Re-engineering Methadone Treatment: A Randomized Clinical Trial

重新设计美沙酮治疗：随机临床试验

• 批准号: 8432868
• 负责人: ROBERT P SCHWARTZ
• 金额: $ 57.67万
• 依托单位: FRIENDS RESEARCH INSTITUTE, INC.
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-03-01 至 2015-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8432868
• 关键词: Abstinence; Accreditation; Admission activity; Agonist; Body Weight decreased; Caring; Categories; Chronic; Chronic Disease; Client satisfaction; Clinic; Cocaine Dependence; Conflict (Psychology); Costs and Benefits; Counseling; Crime; DSM-IV; Dependence; Diet; Drops; Drug Addiction; Drug abuse; Drug usage; Economics; Engineering; Enrollment; Environment; Fees; Goals; Gold; HIV Infections; HIV risk; Heroin; Heroin Dependence; Illicit Drugs; Imprisonment; Indium; Insulin; Interview; Lead; Measures; Medical; Medicine; Methadone; Modality; Modeling; Opiate Addiction; Opioid; Outcome; Outcome Measure; Overdose; Parents; Participant; Patient Discharge; Patient-Centered Care; Patients; Pharmaceutical Preparations; Policy Maker; Primary Health Care; Procedures; Professional counselor; Public Health; Quality of life; Randomized Clinical Trials; Recommendation; Regulation; Relative (related person); Research; Risk Behaviors; Role; Safety; Sampling; Services; Site; Structure; Testing; Therapeutic; Thinking; Time; Treatment outcome; Urine; active method; base; clinical practice; cocaine use; comparative; cost; cost effectiveness; criminal behavior; drug quality; effective therapy; flexibility; follow-up; improved; innovation; meetings; non-compliance; novel; novel strategies; outcome forecast; outreach; overdose death; parent grant; patient oriented; premature; prevent; programs; public health relevance; response; treatment as usual; treatment program

DESCRIPTION (provided by applicant): Premature discontinuation from methadone treatment programs (MTP) is a frequent occurrence and is associated with continued illicit drug use, HIV infection, overdose death, and crime. This resubmission of our competing renewal application builds on the findings of our parent grant (5R01DA 015842) in which nearly half of over 350 newly admitted MTP were no longer in treatment at 12-month follow-up, in large part because of the powerful influence of program rules and the role of the counselor as enforcer of the rules. Our goal is to test the impact of a fundamental re-engineering of MTPs, based on the conceptual model of patient-centered care (IOM, 2006),1 in order to avoid premature drop-out and to improve patient outcomes. Nearly all premature discharges in our parent R01 were due to: (1) "administrative" discharge, typically involuntary; (2) patient drop-out; or, (3) not being re-admitted after brief incarcerations. To reduce "administrative" discharge, PC-MTP will reorganize the staff roles and MTP rules. Counselors will not be responsible for enforcing the clinics' rules for their patients, patients will be encouraged but not required to participate in counseling, and most clinic rule infractions will result in consequences short of "administrative" discharge. Administrative discharge, found nowhere else in medicine although common among MTPs, is incongruent with the conceptualization of opioid addiction as a chronic disease. Relieving the counselor of the role of enforcer and making counseling voluntary should alleviate the inherent conflict and power imbalance thereby increasing the therapeutic alliance and patient satisfaction and hence treatment retention. Finally, patients will be actively welcomed by the MTP to return to treatment upon release without arbitrary deadlines to return and their counselors will conduct active outreach for participants not returning on their own. This two-site randomized clinical trial with 300 participants will compare, on an intent-to-treat basis, the relative efficacy of PC-MTP to treatment-as-usual MTP (TAU). Participants will be assessed at baseline and at 3, 6 and 12 months post-baseline. The study's aims are: (1) to compare the impact of PC-MTP to TAU on: a) days in treatment; b) heroin and cocaine use; c) HIV risk behavior; d) criminal behavior and arrest; e) quality of life; and f) likelihood of meeting DSM-IV criteria for heroin and cocaine dependence at 12 month follow-up; (2) on therapeutic alliance and patient satisfaction; and (3) cost, cost-effectiveness, and cost-benefit. This study promises to examine the re-engineering of an MTP structure that has largely remained unchanged for the past 40 years. Further, since some drug use is not tantamount to dependence, we are including measures of quality of life and DSM-IV drug dependence and hence, our findings may challenge the long held gold standard that considers complete abstinence as the most important measure of patient progress. Because of the poor prognosis of premature discharge in MTPs, increasing retention in treatment can have a powerful effect on overall patient outcome, public health and on cost-benefit of treatment.

描述（由申请人提供）：过早停止美沙酮治疗计划（MTP）是经常发生的，并且与持续的非法药物使用，艾滋病毒感染，过量死亡和犯罪有关。重新提交我们的竞争更新申请是基于我们的父母补助金（5R01DA 015842）的发现，在12个月的随访中，350多名新录取的MTP中有近一半不再接受治疗，这在很大程度上是因为项目规则的强大影响以及辅导员作为规则执行者的角色。我们的目标是测试基于以患者为中心的护理概念模型（IOM, 2006） 1的MTPs基本重新设计的影响，以避免过早退出并改善患者的预后。在我们的父母R01中，几乎所有的过早出院都是由于：(1)“行政”出院，通常是非自愿的；(2)患者退出；或者，(3)在短暂监禁后不再被重新接纳。为了减少“行政”排放，PC-MTP将重组员工角色和MTP规则。咨询师将不负责为患者执行诊所的规则，患者将被鼓励但不被要求参与咨询，大多数违反诊所规则的行为将导致“行政”出院的后果。行政释放，在医学上找不到其他地方，虽然在MTPs中很常见，与阿片类药物成瘾作为一种慢性疾病的概念不一致。解除咨询师的执行者角色，使咨询成为自愿性的，可以缓解内在的冲突和权力失衡，从而提高治疗联盟和患者满意度，从而提高治疗保留度。最后，MTP将积极欢迎患者在出院后重返治疗，而不会硬性规定返回的最后期限，他们的辅导员将对不自行返回的参与者进行积极的外展。这项有300名参与者的两点随机临床试验将比较PC-MTP与常规治疗MTP （TAU）的相对疗效。参与者将在基线和基线后3、6和12个月进行评估。该研究的目的是：(1)比较PC-MTP与TAU对以下方面的影响：a)治疗天数；B)海洛因和可卡因的使用；c) HIV风险行为；D)犯罪行为和逮捕；E)生活质量；f) 12个月随访时符合DSM-IV海洛因和可卡因依赖标准的可能性；(2)治疗联盟与患者满意度；(3)成本、成本效益和成本效益。本研究旨在研究在过去40年中基本保持不变的MTP结构的重新设计。此外，由于一些药物的使用并不等同于依赖，我们纳入了生活质量和DSM-IV药物依赖的测量，因此，我们的发现可能会挑战长期持有的黄金标准，即认为完全戒断是患者进展的最重要衡量标准。由于mtp患者过早出院的预后较差，增加治疗的保留时间可对患者的总体预后、公共卫生和治疗的成本效益产生强有力的影响。