Testing the Decision Aid: Supporting Patient Decisions About Upper Extremity Surgery in Cervical Spinal Cord Injury (AIM 3)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Knowledge Questionnaire
研究概览
简要总结
Purpose: The objective of this study is to assess a newly created decision support intervention (DSI) or decision aid (DA) for people with spinal cord injury (SCI) to learn about and consider upper extremity reconstructive surgery to help them choose a course of treatment that most aligns with their values.
详细描述
The overarching aim of this project is to define key information about improvement of upper extremity function after SCI (time and extent of recovery, outcome of surgical and non-surgical interventions and the experience thereof) and communicate this information to patients and clinicians to support their treatment decisions.
This particular Aim 3 of the overall project will assess a newly developed DSI/DA tool in a pre-/post- pilot study of people with SCI hoping to restore upper extremity function in cervical SCI. Using information from prior aims of this project, a de novo tool has been created and will be tested. This study will measure participant knowledge of their condition and treatment options, and decisional conflict. Participant feedback, demographics, and health-literacy information will be collected to help improve and refine the DA before it is made widely available to the public.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subjects (≥18 years to ≤80 years) with mid-cervical level SCI (minimum 6 months and maximum 20 years post-injury).
- •Must have limited use of their hands.
- •Wheelchair dependent for mobility.
- •Ability to read, speak and understand English.
排除标准
- •Previous treatment with nerve or tendon transfer surgery.
结局指标
主要结局
Knowledge Questionnaire
时间窗: At baseline and then immediately after reviewing the Decision Aid (estimated to be around 60-90 minutes later).
An online, novel, 10-question knowledge survey will provide information about the Decision Aid's effect on patient understanding of their condition, treatment options, and probability of recovery. This questionnaire will be administered as a "Pre-Test" before participants view the Decision Aid, and then later as a "Post-Test" after participants view the Decision Aid. Hypothesis: Use of the DSI/DA framework will change participants' knowledge about SCI and treatment options for people living with cervical SCI.
Decisional Conflict Questionnaire
时间窗: At baseline and then immediately after reviewing the Decision Aid (estimated to be around 60-90 minutes later).
An online questionnaire of 4 questions that are slightly modified, but based on the standardized, validated survey instrument called the SURE Test (of decisional conflict). This questionnaire will be administered as a "Pre-Test" before participants view the Decision Aid, and then later as a "Post-Test" after participants view the Decision Aid. Hypothesis: Participants will experience a change in decisional conflict when they think about improving arm and hand function in the setting of cervical spinal cord injury and consider the treatment options that they might prefer.
次要结局
- Questionnaire to Assess the Acceptability of the Decision Aid(Immediately after reviewing the Decision Aid.)
研究者
Ida Fox
Associate Professor of Surgery
Washington University School of Medicine