Direct Access to MRI and Neurology Referrals for the Management of Patients With Chronic Headache.

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
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.

Conditions
-----------------
Chronic Headache

Intervention / Treatment
-----------------
* Other: MRI scan
* Other: Neurology Appointment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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).

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MRI scan<br>Direct referral from Primary Care (GPs) to an MRI scan as the initial Secondary Care point of contact. | Other: MRI scan<br>* MRI head scan to be performed as the first Secondary Care contact.<br>|
| Neurology Appointment<br>Referral from Primary Care (GPs) to Neurology Services in Secondary Care as the initial Secondary Care point of contact. | Other: Neurology Appointment<br>* Outpatient appointment with Neurologist as the first Secondary Care contact<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-month cost analysis per patient referred to either MRI or Neurology (measured in £ per patient) | 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. | 6 months after the initial episode at Secondary Care (either an MRI scan or Neurology Outpatient appointment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12-month cost analysis per patient referred to either MRI or Neurology (measured in £ per patient) | This secondary objective is aimed at evaluating whether direct access from General Practitioners (GPs) to Magnetic Resonance Imaging (MRI) for patients with chronic headache is associated with cost-savings at 12 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. | 12 months after the initial episode at Secondary Care (either an MRI scan or Neurology Outpatient appointment) | 
| 6-month cost-effectiveness analysis per patient referred to either MRI or Neurology (measured in £ per QALY) | This secondary objective is aimed at evaluating whether direct access from General Practitioners (GPs) to Magnetic Resonance Imaging (MRI) for patients with chronic headache is cost-effective 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. | 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) | This secondary objective is aimed at evaluating whether direct access from General Practitioners (GPs) to Magnetic Resonance Imaging (MRI) for patients with chronic headache is cost-effective at 12 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. | 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) | To evaluate and compare the levels of patient satisfaction associated with the two pathways: i) with direct access to MRI from Primary Care; and ii) with referral to the Neurology Department. A patient satisfaction questionnaire will be used to quantify patient satisfaction at 6 months. | 6 months | 
| Patient's self perceived quality of life - measured using EQ-5D-5L questionnaire | This objective aims to evaluate the patient's self-perceived quality of life associated with both pathways using a standard questionnaire (EQ-5D-5L). | 6 months | 
| Patient's self perceived quality of life - measured using HIT-6 questionnaire | This objective aims to evaluate the patient's self-perceived quality of life associated with both pathways using a standard headache-specific questionnaire (HIT-6 questionnaire). | 6 months | 
| Patient's self perceived quality of life - measured using MIDAS questionnaire | This objective aims to evaluate the patient's self-perceived quality of life associated with both pathways using a standard headache-specific questionnaire (MIDAS questionnaire). | 6 months | 
| Time-off work (measured in half days) due to chronic headache | To evaluate the headache burden and time-off work (both measured in half days) due to the chronic headache associated with the pathway with direct access to MRI compared with referral to the Neurology Department. | 12 months |