Study protocol
A controlled trial of value-based insurance design – The MHealthy: Focus on Diabetes (FOD) trial
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* Corresponding author: Allison B Rosen abrosen@umich.edu
1 Department of Internal Medicine, University of Michigan School of Medicine, Ann Arbor, MI, USA
2 Division of Epidemiology and Community Health, University of Minnesota School of Public Health, Minneapolis, MN, USA
3 Department of Health Management and Policy, University of Michigan School of Public Health, Ann Arbor, MI, USA
4 Department of Epidemiology, University of Michigan School of Public Health, Ann Arbor, MI, USA
5 Department of Clinical, Social and Administrative Sciences, University of Michigan College of Pharmacy, Ann Arbor, MI, USA
6 Department of Health Care Policy, Harvard University School of Medicine, Boston, MA
7 University of Michigan Benefits Office, Ann Arbor, MI, USA
8 Ann Arbor VA HSR&D Center of Excellence, Ann Arbor Veterans Affairs Medical Center, Ann Arbor, MI, USA
Implementation Science 2009, 4:19 doi:10.1186/1748-5908-4-19
Published: 7 April 2009Abstract
Background
Diabetes affects over 20 million Americans, resulting in substantial morbidity, mortality, and costs. While medications are the cornerstone of secondary prevention, many evidence-based therapies are underutilized, and patients often cite out-of-pocket costs as the reason. Value-based insurance design (VBID) is a 'clinically sensitive' refinement to benefit design which links patient cost-sharing to therapy value; the more clinically beneficial (and valuable) a therapy is for a patient, the lower that patient's cost-sharing should be. We describe the design and implementation of MHealthy: Focus on Diabetes (FOD), a prospective, controlled trial of targeted co-payment reductions for high value, underutilized therapies for individuals with diabetes.
Methods
The FOD trial includes 2,507 employees and dependents with diabetes insured by one large employer. Approximately 81% are enrolled in a single independent-practice association model health maintenance organization. The control group includes 8,637 patients with diabetes covered by other employers and enrolled in the same managed care organization. Both groups received written materials about the importance of adherence to secondary prevention therapies, while only the intervention group received targeted co-payment reductions for glycemic agents, antihypertensives, lipid-lowering agents, antidepressants, and diabetic eye exams. Primary outcomes include medication uptake and adherence. Secondary outcomes include health care utilization and expenditures. An interrupted time series, control group design will allow rigorous assessment of the intervention's impact, while controlling for unrelated temporal trends. Individual patient-level baseline data are presented.
Discussion
To our knowledge, this is the first prospective controlled trial of co-payment reductions targeted to high-value services for high-risk patients. It will provide important information on feasibility of implementation and effectiveness of VBID in a real-world setting. This program has the potential for broad dissemination to other employers and insurers wishing to improve the value of their health care spending.