跳至主要内容
临床试验/NCT02378181
NCT02378181已完成不适用

Testing the Effectiveness of a Graphic Novel Health Education Curriculum for Patients With Addiction

Treatment Research Institute4 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2016年8月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
49
试验地点
4
主要终点
Shared Decision Making Conversations, as Measured by the Shared Decision Making Questionnaire (SDM-Q)

研究概览

简要总结

This study deploys a strategy to develop and evaluate a training-efficient, multimedia patient-centered Health Education Toolkit to promote shared decision making between counselors and patients. An existing evidence-based toolkit intervention will be adapted and redesigned by a patient and provider team into an engaging, narrative graphic novel curriculum useful in group and individual counseling. The proven behavioral interventions will be augmented with health education material focused on medication assisted treatment (MAT). We will assess feasibility and acceptability, and pilot test whether exposure to the Toolkit (TK) can shared decision making conversations, reduce substance use, and increase engagement with MAT.

详细描述

An existing evidence-based toolkit intervention will be adapted and redesigned by a patient and provider team into an engaging, narrative graphic novel curriculum useful in group and individual counseling. The proven behavioral interventions will be augmented with health education material focused on medication assisted treatment (MAT) and HIV risk reduction. Together, these materials will comprise the Health Education Toolkit. The Health Education Toolkit (TK) will employ a shared decision making model to encourage 1) increased recovery engagement by patients, and 2) patient engagement in deciding whether to initiate and adhere to MAT. We will conduct a randomized pilot trial of 50 patients with active alcohol substance use disorders (SUDs) enrolled in inpatient or outpatient treatment and will follow them over 3 months. We will test whether patients randomized to receive the TK curriculum will report increased shared decision making conversations, report greater satisfaction and acceptability of their treatment sessions, demonstrate larger reductions in substance use (drug and alcohol) and increases in abstinence, demonstrate improved alcohol severity scores, attend more attendance at specialty substance abuse intervention and treatment sessions, and demonstrate greater rates of initiating MAT for alcohol dependence over the 3-month follow-up period as compared to patients receiving treatment-as-usual (TAU).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years or older
  • Screening score of at least 16 on the AUDIT
  • Meets criteria for a DSM-V substance use disorder as assessed via the MINI Plus 5.
  • Reports at least two heavy drinking episodes in the previous 4 weeks

排除标准

  • Reports plans to leave the Philadelphia greater metropolitan area within the next 6 months
  • Does not speak English
  • Unable to provide valid informed consent

结局指标

主要结局

Shared Decision Making Conversations, as Measured by the Shared Decision Making Questionnaire (SDM-Q)

时间窗: 3 months

Shared decision making score, as measured by the Shared Decision Making Questionnaire (SDM-Q) which uses a 1-6 point scale with higher numbers indicating greater shared decision-making. Results are presented for one research site only because of counselor randomization issues at the second site (i.e., the randomization was extremely unbalanced with 7 TAU counselors and 1 TK counselor).

Treatment Satisfaction and Acceptability, as Measured by the Satisfaction Survey

时间窗: 3 months

Satisfaction and acceptability of treatment sessions measured on a 1-5 scale with higher scores indicating greater satisfaction. Results are presented for one research site only because of counselor randomization issues at the second site (i.e., the randomization was extremely unbalanced with 7 TAU counselors and 1 TK counselor).

次要结局

  • Substance Use, as Measured by the Timeline Followback and Confirmed by Urinalysis(3 months)
  • Medication Assisted Treatment (MAT) Initiation, as Measured by a Utilization Review(3 months)
  • Substance Abuse Treatment Session Attendance, as Measured by the Non-Study Medical and Other Services (NSMOS)(6 weeks, 3 months)

研究者

发起方
Treatment Research Institute
申办方类型
Other
责任方
Sponsor

研究点 (4)

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