Clinical trial NCT02753933: Direct Access to MRI and Neurology Referrals for the Management of Patients With Chronic Headache.
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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Headache
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: King's College London
First posted: 2016-04-28
Enrollment: 296
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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).

Primary outcomes:
measure: 6-month cost analysis per patient referred to either MRI or Neurology (measured in £ per patient)
timeFrame: 6 months after the initial episode at Secondary Care (either an MRI scan or Neurology Outpatient appointment)
Secondary outcomes:
measure: 12-month cost analysis per patient referred to either MRI or Neurology (measured in £ per patient)
timeFrame: 12 months after the initial episode at Secondary Care (either an MRI scan or Neurology Outpatient appointment)
measure: 6-month cost-effectiveness analysis per patient referred to either MRI or Neurology (measured in £ per QALY)
timeFrame: 6 months after the initial episode at Secondary Care (either an MRI scan or Neurology Outpatient appointment)
measure: 12-month cost-effectiveness analysis per patient referred to either MRI or Neurology (measured in £ per QALY)
timeFrame: 12 months after the initial episode at Secondary Care (either an MRI scan or Neurology Outpatient appointment)
measure: Patient satisfaction associated with both clinical pathways (direct referral to MRI or Neurology)
timeFrame: 6 months
measure: Patient's self perceived quality of life - measured using EQ-5D-5L questionnaire
timeFrame: 6 months
measure: Patient's self perceived quality of life - measured using HIT-6 questionnaire
timeFrame: 6 months
measure: Patient's self perceived quality of life - measured using MIDAS questionnaire
timeFrame: 6 months
measure: Time-off work (measured in half days) due to chronic headache
timeFrame: 12 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
Study officials:
affiliation: Guy's and St Thomas' NHS Foundation Trust
name: Asif Mazumder, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.