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

Chronic Headache Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02753933
• Other study ID #: MRI headache v2.0
• Status: Recruiting
• Phase: N/A
• First received: April 25, 2016
• Last updated: August 7, 2017
• Start date: April 2016
• Est. completion date: December 2018

Study information

• Verified date: August 2017
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: Yvonne Akande, Master
• Email: yvonne.akande[@]kcl.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 296
• Est. completion date: December 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Headache
• Headache
• Headache Disorders

Intervention

Other:
• MRI scan
MRI head scan to be performed as the first Secondary Care contact.
• Neurology Appointment
Outpatient appointment with Neurologist as the first Secondary Care contact

Locations

Country	Name	City	State
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust	King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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