Evaluation and validation of a novel instrument to assess the psychosocial and drug history backgrounds of pregnant women with or without Opioid Use Disorder

项目总结/摘要 在美国，怀孕期间的阿片类药物使用障碍（OUD）正在以惊人的速度增加。有效 社会心理和药物使用筛查对于推进研究和护理患有或 没有OUD，因为已知心理社会特征有助于产前健康行为， 药物辅助治疗依从性，因此，出生结果。但尽管 建议全面普遍的心理社会和物质使用筛查，有 专业，社会和技术障碍，阻碍了这些系统的应用 建议.目前的项目将评估，修改，并重新设计一种新颖的，多用途的，简短的，自我- 报告筛选工具：母体阿片类药物治疗有效性概况（PROMOTE）。的 PROMOTE是由临床医生和研究人员组成的多学科团队开发的， 理论上和临床上相关的心理社会和物质使用风险因素（例如社会人口统计学 变量、压力、人际暴力、社会支持、药物滥用严重程度和渴望，以及 治疗动机），这可能会影响孕妇或没有OUD。系统地评估 这些脆弱性促进了健康筛查、短期干预和转诊治疗（SBIRT） 护理提供者。PROMOTE最近在斯托尼布鲁克大学产前门诊实施 诊所，包括一个专门的计划，为妇女与OUD。该项目的目的是确认和 提高PROMOTE筛查工具的科学有效性和临床疗效。在第一阶段，评估 PROMOTE的有效性，我们将：1a）前瞻性地评估结构和标准的有效性， PROMOTE与90名无OUD女性完成的已确定全长器械相比， 90名OUD女性; 1b）评估PROMOTE的预测有效性（OUD检测的准确性） 1c）定性评估PROMOTE的可接受性和内容效度（在 英文或西班牙文）。在第2阶段，我们将根据患者的反应完善PROMOTE。在第三阶段， 我们将试行数字版的宣传册。在这一阶段，使用基于社区的参与式 在这种方法中，我们将让受影响的利益相关者参与进来，包括患者、办公室工作人员和护理提供者。 改善孕妇的治疗和健康结果是国家的当务之急。发现将 完善PROMOTE及其使用，以便在该项目之后，可以将其传播到 产前、成瘾和综合护理环境，以促进重要临床和研究数据的收集， 支持SBIRT。此外，我们将提出一个大规模的，多中心的项目，利用完善， 数字化的PROMOTE，以调查生物行为和心理社会机制，有助于身体 所有患有或没有OUD的孕妇及其子女的健康和福祉。

Project Summary/Abstract Opioid Use Disorder (OUD) during pregnancy in the US is increasing at alarming rates. Effective psychosocial and substance use screening is vital to advance research and care for mothers with or without OUD since psychosocial characteristics are known to contribute to prenatal health behaviors, to medication-assisted treatment adherence, and consequently, to birth outcomes. Yet, despite recommendations for comprehensive universal psychosocial and substance use screening, there are professional, social, and technical barriers which hinder the systematic application of these recommendations. The current project will evaluate, modify, and digitize a novel, multipurpose, brief, self- report screening tool: the Profile for Maternal Opioid Treatment Effectiveness (PROMOTE). The PROMOTE was developed by a multidisciplinary team of clinicians and researchers and captures theoretically and clinically pertinent psychosocial and substance use risk factors (e.g. socio-demographic variables, stress, interpersonal violence, social support, substance abuse severity and craving, and treatment motivation) which can affect pregnant women with or without OUD. Systematically assessing these vulnerabilities facilitates Screening, Brief Intervention, and Referral to Treatment (SBIRT) by health care providers. The PROMOTE was recently implemented in Stony Brook University prenatal outpatient clinics including a specialized program for women with OUD. The aims of this project are to confirm and enhance the scientific validity and clinical efficacy of the PROMOTE screening tool. In Phase 1, to evaluate the validity of the PROMOTE, we will: 1a) prospectively evaluate construct and criterion validity of the PROMOTE compared with established full-length instruments completed by 90 women without OUD and 90 women with OUD; 1b) evaluate the predictive validity (accuracy of OUD detection) of the PROMOTE among 1,000 patients; 1c) qualitatively assess the acceptability and content validity of the PROMOTE (in English or in Spanish). In Phase 2, we will refine the PROMOTE based on patient response. In Phase 3, we will pilot a digital version of the PROMOTE. In this phase, using a community-based participatory approach, we will involve affected stakeholders, including patients, office staff, and care providers. Improving treatment and health outcomes of pregnant women is a national imperative. Findings will enable refinement of the PROMOTE and its use so that subsequent to this project it can be disseminated to prenatal, addiction, and integrated care settings to facilitate collection of vital clinical and research data and to support SBIRT. Additionally, we will propose a large scale, multicenter project utilizing the refined, digitized PROMOTE to investigate biobehavioral and psychosocial mechanisms that contribute to physical health and well-being among all pregnant women with or without OUD and their offspring.