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

26 september 2016 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Longziekte, chronisch obstructief

Gedetailleerde beschrijving

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

Observationeel

Inschrijving (Werkelijk)

114

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Verenigd Koninkrijk
- Hampshire
  - Portsmouth, Hampshire, Verenigd Koninkrijk, PO6 3LY
    - Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Aantal groepen / cohorten

Cohorten en interventies

Groep / 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
COPD control measured by number of exacerbations treated with steroids and or antibiotics for ≥3 days Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Portsmouth Hospitals NHS Trust

Medewerkers

Pfizer

Onderzoekers

Hoofdonderzoeker: Professor Anoop J Chauhan, Portsmouth Hospitals NHS Trust

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 september 2015

Primaire voltooiing (Werkelijk)

1 augustus 2016

Studie voltooiing (Werkelijk)

1 augustus 2016

Studieregistratiedata

Eerst ingediend

25 augustus 2015

Eerst ingediend dat voldeed aan de QC-criteria

25 augustus 2015

Eerst geplaatst (Schatting)

28 augustus 2015

Updates van studierecords

Laatste update geplaatst (Schatting)

27 september 2016

Laatste update ingediend die voldeed aan QC-criteria

26 september 2016

Laatst geverifieerd

1 september 2016

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

PHT/2015/71

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