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

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.

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Headache
• Intervention / Treatment: Other: MRI scan; Other: Neurology Appointment

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.

• Study Type: Observational
• Enrollment (Anticipated): 296

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 7EH
    • Recruiting
    • Guy's and St Thomas' NHS Foundation Trust
    • Contact: Yvonne Akande; Email: yvonne.akande@kcl.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic headache referred from Primary Care to Secondary Care to either an MRI scan or a Neurology outpatient appointment.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MRI scan; Direct referral from Primary Care (GPs) to an MRI scan as the initial Secondary Care point of contact.	Other: MRI scan; MRI head scan to be performed as the first Secondary Care contact.
Neurology Appointment; Referral from Primary Care (GPs) to Neurology Services in Secondary Care as the initial Secondary Care point of contact.	Other: Neurology Appointment; Outpatient appointment with Neurologist as the first Secondary Care contact

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

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Collaborators: King's College London
• Investigators: Principal Investigator: Asif Mazumder, MD, Guy's and St Thomas' NHS Foundation Trust

Publications and helpful links

General Publications

• Rua T, Mazumder A, Akande Y, Margariti C, Ochulor J, Turville J, Razavi R, Peacock JL, McCrone P, Goh V, Shearer J, Afridi S. Management of chronic headache with referral from primary care to direct access to MRI compared with Neurology services: an observational prospective study in London. BMJ Open. 2020 Oct 16;10(10):e036097. doi: 10.1136/bmjopen-2019-036097.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: April 25, 2016
• First Submitted That Met QC Criteria: April 25, 2016
• First Posted (Estimate): April 28, 2016

Study Record Updates

• Last Update Posted (Actual): August 8, 2017
• Last Update Submitted That Met QC Criteria: August 7, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache; Headache Disorders
• Other Study ID Numbers: MRI headache v2.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO