Toward Safer Opioid Prescribing in HIV care (TOWER): a mixed-methods, cluster-randomized trial.
Toward Safer Opioid Prescribing in HIV care (TOWER): a mixed-methods, cluster-randomized trial.
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DOI：
10.1186/s13722-022-00311-8
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发表时间：
2022-05-16
影响因子：
3.7
通讯作者：
Robinson-Papp, Jessica
中科院分区：
文献类型：
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作者：
Cedillo, Gabriela;George, Mary Catherine;Deshpande, Richa;Benn, Emma K. T.;Navis, Allison;Nmashie, Alexandra;Siddiqui, Alina;Mueller, Bridget R.;Chikamoto, Yosuke;Weiss, Linda;Scherer, Maya;Kamler, Alexandra;Aberg, Judith A.;Vickrey, Barbara G.;Bryan, Angela;Horn, Brady;Starkweather, Angela;Fisher, Jeffrey;Robinson-Papp, Jessica
2016年美国疾病控制中心阿片类药物处方指南（CDC指南）目前正在修订，因为人们担心它可能对长期阿片类药物治疗（CP-LTOT）的慢性疼痛患者有害。然而，缺乏一种方法来忠实地执行CDC指南，衡量处方者的依从性，并系统地测试其对患者和公共卫生结果的影响。我们开发并测试了CDC指南实施策略（称为塔），重点是门诊艾滋病毒为重点的初级保健设置。TOWER是在信息、动机和行为技能（IMB）行为改变框架内，在一个企业参与的多步骤迭代过程中开发的。塔包括：1）面向患者的阿片类药物管理应用程序（OM-App）; 2）用于指导诊室访视的病程记录模板（OM-Note）;以及3）初级保健提供者（PCP）培训。TOWER在一项为期9个月的随机对照试验中进行了评估，试验对象为HIV-PCP（N = 11）及其HIV和CP-LTOT患者（N = 40）。主要结局是基于电子健康记录（EHR）文件的CDC指南依从性，并通过经验证的更安全阿片类药物处方评估工具（SOPET）进行测量。收集了定性数据，包括一对一的PCP访谈。我们还试行了患者报告的结局指标（PROM），反映了利益相关者认为重要的领域（疼痛强度和功能;情绪;物质使用;药物使用和依从性;与提供者的关系;耻辱和歧视）。随机分配至TOWER组的PCP对CDC指南的依从性提高了48%（p < 0.0001），在以下方面的使用有显著改善：非药物治疗、功能性治疗目标、阿片类药物协议、处方药监测计划（PDMP）、阿片类药物获益/危害评估和纳洛酮处方。定性数据表明，在干预提供者中进行这些护理过程的信心很高，OM-Note支持这些努力，而OM-App的经验好坏参半。没有干预相关的安全性问题（定义为任何PROM恶化）。CDC指南的依从性可以得到促进和衡量，并且与接受LTOT治疗CP的HIV感染者的结局恶化无关。未来的工作将需要记录这些结果的可扩展性，并确定CDC指南的遵守是否会对公共卫生产生积极影响。试用注册https://clinicaltrials.gov/ct2/show/NCT03669939。注册日期：2018年9月13日
The 2016 U.S. Centers for Disease Control Opioid Prescribing Guideline (CDC Guideline) is currently being revised amid concern that it may be harmful to people with chronic pain on long-term opioid therapy (CP-LTOT). However, a methodology to faithfully implement the CDC guideline, measure prescriber adherence, and systematically test its effect on patient and public health outcomes is lacking. We developed and tested a CDC Guideline implementation strategy (termed TOWER), focusing on an outpatient HIV-focused primary care setting. TOWER was developed in a stakeholder-engaged, multi-step iterative process within an Information, Motivation and Behavioral Skills (IMB) framework of behavior change. TOWER consists of: 1) a patient-facing opioid management app (OM-App); 2) a progress note template (OM-Note) to guide the office visit; and 3) a primary care provider (PCP) training. TOWER was evaluated in a 9-month, randomized-controlled trial of HIV-PCPs (N = 11) and their patients with HIV and CP-LTOT (N = 40). The primary outcome was CDC Guideline adherence based on electronic health record (EHR) documentation and measured by the validated Safer Opioid Prescribing Evaluation Tool (SOPET). Qualitative data including one-on-one PCP interviews were collected. We also piloted patient-reported outcome measures (PROMs) reflective of domains identified as important by stakeholders (pain intensity and function; mood; substance use; medication use and adherence; relationship with provider; stigma and discrimination). PCPs randomized to TOWER were 48% more CDC Guideline adherent (p < 0.0001) with significant improvements in use of: non-pharmacologic treatments, functional treatment goals, opioid agreements, prescription drug monitoring programs (PDMPs), opioid benefit/harm assessment, and naloxone prescribing. Qualitative data demonstrated high levels of confidence in conducting these care processes among intervention providers, and that OM-Note supported these efforts while experience with OM-App was mixed. There were no intervention-associated safety concerns (defined as worsening of any of the PROMs). CDC-guideline adherence can be promoted and measured, and is not associated with worsening of outcomes for people with HIV receiving LTOT for CP. Future work would be needed to document scalability of these results and to determine whether CDC-guideline adherence results in a positive effect on public health. Trial registration https://clinicaltrials.gov/ct2/show/NCT03669939. Registration date: 9/13/2018
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DOI：
10.1097/qai.0000000000001741
发表时间：
2018-09-01
期刊：
Journal of acquired immune deficiency syndromes (1999)
影响因子：
--
作者：
Merlin JS;Long D;Becker WC;Cachay ER;Christopoulos KA;Claborn K;Crane HM;Edelman EJ;Harding R;Kertesz SG;Liebschutz JM;Mathews WC;Mugavero MJ;Napravnik S;C OʼCleirigh C;Saag MS;Starrels JL;Gross R
通讯作者：
Gross R
影响因子：
39
作者：
Liebschutz JM;Xuan Z;Shanahan CW;LaRochelle M;Keosaian J;Beers D;Guara G;O'Connor K;Alford DP;Parker V;Weiss RD;Samet JH;Crosson J;Cushman PA;Lasser KE
通讯作者：
Lasser KE
影响因子：
6
作者：
Davis, Corey S.;Lieberman, Amy Judd
通讯作者：
Lieberman, Amy Judd
影响因子：
7.4
作者：
Butler, Stephen F.;Budman, Simon H.;Jamison, Robert N.
通讯作者：
Jamison, Robert N.
影响因子：
13.8
作者：
Fenton, Joshua J.;Agnoli, Alicia L.;Magnan, Elizabeth
通讯作者：
Magnan, Elizabeth