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

NCT02753933 | Unknown DMC

• 1 other identifier: MRI headache v2.0
• Study Type: observational
• Target: 296
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Headache

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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)

• 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

Study Arms (2)

MRI scan

Direct referral from Primary Care (GPs) to an MRI scan as the initial Secondary Care point of contact.

Other: MRI scan

Neurology Appointment

Referral from Primary Care (GPs) to Neurology Services in Secondary Care as the initial Secondary Care point of contact.

Other: Neurology Appointment

Interventions

MRI scan OTHER

MRI head scan to be performed as the first Secondary Care contact.

MRI scan

Neurology Appointment OTHER

Outpatient appointment with Neurologist as the first Secondary Care contact

Neurology Appointment

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• King's College London: collaborator

Study Sites (1)

Guy's and St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 33067273 DERIVED

MeSH Terms

Conditions

Headache Disorders

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Asif Mazumder, MD

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yvonne Akande, Master

CONTACT

yvonne.akande@kcl.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: April 28, 2016
• Study Start: April 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: August 8, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)