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MISSION Severe Asthma Modern Innovative Solutions to Improve Outcomes in Severe Asthma. (MISSION)

26 de septiembre de 2016 actualizado por: Portsmouth Hospitals NHS Trust

MISSION Severe Asthma: Modern Innovative Solutions to Improve Outcomes in Severe Asthma. A Mixed Methods Observational Comparison of Clinical Outcomes in MISSION Versus Current Care Delivery.

MISSION is a new and novel way of delivering highly specialised asthma care and has the potential to change the way asthma care across the United Kingdom (UK) is delivered as well as services for other long term health conditions. The MISSION model is the first model of this type and the current research study aims to evaluate its success and to compare the MISSION service to current care delivery. 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 intervention using retrospective data analysis and prospective qualitative interview. A control arm of patients not exposed to, but eligible for, the new intervention will also be included. The study will be conducted at Portsmouth Hospitals National Health Service (NHS) Trust and will recruit patients who attended MISSION clinics, outpatient asthma clinics, staff who attended MISSION clinics in a professional capacity and patients from GP surgeries where MISSION clinics were held who did not attend.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

Purpose and design

The purpose of the study is to evaluate in detail the clinical and health economic outcomes from the MISSION project. The MISSION clinics combined a new way of delivering asthma care along with actively case finding patients who were not already known to specialist services but who had uncontrolled or at risk asthma.

The aim of the study is to compare the MISSION clinic model outcomes to current clinic model outcomes as well as performing qualitative interviews with patients who attended and staff who took part in the project.The research study was developed by a team from Portsmouth Hospital Trust and the University of Portsmouth including a research fellow, consultant and Professor, research methodologist, qualitative senior lecturer and independent statistician. A patient adviser also reviewed the lay summary and patient information sheets. The study undergoes independent review by another clinician as part of the sponsor process.

The study is also part of an MD project for the University of Portsmouth.

Design:

This is a mixed methods study.

A quantitative analysis of data from patients who attended the MISSION Rapid Access Asthma Clinics (RAAC), patients who attended the MISSION Severe Asthma Assessment Clinics (SAAC), patients who were invited to the RAAC but did not attend and patients who have been referred by their GP to the severe asthma clinic during the same time MISSION was running. The data analysis will include asthma control, hospital admissions, GP appointments, related medical conditions,medications, investigations and assessments done and time between appointments.

A qualitative study will be conducted using telephone interviews with patients who attended the SAAC and health care professionals who took part in the MISSION clinics.

The aim is to recruit:

  • 44 MISSION patients (of whom 20 attended both the RAAC and the SAAC),
  • 132 patients who were invited to MISSION RAAC but did not attend
  • 20 patients referred to the severe asthma clinic at the hospital
  • 20 health care professionals who took part in the MISSION clinics

Methodology:

Participants will be approached for consent by post. They will be given time to read the information and return the consent form to the study team. They will be given a contact number to discuss any questions.

Once a participant has consented to the quantitative study there is no further study procedures for the participant. Participants will be asked for consent to collect data from their GP and hospital records for the study. This will be entered onto a form (CRF) against a study number and then into a password protected study database held on a secure server at Portsmouth Hospitals NHS Trust. This data will then be analysed by a statistician and research fellow.

Participants for qualitative interview will have an interview over the telephone lasting 45 minutes to one hour. This will be recorded and transcribed. The participant will be given the transcript to read and correct. The transcripts will then be analysed looking for themes.

Tipo de estudio

De observación

Inscripción (Actual)

92

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 de probabilidad

Población de estudio

Participants with uncontrolled or potentially severe asthma identified from GP records by the MISSION team and new referrals to an asthma specialist clinic at Queen Alexandra Hospital between May and August 2014.

Study participants for qualitative interview will be recruited from patients who attended MISSION SAAC days and staff who attended MISSION RAAC or SAAC days.

Descripción

Inclusion Criteria:

  • Male or Female, aged 18 years or above.
  • Is in one of the following population groups:
  • Attended the MISSION RAAC or
  • Attended the MISSION SAAC or
  • Identified as uncontrolled asthma by record searches and invited to MISSION RAAC but did not attend - 'primary care patients' or
  • Has been referred to the specialist asthma clinic at Queen Alexandra Hospital - 'outpatient severe asthma patients' or
  • Attended the MISSION RAAC or SAAC as a health care professional
  • Participant is willing and able to give informed consent for participation in the study.

