Medication Safety Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 2
- 主要终点
- Self-efficacy - 8 Item Measure Taps Into Key Concepts Associated With Confidence for Managing Opioid Medications
研究概览
简要总结
The purpose of this project is to test whether an online pain medication intervention is a feasible and effective way to increase opioid pain medication safety.
详细描述
The goal of the study is to test the efficacy of the pain medication safety intervention for increasing safe management of prescription medication opioids. The study will use a randomized, controlled design that compares the intervention (painACTION medication safety lessons) to a waitlist control condition.
The hypotheses related to efficacy are that, as compared to the control group, people in the experimental group will demonstrate:
- Increased self-efficacy for how to safely manage medications (primary outcome)
- Increased behaviors associated with safely managing medication (secondary outcome)
Participants:
Investigators will recruit the first 148 respondents who meet the inclusion criteria and consent to be in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be willing and able to provide consent
- •Have the ability to read and write English
- •Diagnosis of non-cancer chronic pain
- •Prescribed opioids and taking consistently for 3 months.
- •Over 18 years old
排除标准
- •Previously visited painACTION
结局指标
主要结局
Self-efficacy - 8 Item Measure Taps Into Key Concepts Associated With Confidence for Managing Opioid Medications
时间窗: Baseline - Day 1, Posttest - Day 16 (intervention took 15 days), One month Followup - at 1 month post-intervention
Responses are measured on a 4-point Likert scale (1= "Not at all confident" and 4= "Extremely confident"). The total Score range:8=least confident, 32=most confident. How confident do you feel in your ability to do each of the following activities, today? 1. I can recognize side effects that are related to my opioid medicine. 2. I can avoid giving my opioid medicine to someone else. Etc.. 1 - Not at all confident 2 - Somewhat confident 3 - Very confident 4 - Extremely confident Items have been generated from literature. Content validity: assessed by asking two experts if items are important and relevant. Internal consistency of the items in the pilot measure will be assessed (Cronbach's alpha). Test-retest reliability will be explored by asking 50 participants in the control group to retake the pilot measure within 3-5 days of having taken the measure as part of the pretest.
次要结局
- Satisfaction With the Program(One-month followup assessment)