Evaluating FDA's Proposed Patient Medication Information Handout: A Randomized Trial Measuring Perceived Usefulness and Comprehension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 330
- 试验地点
- 2
- 主要终点
- Perceived difficulty or ease in reading information
研究概览
简要总结
The goal of this study is to assess how useful the proposed one-page FDA-template PMI is to potential users.
The main questions it aims to answer are:
How does the proposed one-page FDA-template PMI compare with the current drug information insert in terms of usefulness and comprehension?
and
How does the proposed one-page FDA-template PMI compare with a revision adding drug benefit information?
Participants will randomized to review one of three patient medication information sheets and then asked questions related to usefulness and comprehension.
详细描述
The US Food and Drug Administration (FDA) has proposed a new one-page 'patient medication information (PMI) handout that can be provided with every prescription medication, in order to provide patients with the information they need to use their medications safely and effectively. The current proposal omits some decision-critical benefit information and had not been tested with potential users, potentially undermining its effectiveness.
The goal of this study is to assess how useful the proposed one-page FDA-template PMI is to potential users, compared with a revision adding drug benefit information and with the current drug information insert.
A randomized trial will be conducted with U.S. female adults 18-45 years, recruited in March, 2024. Participants will complete an online survey after being randomized to view 1 of the 3 information formats. Participants will be paid $10. Surveys are expected to take no more than 30 minutes to complete.
Participants will be randomized to receive either the one-page FDA-template PMI (FDA PMI), a modified template, which added information about drug benefits (Decision Critical PMI), or the existing drug information insert (standard drug information) for the drug, Mifeprex. All individuals will complete knowledge and usability questions and provide demographic information.
The main outcomes measured will be perceived usefulness and comprehension of the patient medication information.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •US geographic location
- •18-45 years of age
- •assigned female sex at birth
排除标准
- •<18 years of age
- •> 45 years of age
- •assigned a sex other than female at birth
结局指标
主要结局
Perceived difficulty or ease in reading information
时间窗: day 1
Single question with a 5-point likert scale response for "How easy or difficult was it to read the medication information guide about \[drug\]?" Minimum score is 1; Maximum score is 5. A higher score represents higher perceived usefulness.
Comprehension
时间窗: day 1
10 newly-constructed questions designed to measure the comprehension of the following information from the medication information guide: 1) Analysis of condition (1 question) 2) Risks (3 questions) 3)Risk Management (3 questions), and 5) Benefits (3 questions). Participants can score from 0-10 with 10 representing full comprehension of the information and 0 representing no comprehension of the information.
Perceived usefulness of the medication information guide in making a use decision
时间窗: day 1
Single question with a 5-point likert scale response for "For someone who had not yet decided to use \[drug\], how useful would the medication information guide be in helping them to make that decision?" Minimum score is 1. Maximum score is 5. A higher score represents higher perceived usefulness.
Perceived usefulness of the medication information guide in taking the medication properly
时间窗: day 1
Single question with a 5-point likert scale response for "If someone had decided to use \[drug\], how useful would the medication information guide about \[drug\] be in helping them use the drug properly? " Minimum score is 1. Maximum score is 5. A higher score represents higher perceived usefulness.
次要结局
- Strength of Evidence(day 1)
研究者
Baruch Fischhoff
University Professor
Carnegie Mellon University