Exclusion Criteria:

  • The patient 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 RAAC/SAAC.
Patients who have previously attended the Rapid Access Asthma Clinic (RAAC) will be approached for the quantitative study. Patients who went onto the attend the Severe Asthma Assessment Clinics (SAAC) will also be approached for the quantitative and qualitive parts of the study.
Patients eligible for RAAC, but DNA'd
Patients identified by the GP search, who did not attend the previous MISSION clinics will be approached to participate in the quantitative part of the study.
Asthma Outpatients
Patients who are attending outpatient clinics as new referrals will be approached to participate in the quantitative part of the study.
Healthcare Professionals
Healthcare professionals who performed the MISSION RAAC or SAAC will be approached for qualitative interview part of the study only.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Asthma control as measured by exacerbation frequency for all patients
Periodo de tiempo: 6 months
The primary endpoint is asthma control as measured by exacerbation frequency (defined as deterioration in symptoms requiring ≥30mg prednisolone or equivalent for ≥3 days) for all patients
6 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Short acting bronchodilator (SABA) use
Periodo de tiempo: 6 months
Short acting bronchodilator (SABA) use measured by number of inhalers prescribed in 6 months pre and post MISSION SAAC, RAAC or outpatient clinic.
6 months
Exacerbation frequency
Periodo de tiempo: 6 months
Exacerbation frequency (defined as deterioration in symptoms requiring ≥30mg prednisolone or equivalent for ≥3 days) in 6 months pre and post MISSION SAAC, RAAC or outpatient clinic.
6 months
Health care usage costs for asthma and number of contacts
Periodo de tiempo: 6 months
Health care usage costs for asthma and number of contacts (GP visits, Emergency Department (ED) or out of hour attendances (OOH), hospital admissions, emergency GP visits) over 6 months pre and post MISSION or outpatient clinic.
6 months
Assessment of co-morbidity
Periodo de tiempo: 6 months
Assessment of comorbidity (rhinosinusitis, anxiety and depression, dysfunctional breathing, gastro oesophageal reflux and obstructive sleep apnoea) and method of assessment for MISSION SAAC patients and outpatient severe asthma clinic patients
6 months
Assessment of inhaler technique and recommendations for inhaler devices.
Periodo de tiempo: 6 months
Assessment of inhaler technique and recommendations for inhaler devices for MISSION SAAC patients and outpatient severe asthma clinic patients
6 months
Smoking cessation advice.
Periodo de tiempo: 6 months
Smoking cessation advice for MISSION SAAC patients and outpatient severe asthma clinic patients
6 months
Investigations performed in secondary care
Periodo de tiempo: 6 months
Investigations performed during 6 months in secondary care e.g. full lung function, sputum induction, High-Resolution Computed Tomography (HRCT) chest for MISSION SAAC patients and outpatient severe asthma clinic patients
6 months
Time from GP referral to 1st clinic visit
Periodo de tiempo: 6 months
Time from GP referral to 1st clinic visit in secondary care for MISSION SAAC patients and outpatient severe asthma clinic patients
6 months
Time between 1st and 2nd visit
Periodo de tiempo: 6 months
Time between 1st and 2nd visit in secondary care for MISSION SAAC patients and outpatient severe asthma clinic patients
6 months
Time to appointment with other specialists
Periodo de tiempo: 6 months
Time to appoint with other specialists for asthma related comorbidity where indicated, e.g. dietician, Ear, Nose & Throat (ENT), physiotherapists, psychologist, CT imaging for MISSION SAAC patients and outpatient severe asthma clinic patients
6 months
Fractional Exhaled Nitric Oxide (FeNO) Assessment
Periodo de tiempo: 6 months
Assessment of eosinophilic airways inflammation by FeNO for MISSION SAAC patients and outpatient severe asthma clinic patients
6 months
Frequency of non-attendance
Periodo de tiempo: 6 months
The frequency of non-attendance at clinic for MISSION SAAC patients and outpatient severe asthma clinic patients
6 months
Severity of co-morbidities
Periodo de tiempo: 6 months
Severity of co-morbidities for MISSION RAAC patients
6 months
Frequency of co-morbidities
Periodo de tiempo: 6 months
Frequency of co-morbidities for MISSION RAAC patients
6 months
Frequency & type of allergy
Periodo de tiempo: 6 months
Frequency & type of allergy for MISSION RAAC patients
6 months
Measurement of exhaled nitric oxide
Periodo de tiempo: 6 months
Measurement of exhaled nitric oxide for MISSION RAAC patients
6 months
Measurement & variation of lung function (Single
Periodo de tiempo: 6 months
Composite measurement & variation of lung function for MISSION RAAC patients
6 months
