Impact of a Nurse for Migraine Management: the IMPACT Project (IMPACT)
|ClinicalTrials.gov Identifier: NCT01804517|
Recruitment Status : Completed
First Posted : March 5, 2013
Last Update Posted : December 8, 2016
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 or disease|
|Migraine Without Aura Migraine With Aura Chronic Migraine|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||200 participants|
|Observational Model:||Case Control|
|Target Follow-Up Duration:||1 Year|
|Official Title:||Impact of a Nursing Intervention on the Clinical Evolution of Patients at a University Migraine Clinic|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
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.
- Hit-6 score change [ Time Frame: Baseline and 8 months ]HIT-6 score change between inclusion and 8 month.
- Frequency of moderate and severe headache days [ Time Frame: Baseline and 8 months ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]Number of phone calls returned per month
- Patient satisfaction [ Time Frame: at 8 months ]Satisfaction of patients, evaluated by a customized questionnaire.
- Phone call return delay [ Time Frame: for each phone call, mean ]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 ]Evaluation of physician of the global improvement of the patient.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01804517
|Montreal, Quebec, Canada, H2L 4M1|
|Principal Investigator:||Elizabeth Leroux, M.D.||FRCPC|