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      The design of a randomized controlled trial to evaluate multi-dimensional effects of a section 1115 Medicaid demonstration waiver with community engagement requirements

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          Abstract

          Section 1115 demonstration waivers provide a mechanism for states to implement changes to their Medicaid programs. While such waivers are mandated to include evaluations of their impact, randomization – the gold standard for assessing causality – has not typically been a consideration. In a critical departure, the Commonwealth of Kentucky opted to pursue a two-arm randomized controlled trial (RCT) for their controversial 2018 Medicaid Demonstration waiver, which included work requirements as a condition for the subset of beneficiaries deemed able-bodied to maintain eligibility for benefits. Beneficiaries were randomized 9:1 to the new waiver program or a control group who would retain their current benefits as part of the existing Medicaid expansion program. To address potential bias from differential attrition from the Medicaid program that would accrue from solely analyzing administrative data, our team designed a rich, prospective, longitudinal survey to collect primary and secondary outcomes from six categories of interest to policymakers: insurance coverage, health care utilization and quality, health behaviors, socioeconomic measures, personal finances, and health outcomes. At baseline, a subset of survey participants was invited to participate in the collection of biometric samples via in-person follow-up visits, and a cross-section were also invited to participate in qualitative interviews. While the demonstration waiver was terminated before the program began, our study design illustrates that it is possible for other researchers and state agencies seeking to evaluate Medicaid demonstration waivers and other demonstration policies to work together to implement high quality randomized trials – even for controversial policies.

          Highlights

          • Randomized evaluations of Medicaid waivers are feasible to implement.

          • Kentucky's waiver program included a community engagement requirement.

          • We designed a randomized trial to evaluate Kentucky's waiver program.

          • The design included a prospective, longitudinal survey and qualitative interviews.

          • The waiver was not implemented but our work serves as a model for policymakers.

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          Author and article information

          Journal
          Contemp Clin Trials
          Contemp Clin Trials
          Contemporary Clinical Trials
          Published by Elsevier Inc.
          1551-7144
          1559-2030
          7 October 2020
          7 October 2020
          : 106173
          Affiliations
          [a ]Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA
          [b ]Center for Health Incentives and Behavioral Economics, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA
          [c ]Columbia Law School, New York, NY, USA
          [d ]Department of Population and Family Health, Mailman School of Public Heath, Columbia University, New York, NY, USA
          [e ]Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA
          [f ]Department of Medicine, Perelman School of Medicine, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA
          [g ]Center for Health Equity Research and Promotion, Cresencz VA Medical Center, Philadelphia, USA
          [h ]NORC at the University of Chicago, Bethesda MD and Chicago, IL, USA
          Author notes
          [* ]Corresponding author at: Center for Health Incentives and Behavioral Economics, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA.
          Article
          S1551-7144(20)30251-2 106173
          10.1016/j.cct.2020.106173
          7538873
          61f78229-c3f0-4d1a-951f-e4ac99602e47
          © 2020 Published by Elsevier Inc.

          Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.

          History
          : 12 June 2020
          : 13 September 2020
          : 17 September 2020
          Categories
          Article

          Medicine
          randomized controlled trial,medicaid demonstration waiver,policy evaluation,prospective survey

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