跳至主要内容
临床试验/NCT07202026
NCT07202026Enrolling By Invitation不适用

Patient Perspectives on Prescription Opioid Discontinuation: Understanding and Promoting Safe Transitions

Kaiser Permanente2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年10月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
30
试验地点
2
主要终点
Acceptability of DA

研究概览

简要总结

Because of recent policies to decrease opioid use, some people using long-term opioid therapy (LTOT) are encouraged or required to stop (discontinue) taking opioids. That has led experts to be concerned that patients whose LTOT is discontinued could have untreated pain, turn to other substance use and possibly illicit opioids, or have worsened mental health symptoms leading to suicide. To guide safer policies, guidelines, and care, this study will interview patients and doctors about discontinuing LTOT and use the results to develop a patient-centered decision aid (DA) to improve patient-provider communication around discontinuation of LTOT. Once the DA is finalized, it will be pilot tested with a group of 30 patients who are currently on LTOT. The pilot will assess DA implementation feasibility; acceptability; knowledge transfer; and ability to successfully foster positive, patient-centered conversations about opioid discontinuation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
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
否

入选标准

  • •EHR-based inclusion criteria:
  • •age 18 or older
  • •LTOT in the past 18 months (LTOT is ≥60 days of ≥50 MEDs day in each of 2 consecutive 90-day periods with medication treatment for OUD excluded)
  • •Inclusion criteria confirmed by participant
  • •Have been taking opioids for chronic pain for at least 6 months
  • •Able to speak and read English

排除标准

  • •cancer diagnosis in the last 5 years (excluding non-melanoma skin cancers)
  • •current palliative or hospice care
  • •cognitive disability
  • •psychiatric hospitalization in the last year
  • •surgery in the last 6 months
  • •current residence in an inpatient rehabilitation or skilled nursing facility
  • •Exclusion criteria determined by study
  • •- participated in an interview for Aim 1 of this study

研究组 & 干预措施

Decision Aid Pilot Test

Experimental

干预措施: Patient-centered Decision Aid to support long-term opioid therapy tapering (Behavioral)

结局指标

主要结局

Acceptability of DA

时间窗: 1-2 weeks

We will use Matlock et al.'s acceptability ranking scale to assess the acceptability of the DA to patients

Acceptability of DA

时间窗: 1-2 weeks

We will use Matlock et al.'s acceptability ranking scale to assess the acceptability of the DA to patients

次要结局

未报告次要终点

研究者

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

Clarissa Hsu

Associate Investigator

Kaiser Permanente

研究点 (2)

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