Frequency and type of additional asthma control medication.
Periodo de tiempo: 6 months
Frequency and type of additional asthma control medication for MISSION RAAC patients
6 months
Quality of life
Periodo de tiempo: 6 months
Quality of life as assessed by the Asthma Quality of Life Questionnaire (AQLQ).
6 months
Disease control
Periodo de tiempo: 6 months
Disease control as assessed by the Asthma Control Questionnaire (ACQ)
6 months
Number of Forced Expiratory Volume at one second (FEV1) / Forced Vital Capacity (FVC) measurements
Periodo de tiempo: 6 months
Number of patients having measurements of FEV1/FVC as a proxy for asthma control and severity in the MISSION RAAC patient and primary care patients
6 months
Prescription of SABA's
Periodo de tiempo: 6 months previous
Prescription of Short Acting Bronchodilators (SABAs) during last 6 months at baseline and 6 months for MISSION RAAC and primary care patients.
6 months previous
Prescription of SABA's
Periodo de tiempo: Baseline
Prescription of Short Acting Bronchodilators (SABAs) during last 6 months at baseline and 6 months for MISSION RAAC and primary care patients.
Baseline
Prescription of SABA's
Periodo de tiempo: 6 months
Prescription of Short Acting Bronchodilators (SABAs) during last 6 months at baseline and 6 months for MISSION RAAC and primary care patients.
6 months
Exacerbation rates
Periodo de tiempo: 6 months previous
Exacerbation rates (defined as deterioration in symptoms requiring ≥30mg prednisolone or equivalent for ≥3 days) during the last 6 months at baseline and 6 months for MISSION RAAC and primary care patients.
6 months previous
Exacerbation rates
Periodo de tiempo: Baseline
Exacerbation rates (defined as deterioration in symptoms requiring ≥30mg prednisolone or equivalent for ≥3 days) during the last 6 months at baseline and 6 months for MISSION RAAC and primary care patients.
Baseline
Exacerbation rates
Periodo de tiempo: 6 months
Exacerbation rates (defined as deterioration in symptoms requiring ≥30mg prednisolone or equivalent for ≥3 days) during the last 6 months at baseline and 6 months for MISSION RAAC and primary care patients.
6 months
ED attendances during the last 6 months
Periodo de tiempo: 6 months previous
Emergency Department (ED) attendances during the last 6 months at baseline and 6 months for MISSION RAAC and primary care patients.
6 months previous
Out Of Hours (OOH) contacts during the last 6 months
Periodo de tiempo: 6 months previous
Out Of Hours (OOH) contacts during the last 6 months at baseline and 6 months for MISSION RAAC and primary care patients.
6 months previous
Hospital admissions during the last 6 months
Periodo de tiempo: 6 months previous
Emergency Department (ED) attendances, Out Of Hours (OOH) contacts and hospital admissions during the last 6 months at baseline and 6 months for MISSION RAAC and primary care patients.
6 months previous
ED attendances at baseline
Periodo de tiempo: Baseline
Emergency Department (ED) attendances at baseline for MISSION RAAC and primary care patients.
Baseline
OOH contacts at baseline
Periodo de tiempo: Baseline
Out Of Hours (OOH) contacts at baseline for MISSION RAAC and primary care patients.
Baseline
Hospital admissions at baseline
Periodo de tiempo: Baseline
Hospital admissions at baseline for MISSION RAAC and primary care patients.
Baseline
ED attendances at 6 months.
Periodo de tiempo: 6 months
Emergency Department (ED) attendances at 6 months for MISSION RAAC and primary care patients.
6 months
Out Of Hours (OOH) contacts at 6 months
Periodo de tiempo: 6 months
Out Of Hours (OOH) contacts at 6 months for MISSION RAAC and primary care patients.
6 months
Hospital admissions during at 6 months
Periodo de tiempo: 6 months
Hospital admissions during at 6 months for MISSION RAAC and primary care patients.
6 months
Inhaled steroid doses and usage
Periodo de tiempo: 6 months
Inhaled steroid doses and usage for MISSION RAAC and primary care patients.
6 months
sensitivity and specificity of the Primary Care Information Services (PRIMIS) Asthma Audit Tool
Periodo de tiempo: 6 months
The sensitivity and specificity of the PRIMIS Asthma Audit Tool in identifying the patients compared to gold standard specialist assessment and interrogation of primary care records for MISSION RAAC and primary care patients.
6 months

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 junio de 2015

Finalización primaria (Actual)

1 de marzo de 2016

Finalización del estudio (Actual)

1 de marzo de 2016

Fechas de registro del estudio

Enviado por primera vez

13 de julio de 2015

Primero enviado que cumplió con los criterios de control de calidad

23 de julio de 2015

Publicado por primera vez (Estimar)

27 de julio 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

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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