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

评估和验证一种新工具，用于评估患有或不患有阿片类药物使用障碍的孕妇的社会心理和药物史背景

• 批准号: 10054774
• 负责人: Heidi Preis
• 金额: $ 19.77万
• 依托单位: STATE UNIVERSITY NEW YORK STONY BROOK
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-30 至 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10054774
• 关键词: Abstinence; Affect; Alcohol or Other Drugs use; Ambulatory Care Facilities; Behavioral; Behavioral Mechanisms; Birth; Caring; Characteristics; Child; Clinical; Clinical Research; Cognitive; Collection; Communities; Computerized Medical Record; Data; Data Set; Detection; Device or Instrument Development; Diagnosis; Discipline of obstetrics; Drug abuse; Ensure; Evaluation; Feedback; Health; Health Personnel; Health Psychology; Health behavior; Infant; Interpersonal Violence; Intervention; Interview; Knowledge; Length; Long Island; Longitudinal Studies; Low Birth Weight Infant; Medicine; Mothers; Motivation; New York; Opioid; Outcome; Outpatients; Paper; Participant; Patient Self-Report; Patients; Personal Satisfaction; Pharmaceutical Preparations; Phase; Population; Population Heterogeneity; Pregnancy; Pregnant Women; Premature Birth; Prenatal care; Provider; Psychology; Psychometrics; Psychosocial Assessment and Care; Recommendation; Recording of previous events; Research; Research Methodology; Research Personnel; Risk; Risk Assessment; Risk Factors; Screening procedure; Self Efficacy; Sensitivity and Specificity; Severities; Social Work; Social support; Standardization; Stress; Substance abuse problem; Tablets; Toxicology; Treatment Effectiveness; United States National Institutes of Health; Universities; University Hospitals; Validation; Woman; addiction; adverse birth outcomes; base; biobehavior; brief screening; care providers; clinical efficacy; clinical practice; compare effectiveness; computerized; craving; design; digital; evidence base; improved; individualized medicine; instrument; maternal stress; medication-assisted treatment; member; multidisciplinary; non-opioid analgesic; novel; offspring; opioid epidemic; opioid use disorder; opioid use in pregnancy; patient response; perinatal health; perinatal outcomes; physical conditioning; prenatal; prenatal health; profiles in patients; programs; prospective; psychosocial; screening; screening, brief intervention, referral, and treatment; social; sociodemographic variables; tool; treatment adherence

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.

项目摘要/摘要 在美国，怀孕期间阿片类药物使用障碍(OUD)正在以惊人的速度增加。有效 心理社会和物质使用筛查对于促进对患有或 由于心理社会特征被认为有助于产前健康行为，因此 药物辅助治疗的依从性，并因此与分娩结局有关。然而，尽管 关于全面普遍的心理社会和物质使用筛查的建议，有 阻碍这些系统应用的专业、社会和技术障碍 建议。目前的项目将评估、修改和数字化一个新颖的、多用途的、简短的、自我的 报告筛选工具：母亲阿片类药物治疗有效性简介(PROCESS)。这个 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 变量、压力、人际暴力、社会支持、药物滥用严重程度和渴求，以及 治疗动机)，这可能会影响患有或不患有脐带血的孕妇。系统评估 这些漏洞便于健康人员进行筛查、简短干预和转诊治疗(SBIRT 照顾者。这项推广活动最近在石溪大学产前门诊患者中实施 诊所包括一项针对患有先天性巨结肠症的妇女的专门计划。该项目的目标是确认和 提高促进筛查工具的科学效度和临床疗效。在阶段1中，评估 促进的效度，我们将：1)前瞻性评估结构和标准的效度 推广与由90名妇女完成的既定全长乐器相比，没有OUD和 90名患有OUD的妇女；1b)评估促进会的预测效度(OUD检测的准确性) 在1,000名患者中；1c)定性评估Promote的可接受性和内容有效性(in 英文或西班牙文)。在第二阶段，我们将根据患者的反应来细化推广。在第三阶段， 我们将试行数字版的推广。在此阶段，使用基于社区的参与式 通过这种方法，我们将让受影响的利益攸关方参与进来，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。调查结果将 使推广和使用得到改进，以便在本项目之后可以传播到 产前、成瘾和综合护理环境，以促进收集重要的临床和研究数据 以支持SBIRT。此外，我们将提出一个大规模的多中心项目，利用精炼的， 数字化促进研究有助于身体健康的生物行为和心理社会机制 所有患有或不患有胎儿窘迫综合征的孕妇及其子女的健康和福祉。