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

This study is currently recruiting participants.
Verified August 2017 by Guy's and St Thomas' NHS Foundation Trust
Sponsor:
ClinicalTrials.gov Identifier:
NCT02753933
First Posted: April 28, 2016
Last Update Posted: August 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
King's College London
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust
  Purpose
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.

Condition Intervention
Chronic Headache Other: MRI scan Other: Neurology Appointment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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.

Resource links provided by NLM:


Further study details as provided by Guy's and St Thomas' NHS Foundation Trust:

Primary Outcome Measures:
  • 6-month cost analysis per patient referred to either MRI or Neurology (measured in £ per patient) [ Time Frame: 6 months after the initial episode at Secondary Care (either an MRI scan or Neurology Outpatient appointment) ]
    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.


Secondary Outcome Measures:
  • 12-month cost analysis per patient referred to either MRI or Neurology (measured in £ per patient) [ Time Frame: 12 months after the initial episode at Secondary Care (either an MRI scan or Neurology Outpatient appointment) ]
    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.

  • 6-month cost-effectiveness analysis per patient referred to either MRI or Neurology (measured in £ per QALY) [ Time Frame: 6 months after the initial episode at Secondary Care (either an MRI scan or Neurology Outpatient appointment) ]
    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.

  • 12-month cost-effectiveness analysis per patient referred to either MRI or Neurology (measured in £ per QALY) [ Time Frame: 12 months after the initial episode at Secondary Care (either an MRI scan or Neurology Outpatient appointment) ]
    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.

  • Patient satisfaction associated with both clinical pathways (direct referral to MRI or Neurology) [ Time Frame: 6 months ]
    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.

  • Patient's self perceived quality of life - measured using EQ-5D-5L questionnaire [ Time Frame: 6 months ]
    This objective aims to evaluate the patient's self-perceived quality of life associated with both pathways using a standard questionnaire (EQ-5D-5L).

  • Patient's self perceived quality of life - measured using HIT-6 questionnaire [ Time Frame: 6 months ]
    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).

  • Patient's self perceived quality of life - measured using MIDAS questionnaire [ Time Frame: 6 months ]
    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).

  • Time-off work (measured in half days) due to chronic headache [ Time Frame: 12 months ]
    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.


Estimated Enrollment: 296
Actual Study Start Date: April 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02753933


Contacts
Contact: Yvonne Akande, Master yvonne.akande@kcl.ac.uk

Locations
United Kingdom
Guy's and St Thomas' NHS Foundation Trust Recruiting
London, United Kingdom, SE1 7EH
Contact: Yvonne Akande       yvonne.akande@kcl.ac.uk   
Contact: Tiago Rua       tiago.rua@kcl.ac.uk   
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
King's College London
Investigators
Principal Investigator: Asif Mazumder, MD Guy's & St Thomas' Hospitals NHS Foundation Trust
  More Information

Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02753933     History of Changes
Other Study ID Numbers: MRI headache v2.0
First Submitted: April 25, 2016
First Posted: April 28, 2016
Last Update Posted: August 8, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Headache
Headache Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases