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

2016년 9월 26일 업데이트: 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.

연구 개요

상태

완전한

정황

상세 설명

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.

연구 유형

관찰

등록 (실제)

92

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

모두

샘플링 방법

확률 샘플

연구 인구

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.

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Asthma control as measured by exacerbation frequency for all patients
기간: 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

2차 결과 측정

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Professor Anoop J Chauhan, Portsmouth Hospitals NHS Trust

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2015년 6월 1일

기본 완료 (실제)

2016년 3월 1일

연구 완료 (실제)

2016년 3월 1일

연구 등록 날짜

최초 제출

2015년 7월 13일

QC 기준을 충족하는 최초 제출

2015년 7월 23일

처음 게시됨 (추정)

2015년 7월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2016년 9월 27일

QC 기준을 충족하는 마지막 업데이트 제출

2016년 9월 26일

마지막으로 확인됨

2016년 9월 1일

추가 정보

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