Impact of a Nursing Intervention on the Clinical Evolution of Patients at a University Migraine Clinic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Hit-6 score change
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Hit-6 score change
时间窗: Baseline and 8 months
HIT-6 score change between inclusion and 8 month.
次要结局
- Frequency of headache days(Baseline and 8 months)
- Chronic headache status(Baseline and 1 year)
- Medication overuse(Baseline and 8 months)
- Acute medication intake(Baseline and 8 months)
- Efficacy of acute treatment(at 8 months)
- Response rate to prophylactics(at 8 months)
- Short Form 12 score(Baseline and 8 months)
- Visits to the emergency department(over 1 year)
- Severe adverse effects from treatments(over 1 year)
- Phone calls returned(per 1 month)
- Frequency of moderate and severe headache days(Baseline and 8 months)
- Patient satisfaction(at 8 months)
- Phone call return delay(for each phone call, mean)
- Global improvement(at 8 months)
研究者
Elizabeth Leroux
M.D. Neurologist, FRCPC
Notre-Dame Hospital, Montreal, Quebec, Canada