Tämä sivu käännettiin automaattisesti, eikä käännösten tarkkuutta voida taata. Katso englanninkielinen versio lähdetekstiä varten.

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

maanantai 26. syyskuuta 2016 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Yksityiskohtainen kuvaus

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.

Opintotyyppi

Havainnollistava

Ilmoittautuminen (Todellinen)

114

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

    • Hampshire
      • Portsmouth, Hampshire, Yhdistynyt kuningaskunta, PO6 3LY
        • Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Joo

Sukupuolet, jotka voivat opiskella

Kaikki

Näytteenottomenetelmä

Ei-todennäköisyysnäyte

Tutkimusväestö

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.

Kuvaus

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

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

Kohortit ja interventiot

Ryhmä/Kohortti
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.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
COPD control measured by number of exacerbations treated with steroids and or antibiotics for ≥3 days
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Yhteistyökumppanit

Tutkijat

  • Päätutkija: Professor Anoop J Chauhan, Portsmouth Hospitals NHS Trust

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus

Tiistai 1. syyskuuta 2015

Ensisijainen valmistuminen (Todellinen)

Maanantai 1. elokuuta 2016

Opintojen valmistuminen (Todellinen)

Maanantai 1. elokuuta 2016

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Tiistai 25. elokuuta 2015

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Tiistai 25. elokuuta 2015

Ensimmäinen Lähetetty (Arvio)

Perjantai 28. elokuuta 2015

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Arvio)

Tiistai 27. syyskuuta 2016

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Maanantai 26. syyskuuta 2016

Viimeksi vahvistettu

Torstai 1. syyskuuta 2016

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Muut tutkimustunnusnumerot

  • PHT/2015/71

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

3
Tilaa