Clinical trial NCT01804517: Impact of a Nurse for Migraine Management: the IMPACT Project
Official title: Impact of a Nursing Intervention on the Clinical Evolution of Patients at a University Migraine Clinic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine Without Aura
Migraine With Aura
Chronic Migraine
Keywords: migraine
Lead sponsor: Notre-Dame Hospital, Montreal, Quebec, Canada
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2013-03-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients followed at the migraine clinic at the Notre-Dame Hospital in Montreal

Brief summary: Headache disorders are prevalent, disabling, under recognized, under diagnosed and under treated. Migraine has a prevalence of 10% in men and 25% in women in Canada. The treatment of migraine is based on patient education (lifestyle habit modification, trigger avoidance), and pharmacological acute treatment and prophylaxis. A multidisciplinary approach allows a repartition of tasks between different health professionals.

In a 2010 meeting, the Canadian Headache Society members supported the concept of Headache Centers, and a headache nurse was judged as an essential component of such centers.

Gaul has reviewed the structured multidisciplinary approach that could be used in a headache centre and the existing studies using such structures. Five studies did include a headache nurse. No study did observe the impact of a nurse only. Resources in medical care are limited. One study did use a program of 96 hours, which does not seem realistic on the long-term and for a large pool of patients in a public hospital. Patients are not always able to pay for paramedical help such as physiotherapy and psychotherapy. Even if they do, finding a specialized therapist for chronic headache is difficult. Defining the role of a nurse and demonstrating the impact on patient care is therefore a first step in the concept of a headache center. Possible roles of a headache nurse according to Gaul are patient education, follow-up of the treatment plan, addressing patient queries, and monitoring of patient progress. The headache nurse may also participate in research projects. In a hospital Headache Clinic, the nurse may be involved in intra-venous treatments and blood sampling for research.

In summary, evidence to demonstrate the impact of a nurse in a headache clinic is lacking. We propose to study this aspect prospectively. A study with positive findings would encourage health ministers to fund and support headache nurses for headache centers across Canada for headache management. Chronic headache and therefore chronic migraine would be a focus of such centers, since most patients seen in specialized centers are chronic.

HYPOTHESIS: The addition of a headache nurse to the headache team will help the CHUM Migraine Clinic to improve treatment outcome, and reduce the burden of headache. This multidisciplinary approach will also allow a higher efficiency of the team.

Detailed description: STUDY DESIGN:

The goal of this study is to compare two treatment approaches for migraineurs. The first approach will be based on the physician only and is limited to fixed appointments (control group). The second approach will be based on a team involving a headache nurse (active group) who will participate in patient education and follow-up. The goal is to improve patient outcome but also physician productivity.

First 100 patients (control group, phase 1): patients with episodic and chronic migraine will be screened, sign consent and be enrolled. They will be seen by the physician only, without the nurse's support. This situation will reproduce the actual conditions at the clinic. During this phase, the nurse will be involved in the follow-up of known patients (who will not be included in the protocol) and data collection. She will develop her headache management abilities and help the physicians to develop some educational tools for patients.

Following 100 patients (active group, phase 2) : patients with episodic and chronic migraine will be screened and enroled. They will be seen by the physician and nurse team, with a treatment plan tailored to specific needs including regular scheduled visits, follow-up of chronification factors and educational sessions. Phone call follow-ups will be planned. Patients will have an easier and quicker contact with the team in an emergency situation.

Eligibility criteria: INCLUSION CRITERIA:

* Age 18 or more
* Diagnosis of migraine, chronic or episodic, at the first visit. We expect the majority of patients to suffer form frequent or chronic migraine.
* Consent to participate in the CHUM Migraine Clinic IMPACT project.
* For future post-hoc analysis, groups will be stratified according to baseline headache frequency (all severity included), assessed retrospectively at the first visit:

  * \<6 headache days per month,
  * 6 to 14 headache days per month
  * 15 or more headache days per month

EXCLUSION CRITERIA:

* Patients whom first headache diagnosis is not migraine (for example post-traumatic headache, cluster headache, trigeminal neuralgia, facial pain).
* Women with ongoing or planned pregnancy.
* Patient with an active psychiatric condition (needing hospitalisation or psychosis).
* Patient with mental retardation impairing assessment or follow-up.
* Patient with an active medical condition which may lead to frequent hospitalisations (eg active cancer, organ graft, hemodialysis etc). This will be determined and detailed by the evaluating physician.
* Active drug addiction or alcoholism.
* Active follow-up at a pain clinic.
* Patient speaking a language other than french and incapable to communicate in a reliable way.

Primary outcomes:
measure: Hit-6 score change
timeFrame: Baseline and 8 months
Secondary outcomes:
measure: Frequency of moderate and severe headache days
timeFrame: Baseline and 8 months
measure: Frequency of headache days
timeFrame: Baseline and 8 months
measure: Chronic headache status
timeFrame: Baseline and 1 year
measure: Medication overuse
timeFrame: Baseline and 8 months
measure: Acute medication intake
timeFrame: Baseline and 8 months
measure: Efficacy of acute treatment
timeFrame: at 8 months
measure: Response rate to prophylactics
timeFrame: at 8 months
measure: Short Form 12 score
timeFrame: Baseline and 8 months
measure: Visits to the emergency department
timeFrame: over 1 year
measure: Severe adverse effects from treatments
timeFrame: over 1 year
measure: Phone calls returned
timeFrame: per 1 month
measure: Patient satisfaction
timeFrame: at 8 months
measure: Phone call return delay
timeFrame: for each phone call, mean
measure: Global improvement
timeFrame: at 8 months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Hôpital Notre-Dame
state: Quebec
Study officials:
affiliation: FRCPC
name: Elizabeth Leroux, M.D.
role: PRINCIPAL_INVESTIGATOR
References: