Re-engineering Methadone Treatment: A Randomized Clinical Trial

重新设计美沙酮治疗：随机临床试验

基本信息

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
项目类别：
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

项目摘要

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）：提前终止美沙酮治疗计划 (MTP) 的情况经常发生，并且与持续使用非法药物、艾滋病毒感染、服药过量死亡和犯罪有关。我们重新提交的竞争续签申请是建立在我们的家长补助金 (5R01DA 015842) 的调查结果的基础上的，其中超过 350 名新入院的 MTP 中近一半在 12 个月的随访中不再接受治疗，这在很大程度上是因为强大的影响力项目规则以及辅导员作为规则执行者的作用。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 MTP 根本性重新设计的影响，以避免过早退出并改善患者治疗结果。我们的母体 R01 的几乎所有过早出院都是由于： (1) “行政”出院，通常是非自愿的； (2) 患者中途退出；或者，(3) 短暂监禁后未重新入院。为了减少“行政”解雇，PC-MTP 将重新组织人员角色和 MTP 规则。咨询师不会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都会导致除“行政”出院之外的后果。行政出院虽然在 MTP 中很常见，但在医学上其他地方都没有发现，这与阿片类药物成瘾作为一种慢性疾病的概念不一致。解除咨询师的强制执行者角色并使咨询成为自愿的可以缓解固有的冲突和权力失衡，从而增加治疗联盟和患者满意度，从而提高治疗保留率。最后，MTP 将积极欢迎患者在出院后返回接受治疗，而没有任意的返回期限，并且他们的顾问将为未自行返回的参与者进行积极的外展活动。这项有 300 名参与者参与的两地随机临床试验将在意向治疗的基础上比较 PC-MTP 与常规治疗 MTP (TAU) 的相对疗效。参与者将在基线以及基线后 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) 使用海洛因和可卡因； c) 艾滋病毒危险行为； d) 犯罪行为和逮捕； e) 生活质量； f) 在 12 个月的随访中满足 DSM-IV 海洛因和可卡因依赖标准的可能性； (2) 治疗联盟和患者满意度； (3)成本、成本效益和成本效益。这项研究有望对过去 40 年来基本保持不变的 MTP 结构进行重新设计。此外，由于某些药物的使用并不等于依赖，我们将生活质量和 DSM-IV 药物依赖的衡量标准纳入其中，因此，我们的研究结果可能会挑战长期持有的黄金标准，即认为完全戒断是衡量患者进展的最重要指标。由于 MTP 中过早出院的预后较差，因此增加治疗保留时间可能会对患者的总体结果、公众健康和治疗的成本效益产生重大影响。