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

26 settembre 2016 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

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

Osservativo

Iscrizione (Effettivo)

114

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Hampshire
      • Portsmouth, Hampshire, Regno Unito, PO6 3LY
        • Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

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

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
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.

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
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
Lasso di tempo: 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
Lasso di tempo: 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
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
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
COPD Assessment Test (CAT) Score
Lasso di tempo: 3 months
patients will complete the CAT questionnaire to assess COPD control
3 months
COPD Assessment Test (CAT) Score
Lasso di tempo: 6 months
patients will complete the CAT questionnaire to assess COPD control
6 months
St George's Respiratory Questionnaire (SGRQ)
Lasso di tempo: baseline
baseline
St George's Respiratory Questionnaire (SGRQ)
Lasso di tempo: 3 months
3 months
St George's Respiratory Questionnaire (SGRQ)
Lasso di tempo: 6 months
6 months
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
6 month previous
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
6 months
Number of hospital admissions for COPD
Lasso di tempo: 6 month previous
Number of hospital admissions for COPD in the 6 months pre MISSION
6 month previous
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
Number of Emergency Department contacts for COPD
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline
To assess the severity of COPD by GOLD and BTS stage in the MISSION clinics
Baseline
Measurement and variation of lung function.
Lasso di tempo: Baseline
Baseline
Assessment of eosinophilic airways inflammation
Lasso di tempo: Baseline
Assessment of eosinophilic airways inflammation by Fractional Exhaled Nitric Oxide (FeNO) Assessment.
Baseline
COPD controller medication
Lasso di tempo: 6 months previous
COPD controller medication in 6 months pre MISSION.
6 months previous
COPD controller medication
Lasso di tempo: 6 months
COPD controller medication in 6 months post MISSION.
6 months
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
6 months previous
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
Short acting bronchodilator (SABA) use
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline
Medication adherence will be measured at baseline
Baseline
Medication adherence
Lasso di tempo: 3 months
Medication adherence will be measured at 3 months
3 months
Medication adherence
Lasso di tempo: 6 months
Medication adherence will be measured at 6 months
6 months
Patient activation measure
Lasso di tempo: Baseline
Patients will complete the patient activation measure questionnaire at Baseline
Baseline
Patient activation measure
Lasso di tempo: 3 months
Patients will complete the patient activation measure questionnaire at 3 months
3 months
Patient activation measure
Lasso di tempo: 6 months
Patients will complete the patient activation measure questionnaire at 6 months
6 months
Investigations performed
Lasso di tempo: 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
Lasso di tempo: Baseline
HADS scores at baseline for patients attending the MISSION clinics
Baseline
Hospital Anxiety and Depression Scale (HADS) score
Lasso di tempo: 6 months
HADS scores at 6 months for patients attending the MISSION clinics
6 months
Gastroesophageal Reflux Disease Questionnaire (GERDQ) score
Lasso di tempo: baseline
GERDQ scores at baseline for patients attending the Severe COPD Assessment Clinic (SCAC)
baseline
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)
6 months
Assessment of inhaler technique and recommendations for inhaler devices.
Lasso di tempo: Baseline
Baseline
Smoking cessation advice
Lasso di tempo: Baseline
Baseline
The frequency of non-attendance at clinic
Lasso di tempo: Baseline
The frequency of non-attendance at the MISSION clinic
Baseline

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Collaboratori

Investigatori

  • Investigatore principale: Professor Anoop J Chauhan, Portsmouth Hospitals NHS Trust

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 settembre 2015

Completamento primario (Effettivo)

1 agosto 2016

Completamento dello studio (Effettivo)

1 agosto 2016

Date di iscrizione allo studio

Primo inviato

25 agosto 2015

Primo inviato che soddisfa i criteri di controllo qualità

25 agosto 2015

Primo Inserito (Stima)

28 agosto 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

27 settembre 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

26 settembre 2016

Ultimo verificato

1 settembre 2016

Maggiori informazioni

Termini relativi a questo studio

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 .

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