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

The Washington University

Status: Completed

Conditions: Tetraplegia; Cervical Spinal Cord Injury

Treatments: Other: Surveys for Research Purposes

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04995796

202106018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult subjects (≥18 years to ≤80 years) with mid-cervical level SCI (minimum 6 months and maximum 20 years post-injury).
2. Must have limited use of their hands.
3. Wheelchair dependent for mobility.
4. Ability to read, speak and understand English.

Exclusion criteria

1. Previous treatment with nerve or tendon transfer surgery.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Enrolled Participants

Experimental group

Description:

Study participation will involve 2 visits. The first visit will take approximately 90 minutes, but may be longer if participant desires longer interaction with the DSI/DA. The second visit will take approximately 5 minutes.

Treatment:

Other: Surveys for Research Purposes