Chronic HeadacheNCT02753933
Direct Access to MRI and Neurology Referrals for the Management of Patients With Chronic Headache.
An observational study of Chronic Headache, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Chronic Headache
- What is being tested?
- MRI scan and Neurology Appointment
- How many people
- 296 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2016to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with chronic headache referred from Primary Care to Secondary Care to either an MRI scan or a Neurology outpatient appointment.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Yvonne Akande, Master contact
United Kingdom1 site, 1 recruiting
- Recruiting
Guy's and St Thomas' NHS Foundation Trust
London, SE1 7EH
Yvonne Akande, yvonne.akande@kcl.ac.uk
Tiago Rua, tiago.rua@kcl.ac.uk
About this study
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.
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.
Read the 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.
- Conditions
- Chronic Headache
- Being tested
- MRI scan, Neurology Appointment
- Medical subject headings
- Headache Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI scanOther
MRI head scan to be performed as the first Secondary Care contact.
Neurology AppointmentOther
Outpatient appointment with Neurologist as the first Secondary Care contact
| Study group | Role | What they receive |
|---|---|---|
| MRI scan | Direct referral from Primary Care (GPs) to an MRI scan as the initial Secondary Care point of contact. Receives: Other: MRI scan | |
| Neurology Appointment | Referral from Primary Care (GPs) to Neurology Services in Secondary Care as the initial Secondary Care point of contact. Receives: Other: Neurology Appointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionJun 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic HeadacheStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 296 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
- Investigators
- Asif Mazumder, MD, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02753933
- Sponsor's protocol ID
- MRI headache v2.0
- Status last verified
- Aug 2017
- First submitted
- 25 Apr 2016
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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.
PubMed 33067273
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02753933
- Acronym / sponsor ID
- MRI headache v2.0
- Conditions
- Chronic Headache
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 296 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- Apr 2016 (actual)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 28 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRI scan | – | Other: MRI scanDirect referral from Primary Care (GPs) to an MRI scan as the initial Secondary Care point of contact. |
| Neurology Appointment | – | Other: Neurology AppointmentReferral from Primary Care (GPs) to Neurology Services in Secondary Care as the initial Secondary Care point of contact. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with chronic headache referred from Primary Care to Secondary Care to either an MRI scan or a Neurology outpatient appointment.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI scanMRI head scan to be performed as the first Secondary Care contact. | Other | MRI scan |
| Neurology AppointmentOutpatient appointment with Neurologist as the first Secondary Care contact | Other | Neurology Appointment |
Primary outcome
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.
8 secondary outcomes
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)
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)
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)
Patient satisfaction associated with both clinical pathways (direct referral to MRI or Neurology)
Time frame: 6 months
Patient's self perceived quality of life - measured using EQ-5D-5L questionnaire
Time frame: 6 months
Patient's self perceived quality of life - measured using HIT-6 questionnaire
Time frame: 6 months
Patient's self perceived quality of life - measured using MIDAS questionnaire
Time frame: 6 months
Time-off work (measured in half days) due to chronic headache
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2017.
- Derived from this study: PubMed 33067273Rua 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yvonne Akande, Master contact
Asif Mazumder, MD principal investigator
Guy's and St Thomas' NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Headache, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yvonne Akande, Master (yvonne.akande@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02753933, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2017.