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

26 de septiembre de 2016 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

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

De observación

Inscripción (Actual)

114

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Hampshire
      • Portsmouth, Hampshire, Reino Unido, PO6 3LY
        • Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

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.

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

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
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.

¿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.
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
To assess the severity of COPD by GOLD and BTS stage in the MISSION clinics
Baseline
Measurement and variation of lung function.
Periodo de tiempo: Baseline
Baseline
Assessment of eosinophilic airways inflammation
Periodo de tiempo: Baseline
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
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.
6 months
Frequency and severity of co-morbidities
Periodo de tiempo: 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
Periodo de tiempo: Baseline
Medication adherence will be measured at baseline
Baseline
Medication adherence
Periodo de tiempo: 3 months
Medication adherence will be measured at 3 months
3 months
Medication adherence
Periodo de tiempo: 6 months
Medication adherence will be measured at 6 months
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
3 months
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
Baseline
Hospital Anxiety and Depression Scale (HADS) score
Periodo de tiempo: 6 months
HADS scores at 6 months for patients attending the MISSION clinics
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)
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)
6 months
Assessment of inhaler technique and recommendations for inhaler devices.
Periodo de tiempo: Baseline
Baseline
Smoking cessation advice
Periodo de tiempo: Baseline
Baseline
The frequency of non-attendance at clinic
Periodo de tiempo: Baseline
The frequency of non-attendance at the MISSION clinic
Baseline

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Colaboradores

Investigadores

  • Investigador principal: Professor Anoop J Chauhan, Portsmouth Hospitals NHS Trust

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de septiembre de 2015

Finalización primaria (Actual)

1 de agosto de 2016

Finalización del estudio (Actual)

1 de agosto de 2016

Fechas de registro del estudio

Enviado por primera vez

25 de agosto de 2015

Primero enviado que cumplió con los criterios de control de calidad

25 de agosto de 2015

Publicado por primera vez (Estimar)

28 de agosto de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

27 de septiembre de 2016

Última actualización enviada que cumplió con los criterios de control de calidad

26 de septiembre de 2016

Última verificación

1 de septiembre de 2016

Más información

Términos relacionados con este estudio

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. .

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