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

26. září 2016 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Aktuální)

114

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

    • Hampshire
      • Portsmouth, Hampshire, Spojené království, PO6 3LY
        • Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
COPD control measured by number of exacerbations treated with steroids and or antibiotics for ≥3 days
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
COPD Assessment Test (CAT) Score
Časové okno: baseline
patients will complete the CAT questionnaire to assess COPD control
baseline
COPD Assessment Test (CAT) Score
Časové okno: 3 months
patients will complete the CAT questionnaire to assess COPD control
3 months
COPD Assessment Test (CAT) Score
Časové okno: 6 months
patients will complete the CAT questionnaire to assess COPD control
6 months
St George's Respiratory Questionnaire (SGRQ)
Časové okno: baseline
baseline
St George's Respiratory Questionnaire (SGRQ)
Časové okno: 3 months
3 months
St George's Respiratory Questionnaire (SGRQ)
Časové okno: 6 months
6 months
Number of non elective GP visits for COPD
Časové okno: 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
Časové okno: 6 months
Number of non elective GP visits for COPD in the 6 months post MISSION
6 months
Number of hospital admissions for COPD
Časové okno: 6 month previous
Number of hospital admissions for COPD in the 6 months pre MISSION
6 month previous
Number of hospital admissions for COPD
Časové okno: 6 months
Number of hospital admissions for COPD in the 6 months post MISSION
6 months
Number of Emergency Department contacts for COPD
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Baseline
To assess the severity of COPD by GOLD and BTS stage in the MISSION clinics
Baseline
Measurement and variation of lung function.
Časové okno: Baseline
Baseline
Assessment of eosinophilic airways inflammation
Časové okno: Baseline
Assessment of eosinophilic airways inflammation by Fractional Exhaled Nitric Oxide (FeNO) Assessment.
Baseline
COPD controller medication
Časové okno: 6 months previous
COPD controller medication in 6 months pre MISSION.
6 months previous
COPD controller medication
Časové okno: 6 months
COPD controller medication in 6 months post MISSION.
6 months
Number of antibiotic courses without prednisolone for lower respiratory tract infections
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Baseline
Medication adherence will be measured at baseline
Baseline
Medication adherence
Časové okno: 3 months
Medication adherence will be measured at 3 months
3 months
Medication adherence
Časové okno: 6 months
Medication adherence will be measured at 6 months
6 months
Patient activation measure
Časové okno: Baseline
Patients will complete the patient activation measure questionnaire at Baseline
Baseline
Patient activation measure
Časové okno: 3 months
Patients will complete the patient activation measure questionnaire at 3 months
3 months
Patient activation measure
Časové okno: 6 months
Patients will complete the patient activation measure questionnaire at 6 months
6 months
Investigations performed
Časové okno: 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
Časové okno: Baseline
HADS scores at baseline for patients attending the MISSION clinics
Baseline
Hospital Anxiety and Depression Scale (HADS) score
Časové okno: 6 months
HADS scores at 6 months for patients attending the MISSION clinics
6 months
Gastroesophageal Reflux Disease Questionnaire (GERDQ) score
Časové okno: baseline
GERDQ scores at baseline for patients attending the Severe COPD Assessment Clinic (SCAC)
baseline
Gastroesophageal Reflux Disease Questionnaire (GERDQ) score
Časové okno: 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.
Časové okno: Baseline
Baseline
Smoking cessation advice
Časové okno: Baseline
Baseline
The frequency of non-attendance at clinic
Časové okno: Baseline
The frequency of non-attendance at the MISSION clinic
Baseline

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Spolupracovníci

Vyšetřovatelé

  • Vrchní vyšetřovatel: Professor Anoop J Chauhan, Portsmouth Hospitals NHS Trust

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. září 2015

Primární dokončení (Aktuální)

1. srpna 2016

Dokončení studie (Aktuální)

1. srpna 2016

Termíny zápisu do studia

První předloženo

25. srpna 2015

První předloženo, které splnilo kritéria kontroly kvality

25. srpna 2015

První zveřejněno (Odhad)

28. srpna 2015

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

27. září 2016

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

26. září 2016

Naposledy ověřeno

1. září 2016

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • PHT/2015/71

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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