The objective of the proposed study is to determine whether headache management programs should be promoted as an effective and cost- effective strategy for managing patients with chronic disabling headache. The project seeks to translate the current evidence on headache management into clinical practice. Its foundations are the Agency for Healthcare Research and Quality technical reviews on the state-of-the-science in headache management and the practice guidelines based thereon developed by the Headache Guideline Consortium. The functional specifications for the headache management program were developed by an expert advisory panel on headache care, and pilottested in a demonstration project. The demonstration project achieved a reduction in headache-related disability and an improvement in quality of life and patient satisfaction for patients with chronic headache. The purpose of the headache management program is to assure appropriate headache diagnosis, patient education and activation, clinical treatment and management based upon the evidence-based guidelines, and regular patient monitoring and follow-up. In the proposed study, patients in three geographically and clinically diverse clinical settings, (a managed care organization in Southern California, an academic general internal medicine practice in Pennsylvania and a community-based practice in North Carolina) who are identified by their primary care physicians as having chronic disabling headache, will be randomized to usual care or to the headache management program. In total, 828 patients will be enrolled in the study, 414 in the control and 414 in the intervention group. Patients in the intervention arm will be enrolled in the headache management program for 6 months. Data collection will be by telephone and mail at baseline and by mail at 3, 6, 9, and 12 months. Outcomes will include headache-related disability, functional health status, patient satisfaction, appropriateness of care, and resource utilization. Data analysis will evaluate study group (intervention/control) as the primary predictor variable, and will incorporate hierarchical linear modeling techniques, given the nested nature of the data. Control variables (covariates) include site, physician, patient demographics, and clinical characteristics. Various outcome and process measures will be used as the dependent variable(s) in specific modeling exercises.
| Matchar, David B; Harpole, Linda; Samsa, Gregory P et al. (2008) The headache management trial: a randomized study of coordinated care. Headache 48:1294-310 |
