The Headache Management Trial: A Randomized Study of Coordinated Care

Authors

  • David B. Matchar MD,

    1. From the Center for Clinical Health Policy Research, Duke University Medical Center, Durham, NC (D.B. Matchar, L. Harpole, G.P. Samsa, A. Jurgelski); Durham Veterans Administration Medical Center, Durham, NC (D.B. Matchar); Department of Medicine, Duke University Medical Center, Durham, NC (D.B. Matchar, L. Harpole, S. Kori); Department of Biostatistics and Bioinformatics, Duke University Medical Center Durham, NC (G.P. Samsa); Albert Einstein College of Medicine, Departments of Neurology, Epidemiology and Population Health, Bronx, NY (R.B. Lipton); Thomas Jefferson University Headache Center, Department of Neurology (S.D. Silberstein, W. Young); Kaiser Permanente San Diego, Neurology Research Department, San Diego, USA (A. Blumenfeld).
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  • Linda Harpole MD, MPH,

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    • Drs. Harpole and Kori are now with GlaxoSmithKline, Research Triangle Park, NC.

  • Gregory P. Samsa PhD,

    1. From the Center for Clinical Health Policy Research, Duke University Medical Center, Durham, NC (D.B. Matchar, L. Harpole, G.P. Samsa, A. Jurgelski); Durham Veterans Administration Medical Center, Durham, NC (D.B. Matchar); Department of Medicine, Duke University Medical Center, Durham, NC (D.B. Matchar, L. Harpole, S. Kori); Department of Biostatistics and Bioinformatics, Duke University Medical Center Durham, NC (G.P. Samsa); Albert Einstein College of Medicine, Departments of Neurology, Epidemiology and Population Health, Bronx, NY (R.B. Lipton); Thomas Jefferson University Headache Center, Department of Neurology (S.D. Silberstein, W. Young); Kaiser Permanente San Diego, Neurology Research Department, San Diego, USA (A. Blumenfeld).
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  • Annette Jurgelski MAT,

    1. From the Center for Clinical Health Policy Research, Duke University Medical Center, Durham, NC (D.B. Matchar, L. Harpole, G.P. Samsa, A. Jurgelski); Durham Veterans Administration Medical Center, Durham, NC (D.B. Matchar); Department of Medicine, Duke University Medical Center, Durham, NC (D.B. Matchar, L. Harpole, S. Kori); Department of Biostatistics and Bioinformatics, Duke University Medical Center Durham, NC (G.P. Samsa); Albert Einstein College of Medicine, Departments of Neurology, Epidemiology and Population Health, Bronx, NY (R.B. Lipton); Thomas Jefferson University Headache Center, Department of Neurology (S.D. Silberstein, W. Young); Kaiser Permanente San Diego, Neurology Research Department, San Diego, USA (A. Blumenfeld).
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  • Richard B. Lipton MD,

    1. From the Center for Clinical Health Policy Research, Duke University Medical Center, Durham, NC (D.B. Matchar, L. Harpole, G.P. Samsa, A. Jurgelski); Durham Veterans Administration Medical Center, Durham, NC (D.B. Matchar); Department of Medicine, Duke University Medical Center, Durham, NC (D.B. Matchar, L. Harpole, S. Kori); Department of Biostatistics and Bioinformatics, Duke University Medical Center Durham, NC (G.P. Samsa); Albert Einstein College of Medicine, Departments of Neurology, Epidemiology and Population Health, Bronx, NY (R.B. Lipton); Thomas Jefferson University Headache Center, Department of Neurology (S.D. Silberstein, W. Young); Kaiser Permanente San Diego, Neurology Research Department, San Diego, USA (A. Blumenfeld).
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  • Stephen D. Silberstein MD,

    1. From the Center for Clinical Health Policy Research, Duke University Medical Center, Durham, NC (D.B. Matchar, L. Harpole, G.P. Samsa, A. Jurgelski); Durham Veterans Administration Medical Center, Durham, NC (D.B. Matchar); Department of Medicine, Duke University Medical Center, Durham, NC (D.B. Matchar, L. Harpole, S. Kori); Department of Biostatistics and Bioinformatics, Duke University Medical Center Durham, NC (G.P. Samsa); Albert Einstein College of Medicine, Departments of Neurology, Epidemiology and Population Health, Bronx, NY (R.B. Lipton); Thomas Jefferson University Headache Center, Department of Neurology (S.D. Silberstein, W. Young); Kaiser Permanente San Diego, Neurology Research Department, San Diego, USA (A. Blumenfeld).
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  • William Young MD,

