Effects of VHA opioid policy on prescribing and patient-centered outcomes

 描述(由申请人提供)： 背景：慢性疼痛是一个重要的公共卫生问题，也是最常见和最致残的慢性病之一。经过20年的持续处方增加，阿片类止痛药是治疗慢性疼痛最常用的处方药物；然而，阿片类药物长期有效的证据不足。现在，新出现的与阿片类药物相关的危害的公共卫生流行病--特别是滥用和过量--引发了阿片类药物态度和政策的新时代，在这个时代，阿片类药物处方趋势正在积极扭转。退伍军人健康管理局(VHA)在疼痛管理方面一直处于全国领先地位--在促进提高对疼痛的认识的早期倡议中，在努力扩大获得疼痛治疗的分级护理模式的努力中，以及在应对新出现的与阿片类药物相关的严重伤害流行方面。VHA最近的阿片类药物政策包括对长期阿片类药物治疗和全系统阿片类药物安全目标的强制性书面知情同意，以增加阿片类药物风险管理工具的使用，减少高风险处方(例如，大剂量阿片类药物治疗)。由于这些VHA任务是在对阿片类药物的态度发生显著变化的更大背景下执行的，而且它们是以有效减少阿片类药物处方的先前政策为蓝本的，预计它们将大幅降低阿片类药物处方的比率和强度 在VHA。如果成功，VHA倡议将减少潜在的危险和阿片类药物的过度处方，并改善患有慢性疼痛的退伍军人的疼痛和生活质量(QOL)结果。目的：主要目的是了解接受阿片类药物治疗慢性疼痛的退伍军人中以患者为中心的阿片类药物处方变化的结果。该项目将调查接受长期阿片类药物治疗的VA初级保健患者的全国代表性样本，以收集患者报告的纵向疼痛结果数据。具体目的是在接受长期阿片类药物治疗的患者中检查1)阿片类药物日剂量变化与患者报告的疼痛和生活质量结果变化之间的关系；以及2)患者、提供者和设施因素与患者报告的疼痛和健康相关生活质量变化的关系，主要是通过它们对阿片类药物日剂量和非药物止痛疗法的使用的影响。方法：来自VHA数据集的现有数据将用于识别VA患者长期服用阿片类药物(定义为连续6个月)治疗慢性疼痛。从这一人群中，将使用多阶段随机抽样策略确定接受长期阿片类药物治疗的13675名VA初级保健患者的全国代表性样本。纳入样本的患者将被邀请参加纵向调查 在三个时间点(基线、12个月和24个月)调查并完成简短问卷。按照既定的最大限度地回复邮寄调查的方法，将在每个数据收集时间点通过邮件多次联系符合条件的患者，并提供最终的 无回应者的电话跟进。调查问卷将评估疼痛相关功能和健康相关生活质量作为主要结果，并将评估疼痛特征、患者对治疗的感知以及患者与提供者关系的各个方面作为协变量。VHA管理数据将用于评估患者使用非药物止痛疗法以及患者、提供者和设施协变量。预期的患者报告的调查数据将与行政数据合并，以进行分析，以解决具体目标。

 DESCRIPTION (provided by applicant): Background: Chronic pain is an important public health problem and among the most prevalent and disabling of chronic diseases. After two decades of sustained prescribing increases, opioid analgesics are the most commonly prescribed medications for chronic pain; however, evidence for long-term opioid effectiveness is insufficient. Now, an emerging public health epidemic of opioid-related harms-especially abuse and overdose-has triggered a new era in opioid attitudes and policies, in which opioid prescribing trends are being actively reversed. The Veterans Health Administration (VHA) has been a national leader in pain management-in early initiatives to promote greater awareness of pain, in efforts to expand access to a stepped care model of pain treatment, and in responses to the emerging epidemic of serious opioid-related harms. Recent VHA opioid policies include mandatory written informed consent for long-term opioid therapy and system-wide opioid safety goals to increase use of opioid risk management tools and decrease high-risk prescribing (e.g., high-dose opioid therapy). Because these VHA mandates are being implemented in a larger context of markedly changed attitudes towards opioids and because they are modeled on prior policies that have effectively reduced opioid prescribing, they are anticipated to substantially reduce rates and intensity of opioid prescribing in VHA. If successful, VHA initiatives will reduce potentially hazardous and excessive prescribing of opioids and improve pain and quality of life (QOL) outcomes among Veterans with chronic pain. Objectives: The main objective is to understand patient-centered outcomes of opioid prescribing changes among Veterans treated with opioids for chronic pain. The project will survey a nationally-representative sample of VA primary care patients receiving long-term opioid therapy to collect longitudinal patient-reported pain outcomes data. Specific aims are to examine, among patients receiving long-term opioid therapy, 1) the relationship between changes in opioid daily dose and changes in patient-reported pain and QOL outcomes; and 2) associations of patient, provider, and facility factors with changes in patient-reported pain and health- related QOL, primarily through their influence on opioid daily dose and use of non-pharmacological pain therapies. Methods: Existing data from VHA datasets will be used to identify VA patients prescribed long-term opioids (defined as = 6 consecutive months) for chronic pain. From this population, a nationally representative sample of 13,675 VA primary care patients receiving long-term opioid therapy will be identified using a multi-stage random sampling strategy. Patients included in the sample will be invited to participate in a longitudinal survey and complete brief questionnaires at three time points (baseline, 12 months, and 24 months). Following established methods for maximizing response to mailed surveys, eligible patients will be contacted multiple times by mail for each data collection time point, with a final telephone follow-up for non-responders. Questionnaires will assess pain-related function and health-related QOL as the primary outcomes and will assess pain characteristics, patient perception of treatment, and aspects of the patient-provider relationship as covariates. VHA administrative data will be used to assess patient use of non-pharmacological pain therapies and patient, provider, and facility covariates. Prospective patient-reported survey data will be merged with administrative data for analyses to address the specific aims.