo: Baseline
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HADS scores at baseline for patients attending the MISSION clinics
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Baseline
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Hospital Anxiety and Depression Scale (HADS) score
Lasso di tempo: 6 months
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HADS scores at 6 months for patients attending the MISSION clinics
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6 months
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Gastroesophageal Reflux Disease Questionnaire (GERDQ) score
Lasso di tempo: baseline
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GERDQ scores at baseline for patients attending the Severe COPD Assessment Clinic (SCAC)
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baseline
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Gastroesophageal Reflux Disease Questionnaire (GERDQ) score
Lasso di tempo: 6 months
|
GERDQ scores at 6 months for patients attending the Severe COPD Assessment Clinic (SCAC)
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6 months
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Assessment of inhaler technique and recommendations for inhaler devices.
Lasso di tempo: Baseline
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Baseline
|
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Smoking cessation advice
Lasso di tempo: Baseline
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Baseline
|
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The frequency of non-attendance at clinic
Lasso di tempo: Baseline
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The frequency of non-attendance at the MISSION clinic
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Baseline
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Professor Anoop J Chauhan, Portsmouth Hospitals NHS Trust
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
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Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- PHT/2015/71
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .