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临床试验/NCT04998734
NCT04998734终止不适用

ASI-SR Form as a Standardized Instrument for Healthcare Management of Chronic Non-cancer Pain Patients

Uppsala University1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2021年8月5日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
1
试验地点
1
主要终点
Addiction Severity Index - Short version

研究概览

简要总结

The Swedish version of ASI-SR has shown good feasibility in assessment of addiction patients functioning compare to long and time-consuming ASI, which is upp to date golden standard in Sweden. This study investigate if ASI-SR is suitable instrument for the assessment of the chronic pain patient addicted to opioids. The validation process is designed according to the COSMIN guidelines.

Preliminary results are expected by December 2022.

详细描述

The use of opioids in treatment of chronic non- cancer pain (CNCP) has increased during the past decades in most parts of the western world. Use of prescription opioids can lead to problematic opioid use which can be life-threatening with significant morbidity and mortality. Studies have found that 21-29% of CNCP patients receiving chronic opioid therapy (COT) ( receiving opioids for > 90 days) have problematic opioid use. Individuals with chronic pain and co-occurring substance use disorders and/or mental health disorders, have increased risk for problematic use of prescribed opioids.

Several screening instruments and strategies have been introduced in recent years for identifying patients not suitable for opioid therapy. Even so, there is no single test or instrument that can reliably identify those patients at risk for developing problematic opioid use or opioid use disorder if opioid therapy is initiated, or identify those who need increased monitoring during treatment.

Addiction Severity Index (ASI) is a standardized semi-structured interview used for assessing severity and need of treatment in seven functional domains associated to substance use disorders; physical health, employment/support status, alcohol use, drug use, legal status, family/social functioning and psychiatric health. The ASI was developed in the US. by McLellan and colleagues and is widely used all over the world, both in research and for clinical assessment and treatment evaluations . The ASI could be a useful instrument for a multidimensional assessment of patients with chronic non-cancer where opioid treatment is considered, and it could also be used for evaluation of ongoing opioid therapy . However, the ASI interview is a time consuming instrument. To conduct an interview takes between 45-60 minutes and is followed by 20-25 minutes of administrative work. In the year of 2000 Rosen et al tested a short self-report form based the items used to calculate the ASI composite scores that asses current function and problem severity. This questionnaire was translated by our research group and tested on a sample of individuals referred to the Addiction clinic at Uppsala University Hospital. The study suggested that a self-administered questionnaire based on the subscales of the ASI composite scores is a feasible alternative to the ASI interview for assessing patient functioning in the different domains and screen for current problematic alcohol- or drug use .

A validated screening tool that provides both an effective method of assessing patients and identifying problems in several different life domains, and identify substance use related problems if they should arise, would be beneficial in clinical practice when deciding what treatment to offer. Such an instrument could potentially decrease the risk of iatrogenic opioid use disorder.

Purpose and aims The main objective with this study is to test the psychometric properties of the ASI-SR in a population of CNCP patients. 'Secondary aim is to describe differences between subjects treated within the substitution therapy program and those who are treated within the pain clinic.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic non-cancer related pain
  • ongoing treatment in the clinic

排除标准

  • severe cognitive impairment
  • illiterate in Swedish
  • inability to give informed consent.

结局指标

主要结局

Addiction Severity Index - Short version

时间窗: Baseline

The main objective with this study is to test the psychometric properties of the ASI-SR in a population of CNCP patients.Consistency of CS between the interview and the self-report will be evaluated on the individual basis by interclass correlation analysis (ICC) and at group level with paired t-test or Wilcoxon signed rank test if data is not normally distributed. ICC coefficient is considered to be poor if it is less than 0.40, fair between 0.40-0.59 , good between 0.60-0.70 and excellent between 0.75-1.00.

次要结局

  • Patient Global Impression of Change(Baseline)
  • Alcohol Use Disorder Identification Test(Baseline)
  • Patient Health Questionnaire PHQ9(Baseline)
  • Generalised Anxiety Disorder 7(baseline)
  • Research and Development 36-Item Health Survey RAND-36(Baseline)
  • Addiction Severity Index -Short version(4-7 days later)
  • Pain Disability Index(Baseline)
  • Drug Use Disorder Identification Test(Baseline)

研究者

发起方
Uppsala University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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