Health and economic outcomes of treatment with extended-release naltrexone among pre-release prisoners with opioid use disorder (HOPPER): protocol for an evaluation of two randomized effectiveness trials
Health and economic outcomes of treatment with extended-release naltrexone among pre-release prisoners with opioid use disorder (HOPPER): protocol for an evaluation of two randomized effectiveness trials
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DOI：
10.1186/s13722-020-00188-5
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发表时间：
2020-04-22
影响因子：
3.7
通讯作者：
Polsky, Daniel
中科院分区：
文献类型：
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作者：
Murphy, Sean M.;Jeng, Philip J.;Polsky, Daniel
背景：被监禁的阿片类药物使用障碍（OUD）患者在保持戒断方面面临许多挑战；与此同时，阿片类药物过量是这一人群死亡的主要原因，在释放后的最初几周尤其致命。缓释纳曲酮（XR-NTX）是刑事司法环境中最广泛接受的循证OUD药物治疗，可确保约30天的阿片类药物过量保护。XR-NTX的高成本阻碍了许多监狱系统的使用；然而，不应孤立地看待药物的成本。监狱/监狱医疗保健预算最终由决策者决定，与有效的OUD治疗相关的效益/成本抵消将直接和间接影响到他们的总体预算和整个社会。方法：本方案描述了一项由国家药物滥用研究所（NIDA）资助的研究，旨在评估与释放OUD患者不同XR-NTX递送策略相关的医疗保健利用、健康相关生活质量和其他资源的变化；并估计每种策略的相对“价值”。来自两项正在进行的、公共资助的随机对照试验的数据将用于评估这些问题。在研究A中，（XR-NTX再入前与再入后），参与者被随机分配在释放前或释放后接受第一次XR-NTX剂量。在研究B中（增强XR-NTX vs. XR-NTX），两组患者在释放前均接受XR-NTX；增强臂在释放后接受移动医疗（居住地）XR-NTX治疗，XR-NTX臂在释放后接受转介到社区治疗方案。从基线开始，两项研究都纳入了评估相关结果所需的经济数据收集工具。此外，由于两项试验在可比较的人群中使用了相同的工具，我们不仅有机会评估每个试验中研究组之间结果的差异，而且还可以合并数据集并测试试验之间的差异。在释放前开始XR-NTX治疗OUD可能会改善患者的健康和福祉，同时也会产生下游成本抵消。本研究提供了独特的机会，根据不同的利益相关者的观点来评估多种战略的有效性和成本效益。
Background Persons with an opioid use disorder (OUD) who were incarcerated face many challenges to remaining abstinent; concomitantly, opioid-overdose is the leading cause of death among this population, with the initial weeks following release proving especially fatal. Extended-release naltrexone (XR-NTX) is the most widely-accepted, evidence-based OUD pharmacotherapy in criminal justice settings, and ensures approximately 30 days of protection from opioid overdose. The high cost of XR-NTX serves as a barrier to uptake by many prison/jail systems; however, the cost of the medication should not be viewed in isolation. Prison/jail healthcare budgets are ultimately determined by policymakers, and the benefits/cost-offsets associated with effective OUD treatment will directly and indirectly affect their overall budgets, and society as a whole. Methods This protocol describes a study funded by the National Institute of Drug Abuse (NIDA) to: evaluate changes in healthcare utilization, health-related quality-of-life, and other resources associated with different strategies of XR-NTX delivery to persons with OUD being released from incarceration; and estimate the relative "value" of each strategy. Data from two ongoing, publicly-funded, randomized-controlled trials will be used to evaluate these questions. In Study A, (XR-NTX Before vs. After Reentry), participants are randomized to receive their first XR-NTX dose before release, or at a nearby program post-release. In Study B, (enhanced XR-NTX vs. XR-NTX), both arms receive XR-NTX prior to release; the enhanced arm receives mobile medical (place of residence) XR-NTX treatment post-release, and the XR-NTX arm receives referral to a community treatment program post-release. The economic data collection instruments required to evaluate outcomes of interest were incorporated into both studies from baseline. Moreover, because the same instruments are being used in both trials on comparable populations, we have the opportunity to not only assess differences in outcomes between study arms within each trial, but also to merge the data sets and test for differences across trials. Discussion Initiating XR-NTX for OUD prior to release from incarceration may improve patient health and well-being, while also producing downstream cost-offsets. This study offers the unique opportunity to assess the effectiveness and cost-effectiveness of multiple strategies, according to different stakeholder perspectives.