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）：美沙酮治疗计划（MTP）的过早停药是经常发生的，并且与持续非法吸毒，HIV感染，过量死亡和犯罪有关。我们的竞争更新申请的这种重新提交是基于我们父母赠款（5R01DA 015842）的发现，其中，在350多个新接纳的MTP中，将近一半不再在12个月的随访中接受治疗，这在很大程度上是由于计划规则的强大影响力和辅导员作为规则执行的作用。我们的目标是根据以患者为中心的护理的概念模型（IOM，2006年）测试MTP的基本重新设计的影响，1为了避免过早辍学并改善患者的结果。我们父母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）患者辍学；或（3）短暂监禁后未重新加入。为了减少“行政”释放，PC-MTP将重组员工角色和MTP规则。辅导员将不负责为患者执行诊所的规则，将鼓励患者，但不需要参加咨询，大多数诊所规则违规会导致后果没有“行政”出院。尽管在MTP中常见，但在医学中没有其他地方的行政排放与阿片类药物成瘾为慢性疾病的概念化不一致。减轻辅导员的作用并自愿进行咨询，应减轻固有的冲突和权力失衡，从而增加治疗联盟和患者满意度，从而增加治疗。最后，MTP将积极欢迎患者在没有任意截止日期的情况下返回治疗后返回治疗，他们的辅导员将为不自行返回的参与者进行积极的宣传。这项具有300名参与者的两次随机临床试验将以意图对治疗为基础，将PC-MTP对治疗与普遍MTP（TAU）的相对疗效进行比较。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对TAU的影响：a）治疗日期； b）海洛因和可卡因使用； c）艾滋病毒风险行为； d）犯罪行为和逮捕； e）生活质量； f）在12个月的随访中符合海洛因和可卡因依赖的DSM-IV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。这项研究有望检查MTP结构的重新设计，该结构在过去40年中一直保持不变。此外，由于某些药物使用并不涉及依赖性，因此我们包括生活质量和DSM-IV药物依赖性的度量，因此我们的发现可能会挑战长期持有的黄金标准，这将完全禁止作为患者进步的最重要度量。由于MTP过早排放的预后不良，因此增加的治疗保留率会对患者的总体结果，公共卫生和治疗成本效益产生强大的影响。