NCT04995796

Testing the Decision Aid: Supporting Patient Decisions About Upper Extremity Surgery in Cervical SCI

Testing the Decision Aid: Supporting Patient Decisions About Upper Extremity Surgery in Cervical Spinal Cord Injury (AIM 3)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cervical Spinal Cord Injury
• Tetraplegia

Interventions

Type	Name	Description
OTHER	Surveys for Research Purposes	VISIT #1: 1. Pre-Testing: * Pre Knowledge Test * Pre SURE (decisional conflict) test 2. Independent DSI/DA Interaction 3. Post-Testing: * Post Knowledge Test * Post SURE (decisional conflict) Test * Acceptability Index * Modified Single Item Literacy Screen * Additional Demographics VISIT #2: Check-In Call 1 week later: After viewing the DSI/DA and completing the post-test components above, the subjects will also complete a 5 minute debrief interview about 1 week later via phone or video conference with a team member to give feedback on their experience using the DSI/DA, including its strengths and weaknesses. This will allow for further improvement and refinement of the DSI.

Timeline

• Start date: 2021-12-01
• Primary completion: 2022-08-22
• Completion: 2022-08-22
• First posted: 2021-08-09
• Last updated: 2022-08-24

Locations

1 site across 1 country: United States