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

NCT ID: NCT02753933

Last Updated: 2017-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

296 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Chronic Headache

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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MRI scan

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

MRI scan

Intervention Type OTHER

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.

Neurology Appointment

Intervention Type OTHER

Outpatient appointment with Neurologist as the first Secondary Care contact

Interventions

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MRI scan

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

Intervention Type OTHER

Neurology Appointment

Outpatient appointment with Neurologist as the first Secondary Care contact

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King's College London

OTHER

Sponsor Role collaborator

Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Asif Mazumder, MD

Role: PRINCIPAL_INVESTIGATOR

Guy's and St Thomas' NHS Foundation Trust

Locations

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Guy's and St Thomas' NHS Foundation Trust

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Yvonne Akande, Master

Role: CONTACT

Facility Contacts

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Yvonne Akande

Role: primary

Tiago Rua

Role: backup

References

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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.

Reference Type DERIVED
PMID: 33067273 (View on PubMed)

Other Identifiers

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MRI headache v2.0

Identifier Type: -

Identifier Source: org_study_id

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