- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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 de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Hampshire
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Portsmouth, Hampshire, Reino Unido, PO6 3LY
- Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
COPD control measured by number of exacerbations treated with steroids and or antibiotics for ≥3 days
Periodo de tiempo: 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.
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6 months previous
|
COPD control measured by number of exacerbations treated with steroids and or antibiotics for ≥3 days
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
COPD Assessment Test (CAT) Score
Periodo de tiempo: baseline
|
patients will complete the CAT questionnaire to assess COPD control
|
baseline
|
COPD Assessment Test (CAT) Score
Periodo de tiempo: 3 months
|
patients will complete the CAT questionnaire to assess COPD control
|
3 months
|
COPD Assessment Test (CAT) Score
Periodo de tiempo: 6 months
|
patients will complete the CAT questionnaire to assess COPD control
|
6 months
|
St George's Respiratory Questionnaire (SGRQ)
Periodo de tiempo: baseline
|
baseline
|
|
St George's Respiratory Questionnaire (SGRQ)
Periodo de tiempo: 3 months
|
3 months
|
|
St George's Respiratory Questionnaire (SGRQ)
Periodo de tiempo: 6 months
|
6 months
|
|
Number of non elective GP visits for COPD
Periodo de tiempo: 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
Periodo de tiempo: 6 months
|
Number of non elective GP visits for COPD in the 6 months post MISSION
|
6 months
|
Number of hospital admissions for COPD
Periodo de tiempo: 6 month previous
|
Number of hospital admissions for COPD in the 6 months pre MISSION
|
6 month previous
|
Number of hospital admissions for COPD
Periodo de tiempo: 6 months
|
Number of hospital admissions for COPD in the 6 months post MISSION
|
6 months
|
Number of Emergency Department contacts for COPD
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Baseline
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To assess the severity of COPD by GOLD and BTS stage in the MISSION clinics
|
Baseline
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Measurement and variation of lung function.
Periodo de tiempo: Baseline
|
Baseline
|
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Assessment of eosinophilic airways inflammation
Periodo de tiempo: Baseline
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Assessment of eosinophilic airways inflammation by Fractional Exhaled Nitric Oxide (FeNO) Assessment.
|
Baseline
|
COPD controller medication
Periodo de tiempo: 6 months previous
|
COPD controller medication in 6 months pre MISSION.
|
6 months previous
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COPD controller medication
Periodo de tiempo: 6 months
|
COPD controller medication in 6 months post MISSION.
|
6 months
|
Number of antibiotic courses without prednisolone for lower respiratory tract infections
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
|
Baseline
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Medication adherence
Periodo de tiempo: Baseline
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Medication adherence will be measured at baseline
|
Baseline
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Medication adherence
Periodo de tiempo: 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
Periodo de tiempo: 6 months
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Medication adherence will be measured at 6 months
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6 months
|
Patient activation measure
Periodo de tiempo: Baseline
|
Patients will complete the patient activation measure questionnaire at Baseline
|
Baseline
|
Patient activation measure
Periodo de tiempo: 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
Periodo de tiempo: 6 months
|
Patients will complete the patient activation measure questionnaire at 6 months
|
6 months
|
Investigations performed
Periodo de tiempo: 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
Periodo de tiempo: Baseline
|
HADS scores at baseline for patients attending the MISSION clinics
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Baseline
|
Hospital Anxiety and Depression Scale (HADS) score
Periodo de tiempo: 6 months
|
HADS scores at 6 months for patients attending the MISSION clinics
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6 months
|
Gastroesophageal Reflux Disease Questionnaire (GERDQ) score
Periodo de tiempo: baseline
|
GERDQ scores at baseline for patients attending the Severe COPD Assessment Clinic (SCAC)
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baseline
|
Gastroesophageal Reflux Disease Questionnaire (GERDQ) score
Periodo de tiempo: 6 months
|
GERDQ scores at 6 months for patients attending the Severe COPD Assessment Clinic (SCAC)
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6 months
|
Assessment of inhaler technique and recommendations for inhaler devices.
Periodo de tiempo: Baseline
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Baseline
|
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Smoking cessation advice
Periodo de tiempo: Baseline
|
Baseline
|
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The frequency of non-attendance at clinic
Periodo de tiempo: Baseline
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The frequency of non-attendance at the MISSION clinic
|
Baseline
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Professor Anoop J Chauhan, Portsmouth Hospitals NHS Trust
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PHT/2015/71
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .