Impact of a Nurse for Migraine Management: the IMPACT Project

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Notre-Dame Hospital, Montreal, Quebec, Canada
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Elizabeth Leroux, Notre-Dame Hospital, Montreal, Quebec, Canada
ClinicalTrials.gov Identifier:
NCT01804517
First received: February 23, 2013
Last updated: March 2, 2013
Last verified: March 2013
  Purpose

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.


Condition
Migraine Without Aura
Migraine With Aura
Chronic Migraine

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Impact of a Nursing Intervention on the Clinical Evolution of Patients at a University Migraine Clinic

Resource links provided by NLM:


Further study details as provided by Notre-Dame Hospital, Montreal, Quebec, Canada:

Primary Outcome Measures:
  • Hit-6 score change [ Time Frame: Baseline and 8 months ] [ Designated as safety issue: No ]
    HIT-6 score change between inclusion and 8 month.


Secondary Outcome Measures:
  • Frequency of moderate and severe headache days [ Time Frame: Baseline and 8 months ] [ Designated as safety issue: No ]
    Variation in the frequency of moderate or severe headache days per month between the first, fourth and eighth month after inclusion.

  • Frequency of headache days [ Time Frame: Baseline and 8 months ] [ Designated as safety issue: No ]
    Change in the frequency of headache days, all severity included, between the first month and the seventh and eight months following inclusion.

  • Chronic headache status [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: Yes ]
    Percent of patients who were chronic (more than 3 months with >15 headache days per month, retrospective) at entry and were episodic at one year (according to calendars).

  • Medication overuse [ Time Frame: Baseline and 8 months ] [ Designated as safety issue: No ]
    Percent of patients with medication overuse at entry and were not overusing anymore at 8 months.

  • Acute medication intake [ Time Frame: Baseline and 8 months ] [ Designated as safety issue: No ]
    Change in the number of days per month with acute medication use between the first month after inclusion and the seventh and eight months following inclusion.

  • Efficacy of acute treatment [ Time Frame: at 8 months ] [ Designated as safety issue: No ]
    Percent of patients who succeeded in finding a successful and properly used acute treatment at month eight, according to four criteria: efficacy, reliability, absence of recurrence, absence of significant side effects.

  • Response rate to prophylactics [ Time Frame: at 8 months ] [ Designated as safety issue: No ]
    Percent of patients who did complete a successful (>50% response and no significant side-effects) preventive treatment trial at month eight after inclusion.

  • Short Form 12 score [ Time Frame: Baseline and 8 months ] [ Designated as safety issue: No ]
    Change in SF-12 scores between inclusion and third visit. SF-12 is a quality of life questionnaire.

  • Visits to the emergency department [ Time Frame: over 1 year ] [ Designated as safety issue: No ]
    Number of headache-related emergency department visits per patient during the year following their inclusion.

  • Severe adverse effects from treatments [ Time Frame: over 1 year ] [ Designated as safety issue: Yes ]
    Percent of patients with a severe adverse effect from a treatment (necessitating hospitalization, emergency visit or specific treatment).

  • Phone calls returned [ Time Frame: per 1 month ] [ Designated as safety issue: No ]
    Number of phone calls returned per month

  • Patient satisfaction [ Time Frame: at 8 months ] [ Designated as safety issue: No ]
    Satisfaction of patients, evaluated by a customized questionnaire.

  • Phone call return delay [ Time Frame: for each phone call, mean ] [ Designated as safety issue: No ]
    Mean delay for returning the call (number of week days between the date of the call and the date of the return).

  • Global improvement [ Time Frame: at 8 months ] [ Designated as safety issue: No ]
    Evaluation of physician of the global improvement of the patient.


Estimated Enrollment: 200
Study Start Date: February 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Physician based approach
Patients will be managed as usual at the clinic without the intervention of the nurse.
Physician and nurse
Patients will be managed with the help of the nurse for education and follow-up.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients followed at the migraine clinic at the Notre-Dame Hospital in Montreal

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01804517

Contacts
Contact: Elizabeth Leroux, MD 514-890-8000 ext 26531 leroux.neuro@gmail.com
Contact: Melanie Bossé, B. Sc, DESS Pharmacy 514-890-8000 ext 25174 melanie.bosse.chum@ssss.gouv.qc.ca

Locations
Canada, Quebec
Hôpital Notre-Dame Recruiting
Montreal, Quebec, Canada, H2L 4M1
Contact: Elizabeth Leroux, M.D.    514-890-8000 ext 26531    leroux.neuro@gmail.com   
Contact: Melanie Bosse, B.Sc DESS    514-890-8000 ext 25174    melanie.bosse.chum@ssss.gouv.qc.ca   
Principal Investigator: Elizabeth Leroux, M.D.         
Sponsors and Collaborators
Notre-Dame Hospital, Montreal, Quebec, Canada
Allergan
Investigators
Principal Investigator: Elizabeth Leroux, M.D. FRCPC
  More Information

No publications provided

Responsible Party: Elizabeth Leroux, M.D. Neurologist, FRCPC, Notre-Dame Hospital, Montreal, Quebec, Canada
ClinicalTrials.gov Identifier: NCT01804517     History of Changes
Other Study ID Numbers: IMPACT
Study First Received: February 23, 2013
Last Updated: March 2, 2013
Health Authority: Canada: Public Health Agency of Canada

Keywords provided by Notre-Dame Hospital, Montreal, Quebec, Canada:
migraine

Additional relevant MeSH terms:
Migraine Disorders
Migraine with Aura
Migraine without Aura
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 31, 2014