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

26 september 2016 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Astma

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Verenigd Koninkrijk
- Hampshire
  - Portsmouth, Hampshire, Verenigd Koninkrijk, PO6 3LY
    - Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Aantal groepen / cohorten

Cohorten en interventies

Groep / Cohort
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Asthma control as measured by exacerbation frequency for all patients Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Short acting bronchodilator (SABA) use Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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. Tijdsspanne: 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. Tijdsspanne: 6 months	Smoking cessation advice for MISSION SAAC patients and outpatient severe asthma clinic patients	6 months
Investigations performed in secondary care Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 6 months	Severity of co-morbidities for MISSION RAAC patients	6 months
Frequency of co-morbidities Tijdsspanne: 6 months	Frequency of co-morbidities for MISSION RAAC patients	6 months
Frequency & type of allergy Tijdsspanne: 6 months	Frequency & type of allergy for MISSION RAAC patients	6 months
Measurement of exhaled nitric oxide Tijdsspanne: 6 months	Measurement of exhaled nitric oxide for MISSION RAAC patients	6 months
Measurement & variation of lung function (Single Tijdsspanne: 6 months	Composite measurement & variation of lung function for MISSION RAAC patients	6 months
Frequency and type of additional asthma control medication. Tijdsspanne: 6 months	Frequency and type of additional asthma control medication for MISSION RAAC patients	6 months
Quality of life Tijdsspanne: 6 months	Quality of life as assessed by the Asthma Quality of Life Questionnaire (AQLQ).	6 months
Disease control Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: Baseline	Emergency Department (ED) attendances at baseline for MISSION RAAC and primary care patients.	Baseline
OOH contacts at baseline Tijdsspanne: Baseline	Out Of Hours (OOH) contacts at baseline for MISSION RAAC and primary care patients.	Baseline
Hospital admissions at baseline Tijdsspanne: Baseline	Hospital admissions at baseline for MISSION RAAC and primary care patients.	Baseline
ED attendances at 6 months. Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 6 months	Hospital admissions during at 6 months for MISSION RAAC and primary care patients.	6 months
Inhaled steroid doses and usage Tijdsspanne: 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 Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Portsmouth Hospitals NHS Trust

Medewerkers

University of Portsmouth

Onderzoekers

Hoofdonderzoeker: Professor Anoop J Chauhan, Portsmouth Hospitals NHS Trust

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juni 2015

Primaire voltooiing (Werkelijk)

1 maart 2016

Studie voltooiing (Werkelijk)

1 maart 2016

Studieregistratiedata

Eerst ingediend

13 juli 2015

Eerst ingediend dat voldeed aan de QC-criteria

23 juli 2015

Eerst geplaatst (Schatting)

27 juli 2015

Updates van studierecords

Laatste update geplaatst (Schatting)

27 september 2016

Laatste update ingediend die voldeed aan QC-criteria

26 september 2016

Laatst geverifieerd

1 september 2016

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

PHT/2015/15

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