跳至主要内容
临床试验/NCT03669939
NCT03669939已完成不适用

Toward Safer Opioid Prescribing for Chronic Pain in High Risk Populations: Implementing the Centers for Disease Control Guideline (CDC) Guideline in the Primary Care HIV Clinic.

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2018年10月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
1
主要终点
Proportion of eligible PCPs who successfully complete randomization

研究概览

简要总结

The overarching plan for TOWER is to develop and test an algorithmic version of the Center for Disease Control Guidelines (CDCG) tailored for a specific primary care setting, the HIV primary care clinic. This CDCG intervention incorporates communication and implementation strategies tailored for the HIV primary care setting, and enabled with technology (an app for use by patients and EMR tools for providers).

详细描述

However, according to a 2014 AHRQ report, there have been no studies evaluating the effectiveness of any prescription opioid risk mitigation strategies. Furthermore, due to ambiguity in some of the CDCG recommendations and the challenging nature of the patient-provider opioid conversation, the success of the CDCG may hinge on the manner in which it is implemented in individual care settings. Thus it is unclear what the true effect of the CDCG will be. The investigators believe that for the CDCG to have the greatest likelihood of achieving its goals of improving prescription opioid safety without causing unintended effects (e.g. exacerbation of pain, disruption of other aspects of care), its recommendations will need to be skillfully communicated. Furthermore, because of this "human element"and other sources of variability, documenting the effectiveness of the CDCG will require standardization of implementation. The overarching plan for TOWER is to develop and test an algorithmic version of the CDCG tailored for a specific primary care setting, the HIV primary care clinic. This CDCG intervention incorporates communication and implementation strategies tailored for the HIV primary care setting, and enabled with technology (an app for use by patients and EMR tools for providers). Achieving this goal has involved soliciting input from the HIV community using the method of Public Deliberation (PD) in the setting of two Citizen' s Panels, each with ~22 HIV-infected participants and lasting one day; and using the information obtained from the deliberative process to inform the development of the CDCG intervention. The investigators now plan to test the CDCG intervention for feasibility.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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

  • Attending physician or advance practice provider in one of the Institute of Advanced Medicine (IAM) clinics
  • Designated PCP for at least 5 patients to whom he/she prescribes opioids
  • Willing and able to adhere to study procedures including randomization, and refraining from discussion of study procedures with other clinical staff or patients

排除标准

  • Unwillingness to undergo randomization
  • Plans to leave IAM within the study period.

结局指标

主要结局

Proportion of eligible PCPs who successfully complete randomization

时间窗: 18 months

Feasibility of recruitment and randomization of PCPs, reflected by the proportion of eligible PCPs who successfully complete randomization (where the denominator is the total number of PCPs offered participation).

次要结局

  • Percentage of items in the CDCG intervention which were adhered to(18 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jessica Robinson-Papp

Associate Professor

Icahn School of Medicine at Mount Sinai

研究点 (1)

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