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临床试验/NCT03096509
NCT03096509已完成不适用

MISSION ABC: Modern Innovative Solutions to Improve Outcomes in Asthma, Breathlessness and COPD - Participatory Action Research to Evaluate the Delivery of the MISSION ABC Service Model and Assess Health Service and Clinical Outcomes

Portsmouth Hospitals NHS Trust1 个研究点 分布在 1 个国家目标入组 342 人开始时间: 2017年1月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
342
试验地点
1
主要终点
Acceptability of clinic process measured through the collection of qualitative feedback.

研究概览

简要总结

Innovations aimed at improving new patient identification, diagnosis, nonpharmacological treatment, supported self-management, and remote monitoring, together with new methods of clinical support could improve outcomes in patients with respiratory disease. The Investigators have developed a model of care incorporating key innovations for patients with asthma, COPD and undifferentiated breathlessness. This service is being implemented within Wessex CCGs. The investigators will assess whether the implementation of the service is effective, and how it can be adjusted, in addition to introducing innovations to assess whether the expected benefits for patients are realised.

详细描述

A combination of study designs are required to evaluate all aspects of the service:

  • Participatory action research approach, involving real-time evaluation at each clinic to inform subsequent clinics
  • Before-and-after study for patient outcomes pre-clinic attendance and post-clinic attendance.
  • Qualitative methods (interviews, focus groups)

Evaluation of the clinic cycles will include consideration of qualitative data from patients, carers and healthcare professionals, in addition to quantitative outcomes for service implementation and patient factors (i.e. uptake of the service and benefits realised in-session), including those in the following areas:

  • Clinic process
  • Education and supported self-management
  • Added value of diagnostic tools (new diagnoses)
  • Applicability and use of treatment tools and treatment tailoring
  • Self-monitoring appropriateness and uptake
  • Balance measures (e.g. increased secondary care traffic)

The longer-term impact of the service will be evaluated using clinical and health service outcomes such as:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Attendance at a MISSION ABC clinic or training session as a patient, carer or Healthcare Professional

排除标准

  • Unable to give informed consent
  • Level of literacy precludes inclusion in questionnaire-based study

结局指标

主要结局

Acceptability of clinic process measured through the collection of qualitative feedback.

时间窗: up to 18 months

Qualitative feedback forms collected at ever clinical encounter, qualitative interviews at 3 months post clinic and HCP focus groups will generate qualitative data. This will be evaluated cyclically to inform changes in the clinic structure.

次要结局

  • Number of changes in primary diagnosis or classification of disease severity resulting from a MISSION clinic appointment.(18 months)
  • Acceptability of each innovation measured(18 months)
  • Number of additional co-morbid medical conditions identified from a MISSION clinical encounter.(18 months)
  • Frequency of uptake and attendance at the enhanced asthma education programme ESMENA(18 months)
  • Changes in patients' perceived confidence in self-management before and after MISSION clinics and education sessions measured through questionnaire feedback(18 months)
  • Uptake and acceptability of HCP education through the MISSION process(18 months)
  • Number of patients where inhaler technique is improved at the first MISSION clinical encounter(18 months)
  • Number of referrals to the smoking cessation service embedded in the MISSION clinics that results in a quit attempt(18 months)
  • Any change in medication recorded(18 months)
  • Number of triggers on remote monitoring that can be managed remotely(18 months)
  • Number of additional secondary care referrals made as a result of the MISSION ABC process.(18 months)
  • Change in disease-specific symptom control questionnaires from baseline to 3 and 6 months(6 months)
  • Change in the productivity measure WPA from baseline to 3 and 6 months(6 months)
  • Change in the patient activation measure from baseline to 3 and 6 months.(6 months)
  • Changes in unscheduled health care usage per patient in the 12 months before and after MISSION ABC(24 months)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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