An Observational Study to Evaluate Referral From General Practitioners (GPs) to: 1) Direct Access to Magnetic Resonance Imaging (MRI); and 2) the Neurology Department for the Management of Patients With Chronic Headache.
试验速览
- 阶段
- 不适用
- 入组人数
- 296
- 试验地点
- 1
- 主要终点
- 6-month cost analysis per patient referred to either MRI or Neurology (measured in £ per patient)
研究概览
简要总结
This study aims to evaluate whether direct access from General Practitioners (GPs) to Magnetic Resonance Imaging (MRI) for patients with chronic headache decreases overall NHS costs and increases patient satisfaction compared to clinical practice with referral to Neurology Services.
详细描述
Headache is the most common symptom reported in the community, affecting more than 90% of the population at some point in their lifetime. Despite the low level of referrals to secondary care (as most patients tend to be managed within primary care), the absolute number of headache episodes (due to its high prevalence) makes headache the most frequently listed reason for referral to the Neurologist and thus, utilises precious capacity that is severely constrained.
In order to support future management of this chronic condition, this study aims to evaluate existing clinical pathways in the management of patients with chronic headache - either referral to the Neurology Department or direct access to Imaging. Participants will be followed-up for a period of 12 months after the initial Secondary Care episode (either an MRI scan or Neurology appointment). Costs from the NHS perspective and self-perceived patient quality of life will be assessed and cost per patient and cost-effectiveness analyses will be performed.
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
- 否
入选标准
- •Every patient aged 16 years or over with: i) chronic headache as a primary cause that has lasted ≥ 15 days per month for more than 3 months; and ii) referred from GP practices to GSTT, either directly referred to an MRI exam or a Neurology outpatient appointment.
排除标准
- •Children under the age of 16;
- •Patients with red flags as defined in NICE guideline CG150;
- •Patients without chronic primary headache, i.e. a headache that has not persisted for ≥ 15 days per month for more than 3 months
- •Patients with headache referred through the two week wait list;
- •Patients who lack capacity to give consent or participate in the study;
- •Patients not fluent in English;
- •Prisoners;
- •Patients that are already taking part in a clinical trial of an investigational medicinal products (CTIMPs).
结局指标
主要结局
6-month cost analysis per patient referred to either MRI or Neurology (measured in £ per patient)
时间窗: 6 months after the initial episode at Secondary Care (either an MRI scan or Neurology Outpatient appointment)
The primary objective is to evaluate whether direct access from General Practitioners (GPs) to Magnetic Resonance Imaging (MRI) for patients with chronic headache is associated with cost-savings at 6 months after the initial episode at Secondary Care (either an MRI scan or a Neurology Outpatient appointment) compared to clinical practice with referral to the Neurology Department.
次要结局
- 12-month cost analysis per patient referred to either MRI or Neurology (measured in £ per patient)(12 months after the initial episode at Secondary Care (either an MRI scan or Neurology Outpatient appointment))
- Patient's self perceived quality of life - measured using MIDAS questionnaire(6 months)
- Patient's self perceived quality of life - measured using HIT-6 questionnaire(6 months)
- 6-month cost-effectiveness analysis per patient referred to either MRI or Neurology (measured in £ per QALY)(6 months after the initial episode at Secondary Care (either an MRI scan or Neurology Outpatient appointment))
- 12-month cost-effectiveness analysis per patient referred to either MRI or Neurology (measured in £ per QALY)(12 months after the initial episode at Secondary Care (either an MRI scan or Neurology Outpatient appointment))
- Patient satisfaction associated with both clinical pathways (direct referral to MRI or Neurology)(6 months)
- Patient's self perceived quality of life - measured using EQ-5D-5L questionnaire(6 months)
- Time-off work (measured in half days) due to chronic headache(12 months)