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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Asthma control as measured by exacerbation frequency for all patients
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •The patient is unable or unwilling to give consent
结局指标
主要结局
Asthma control as measured by exacerbation frequency for all patients
时间窗: 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
次要结局
- Assessment of co-morbidity(6 months)
- Assessment of inhaler technique and recommendations for inhaler devices.(6 months)
- Smoking cessation advice.(6 months)
- Investigations performed in secondary care(6 months)
- Short acting bronchodilator (SABA) use(6 months)
- Exacerbation frequency(6 months)
- Health care usage costs for asthma and number of contacts(6 months)
- Time from GP referral to 1st clinic visit(6 months)
- Time between 1st and 2nd visit(6 months)
- Time to appointment with other specialists(6 months)
- Fractional Exhaled Nitric Oxide (FeNO) Assessment(6 months)
- Frequency of non-attendance(6 months)
- Severity of co-morbidities(6 months)
- Frequency and type of additional asthma control medication.(6 months)
- Quality of life(6 months)
- Disease control(6 months)
- Number of Forced Expiratory Volume at one second (FEV1) / Forced Vital Capacity (FVC) measurements(6 months)
- Prescription of SABA's(6 months)
- Exacerbation rates(6 months)
- Frequency of co-morbidities(6 months)
- Frequency & type of allergy(6 months)
- Measurement of exhaled nitric oxide(6 months)
- Measurement & variation of lung function (Single(6 months)
- ED attendances during the last 6 months(6 months previous)
- Out Of Hours (OOH) contacts during the last 6 months(6 months previous)
- OOH contacts at baseline(Baseline)
- Hospital admissions at baseline(Baseline)
- ED attendances at 6 months.(6 months)
- Hospital admissions during the last 6 months(6 months previous)
- ED attendances at baseline(Baseline)
- Out Of Hours (OOH) contacts at 6 months(6 months)
- Hospital admissions during at 6 months(6 months)
- Inhaled steroid doses and usage(6 months)
- sensitivity and specificity of the Primary Care Information Services (PRIMIS) Asthma Audit Tool(6 months)