    1. From the Center for Clinical Health Policy Research, Duke University Medical Center, Durham, NC (D.B. Matchar, L. Harpole, G.P. Samsa, A. Jurgelski); Durham Veterans Administration Medical Center, Durham, NC (D.B. Matchar); Department of Medicine, Duke University Medical Center, Durham, NC (D.B. Matchar, L. Harpole, S. Kori); Department of Biostatistics and Bioinformatics, Duke University Medical Center Durham, NC (G.P. Samsa); Albert Einstein College of Medicine, Departments of Neurology, Epidemiology and Population Health, Bronx, NY (R.B. Lipton); Thomas Jefferson University Headache Center, Department of Neurology (S.D. Silberstein, W. Young); Kaiser Permanente San Diego, Neurology Research Department, San Diego, USA (A. Blumenfeld).
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  • Shashidhar Kori MD,

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  • Andrew Blumenfeld MD

    1. From the Center for Clinical Health Policy Research, Duke University Medical Center, Durham, NC (D.B. Matchar, L. Harpole, G.P. Samsa, A. Jurgelski); Durham Veterans Administration Medical Center, Durham, NC (D.B. Matchar); Department of Medicine, Duke University Medical Center, Durham, NC (D.B. Matchar, L. Harpole, S. Kori); Department of Biostatistics and Bioinformatics, Duke University Medical Center Durham, NC (G.P. Samsa); Albert Einstein College of Medicine, Departments of Neurology, Epidemiology and Population Health, Bronx, NY (R.B. Lipton); Thomas Jefferson University Headache Center, Department of Neurology (S.D. Silberstein, W. Young); Kaiser Permanente San Diego, Neurology Research Department, San Diego, USA (A. Blumenfeld).
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  • Conflict of Interest: Richard B. Lipton, MD, has consulted for, conducted studies funded by, and/or received lecture honoraria from Advanced Bionics, Allergan, AstraZeneca, Boehringer-Ingelheim, Bristol-Myers Squibb, Cierra, Endo, GlaxoSmithKline, Merck, Neuralieve, Ortho-McNeill, Pfizer, Pozen, ProEthics and St. Judes. The following authors have indicated no conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript: David B. Matchar, MD, Gregory P. Samsa, PhD, Annette Jurgelski, MAT. Drs. Harpole and Kori are presently employees of GlaxoSmithKline.

D.B. Matchar, Center for Clinical Health Policy Research, Duke University Medical Center, Wachovia Tower, Suite 220, 2200 W. Main Street, Durham, NC 27705, USA.

Abstract

Context.— Headache is a common, disabling disorder that is frequently not well managed in general clinical practice.

Objective.— To determine if patients cared for in a coordinated headache management program would achieve reduced headache disability compared with patients in usual care.

Design.— A randomized controlled trial of headache management vs usual care.

Setting.— Three distinctly different practice sites: an academic internal medicine practice located in a major east coast city, a staff-model managed care organization located in a major west coast city, and a community practice in a medium-sized city in the southeast.

Patients.— Individuals 21 years of age or older with chronic tension-type, migraine, or mixed etiology headache and a Migraine Disability Assessment (MIDAS) score greater than 5, not receiving treatment from a neurologist or headache clinic currently or within the previous 6 months and with an intention to continue general medical care at their current location and to continue their present health insurance coverage for the next 12 months.

Interventions.— Active intervention is a headache management program consisting of: (1) a class specifically designed to inform patients about headache types, triggers, and treatment options; (2) diagnosis and treatment by a professional especially trained in headache care (based on US Headache Consortium guidelines); and (3) proactive follow-up by a case manager. Participation lasted 6 months. Control patients received usual care from their primary care providers.

Main Outcome Measures.— The primary efficacy measure reported in this article is a comparison of MIDAS scores of headache disability between the intervention group and the control group at 6 months. Secondary measures were response at 12 months, general health and quality of life, and satisfaction with headache care.

Results.— The intervention improved (ie, decreased) MIDAS scores by 7.0 points (95% confidence interval 2.9 to 11.1) more than the control (P = .008) at 6 months. The difference was not affected by site (P = .59 for clinic by intervention interaction), and a trend toward persistent benefit at 12 months (mean difference in improvement 6.8 points, 95% confidence interval −.3 to 13.9, P = .06) was observed. Quality of life and satisfaction with headache treatment were similarly improved.

Conclusions.— Coordinated headache management significantly improved outcomes for patients who, despite contact with the healthcare system for headache, had substantial unmet needs. The intervention in this trial can be implemented practically in a wide range of settings with the expectation that meaningful improvements will accrue.

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