Opioid Use Disorder Treatment Linkage at STD Clinics using Buprenorphine (OUTLAST-B)

在 STD 诊所使用丁丙诺啡治疗阿片类药物使用障碍治疗联动 (OUTLAST-B)

基本信息

批准号：
10348119
负责人：
Jan Gryczynski
金额：
$ 68.8万
依托单位：
FRIENDS RESEARCH INSTITUTE, INC.
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-04-15 至 2025-01-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10348119
关键词：
Accident and Emergency department Adherence Admission activity Antibiotics Appointment Authorization documentation Behavior Biological Markers Buprenorphine Caring Centers for Disease Control and Prevention (U.S.)Clinic Clinic Visits Communities Coupled Data Drug usage Epidemic Event Exposure to Fentanyl Funding HIV HIV Infections Health Health Services Heroin High Prevalence Hospitals Hotlines Individual Intake Interview Jail Lead Link Medical Methods Morbidity - disease rate Naloxone National Institute of Drug Abuse Nurse Practitioners Opiate Addiction Opioid Analgesics Outcome Outpatients Overdose Participant Patients Pharmaceutical Preparations Physician Assistants Physicians Population Primary Care Provider Public Health Recommendation Regimen Reporting Research Research Design Resources Risk Risk Behaviors Services Sexually Transmitted Diseases Statutes and Laws Structure Substance Use Disorder Testing Time United States Walking Writing arm authority buprenorphine treatment care seeking cost effective therapy effectiveness evaluation experience follow-up health record high risk high risk population illicit opioid innovation meetings mortality novel novel strategies opioid epidemic opioid use opioid use disorder overdose death overdose prevention patient navigation patient navigator patient population prescription opioid primary outcome public health emergency randomized, clinical trials treatment as usual treatment program trial comparing usual care arm waiver

项目摘要

Abstract Untreated opioid use disorder (OUD) is a continuing public health emergency in the United States. OUD is associated with significant morbidity and mortality, including overdose death. Buprenorphine is an effective treatment for OUD, but most individuals who need such treatment do not access it. Public STD clinics are high-volume, episodic care medical settings that serve a high-risk population, often on a walk-in basis. STD clinic patients have high prevalence of OUD and health-risking behaviors. This proposed study, entitled Opioid Use Disorder Treatment Linkage at STD Clinics using Buprenorphine (OUTLAST-B), will examine OUD treatment linkage strategies for opioid-dependent patients seeking services at public STD clinics. This three-arm, parallel randomized clinical trial (RCT) will compare Usual Care (UC), vs. referral via Patient Navigation (PN), vs. Patient Navigation with STD-clinic initiated buprenorphine (PN+BUP). The UC Arm will include standard services at the STD clinic. The PN Arm will include all UC Arm services, with the addition of a Patient Navigator who will assist the participant in selecting a community OUD treatment program, facilitate an intake appointment, help to resolve barriers and coordinate OUD treatment entry, and support early retention in OUD treatment. The PN+BUP Arm will include all PN Arm services, with the addition of meeting with the STD clinic’s buprenorphine-waivered provider (typically a nurse practitioner) to initiate buprenorphine treatment, as a bridge until successful transfer to OUD treatment in the community. Research assessments consisting of a structured interview battery and biomarkers for drug use and STDs will be conducted at baseline, 3-, and 6-month follow-up. Selected outcomes will be examined through 12-months via health record linkage methods. The study will examine participant outcomes in the domains of: (1) OUD treatment entry and retention, (2) Opioid use and related problems (including fatal and non-fatal overdose), and (3) HIV/STD-related outcomes. This innovative study could identify new approaches to engaging a high-risk patient population in OUD treatment. The study could have high impact because findings could be scaled to STD clinics throughout the nation, spurring novel integration across two traditionally separate service sectors of STD care and OUD treatment.

抽象的未经处理的阿片类药物使用障碍（OUD）是美国持续的公共卫生紧急情况。 Oud是与明显的发病率和死亡率有关，包括过量死亡。丁丙诺啡是有效的 OUD的治疗方法，但是大多数需要这种治疗的人都无法访问它。公共性病诊所是为高风险人口提供服务的大量，情节护理的医疗环境，通常在步入基础。性病诊所患者的OUD和健康风险行为患病率很高。这项拟议的研究，标题为“阿片类药物使用障碍治疗连接”在性病诊所使用丁丙诺啡（Outlast-B），将检查与阿片类药物依赖性患者寻求服务的OUD治疗连锁策略在公共性病诊所。这项三臂平行的随机临床试验（RCT）将比较常规护理（UC），VS。通过患者导航（PN）推荐，与患者导航，具有性病 - 临床引发的丁丙诺啡（PN+BUP）。 UC ARM将在STD诊所包括标准服务。 PN臂将包括所有UC ARM服务，随着添加患者导航员，他将协助参与选择社区Oud治疗计划，促进预约，帮助解决障碍和协调OUD治疗条目，以及支持在OUD治疗中的早期保留。 PN+BUP臂将包括所有PN ARM服务，并加上与STD诊所的丁丙诺啡招聘提供商（通常是护士从业者）会面以启动丁丙诺啡治疗是桥梁，直到成功地转移到社区中的Oud治疗为止。由结构化访谈电池和用于吸毒和性病的生物标志物组成的研究评估将在基线，3个月和6个月的随访中进行。选定的结果将通过12个月进行检查通过健康记录联系方法。该研究将检查以下领域的参与者结果：（1）OUD 治疗进入和保留，（2）阿片类药物使用以及相关问题（包括致命和非致命过量），（3）HIV/STD相关的结果。这项创新的研究可以确定与Oud参与高风险患者人群的新方法治疗。这项研究可能会产生很大的影响国家，刺激了两个传统上独立的STD护理和Oud服务领域的新颖融合治疗。