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A proactive approach to migraine in primary care: a pragmatic randomized controlled trial.

ABSTRACT: BACKGROUND: Migraine is a common, disabling headache disorder that leads to lost quality of life and productivity. We investigated whether a proactive approach to patients with migraine, including an educational intervention for general practitioners, led to a decrease in headache and associated costs. METHODS: We conducted a pragmatic randomized controlled trial. Participants were randomized to one of two groups: practices receiving the intervention and control practices. Participants were prescribed two or more doses of triptan per month. General practitioners in the intervention group received training on treating migraine and invited participating patients for a consultation and evaluation of the therapy they were receiving. Physicians in the control group continued with usual care. Our primary outcome was patients' scores on the Headache Impact Test (HIT-6) at six months. We considered a reduction in score of 2.3 points to be clinically relevant. We used the Kessler Psychological Distress Scale (K10) questionnaire to determine if such distress was a possible effect modifier. We also examined the interventions' cost-effectiveness. RESULTS: We enrolled 490 patients in the trial (233 to the intervention group and 257 to the control group). Of the 233 patients in the intervention group, 192 (82.4%) attended the consultation to evaluate the treatment of their migraines. Of these patients, 43 (22.3%) started prophylaxis. The difference in change in score on the HIT-6 between the intervention and control groups was 0.81 (p = 0.07, calculated from modelling using generalized estimating equations). For patients with low levels of psychological distress (baseline score on the K10 ? 20) this change was -1.51 (p = 0.008), compared with a change of 0.16 (p = 0.494) for patients with greater psychological distress. For patients who were not using prophylaxis at baseline and had two or more migraines per month, the mean HIT-6 score improved by 1.37 points compared with controls (p = 0.04). We did not find the intervention to be cost-effective. INTERPRETATION: An educational intervention for general practitioners and a proactive approach to patients with migraine did not result in a clinically relevant improvement of symptoms. Psychological distress was an important confounder of success. (Current Controlled Trials registration no. ISRCTN72421511.).

SUBMITTER: Smelt AF

PROVIDER: S-EPMC3291695 | biostudies-literature | 2012 Mar

REPOSITORIES: biostudies-literature

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A proactive approach to migraine in primary care: a pragmatic randomized controlled trial.

Smelt Antonia F H AF Blom Jeanet W JW Dekker Frans F van den Akker M Elske ME Knuistingh Neven Arie A Zitman Frans G FG Ferrari Michel D MD Assendelft Pim P

CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne 20120109 4

<h4>Background</h4>Migraine is a common, disabling headache disorder that leads to lost quality of life and productivity. We investigated whether a proactive approach to patients with migraine, including an educational intervention for general practitioners, led to a decrease in headache and associated costs.<h4>Methods</h4>We conducted a pragmatic randomized controlled trial. Participants were randomized to one of two groups: practices receiving the intervention and control practices. Participa ...[more]

PMID: 22231680

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Project description:BACKGROUND:Chronic disease prevention and management programs are usually single-disease oriented. Our objective was to evaluate an intervention that targeted multiple chronic conditions and risk factors. METHODS:We conducted a pragmatic randomized controlled trial involving patients aged 18-75 years with at least 1 of the targeted chronic conditions or risk factors from 8 primary care practices in the Saguenay region of Quebec, Canada, to evaluate an intervention that included self-management support and patient-centred motivational approaches. Self-management (primary outcome) was evaluated using the Health Education Impact Questionnaire (heiQ). Secondary outcomes included self-efficacy, health-related quality of life, psychological distress and health behaviours. RESULTS:Three hundred thirty-two patients were recruited and randomly assigned (n = 166 for both intervention and control groups) and evaluated after 3 months. The intervention group showed improvement in 6 of the 8 heiQ domains: health-directed behaviour (relative risk [RR] 1.71, 95% confidence interval [CI] 1.13 to 2.59), emotional well-being (RR 1.73, 95% CI 1.07 to 2.79), self-monitoring and insight (RR 2.40, 95% CI 1.19 to 4.86), constructive attitudes and approaches (RR 2.40, 95% CI 1.37 to 4.21), skill and technique acquisition (RR 1.70, 95% CI 1.14 to 2.53), and health service navigation (RR 1.93, 95% CI 1.08 to 3.47). Improvement was also observed in the Physical Component Summary (p = 0.017) and the Single Index (p = 0.041) of the 12-Item Short Form Health Survey (version 2). The intervention group improved in fruit and vegetable consumption (odds ratio [OR] 2.36, 95% CI 1.41 to 3.95) and physical activity (OR 3.81, 95% CI 1.65 to 8.76). One-year improvement was maintained in the intervention group for several outcomes. INTERPRETATION:It is possible to implement an intervention integrating chronic disease prevention and management services into primary care settings. We obtained positive and promising results using this intervention. Trial registration: ClinicalTrials.gov, no.: NCT01319656.

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A proactive approach to migraine in primary care: a pragmatic randomized controlled trial.

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A proactive approach to migraine in primary care: a pragmatic randomized controlled trial.

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