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Study protocol of the ESUB-MG cluster randomized trial: a pragmatic trial assessing the implementation of urine drug screening in general practice for buprenorphine maintained patients

机译:ESUB-MG集群随机试验的研究方案:一项务实的试验,评估丁丙诺啡维持患者在一般实践中对尿液药物筛查的实施情况

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Background In addiction care, urine drug screening tests are recommended to assess psychoactive substances use. While intrinsic diagnostic value of these tests is demonstrated, the consequences of carrying out these tests on opiate maintenance treatment (OMT) have not been established. The main objective will be to assess the impact of on-site urine drug screening tests (OS-UDS) in general practice compared to routine medical care on OMT retention at 6 months in opioid-dependent patients initiating buprenorphine. Methods/Design The ESUB-MG study uses a pragmatic, cluster randomized controlled trial design. General Practitioners (GPs) regularly managing patients treated with buprenorphine and consenting for participating will be invited to participate. GPs will be randomly assigned to one of two groups for 6 to 24?months: (a) control group (usual care: standard medical strategy for assessing drug use); (b) interventional group (including 1/ a training session on practice and interpretation of OS-UDS; 2/ the supply of OS-UDS at GPs’ medical offices; 3/ performing an OS-UDS before the first prescription of buprénorphine). GPs will have to include 1 to 10 patients aged 18?years-old or more, consulting for starting treatment by buprenorphine, not opposed to participate. The primary outcome will be OMT retention at 6?months. Discussion This randomized interventional trial should bring sufficient level of evidence to assess effectiveness of performing OS-UDS in general practice for patients treated by buprenorphine. Training GPs to drug tests and supplying them in their office should lead to an improvement of opioid-addicted patients’ care through helping decision. Trials registration NCT02345655 (first registration May 14, 2014)
机译:背景技术在成瘾护理中,建议使用尿液药物筛查测试来评估精神活性物质的使用。尽管证明了这些测试的内在诊断价值,但尚未确定对鸦片维持治疗(OMT)进行这些测试的后果。主要目标是评估与常规医疗相比,现场尿液药物筛查测试(OS-UDS)与开始丁丙诺啡的阿片类药物依赖患者在6个月时OMT保留的影响。方法/设计ESUB-MG研究使用了一种实用的,整群随机对照的试验设计。定期管理接受丁丙诺啡治疗并同意参加的患者的全科医生将被邀请参加。全科医生将随机分配给两组之一,为期6到24个月:(a)对照组(常规护理:评估药物使用情况的标准医疗策略); (b)介入小组(包括1 /关于OS-UDS的实践和解释的培训课程; 2 //在全科医生的医疗办公室提供OS-UDS; 3 /在首次服用丁丙诺啡处方之前进行OS-UDS)。全科医生必须包括1至10名18岁或以上的患者,并咨询丁丙诺啡开始治疗,而不是反对参加。主要结果是OMT保留6个月。讨论该随机干预试验应提供足够水平的证据,以评估丁丙诺啡治疗的患者在一般实践中进行OS-UDS的有效性。对全科医生进行药物测试培训并将其提供给他们的办公室,应通过帮助决策来改善阿片类药物成瘾患者的护理。试用注册NCT02345655(首次注册,2014年5月14日)

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