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

Not Applicable

Completed

• Conditions: Cervical Spinal Cord Injury; Tetraplegia
• Interventions: Other: Surveys for Research Purposes

• Registration Number: NCT04995796
• Lead Sponsor: Washington University School of Medicine

Brief 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.

Study Timeline

• Study First Submitted: 2021-07-07
• Study First Submitted QC: 2021-08-03
• Study First Posted: 2021-08-09
• Study Start: 2021-12-01
• Status Verified: 2022-08
• Primary Completion: 2022-08-22
• Study Completion: 2022-08-22
• Last Update Submitted: 2022-08-22
• Last Update Posted: 2022-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Enrolled Participants	Surveys for Research Purposes	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.

Primary Outcome Measures

Name	Time	Method
Knowledge Questionnaire	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	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.

Secondary Outcome Measures

Name	Time	Method
Questionnaire to Assess the Acceptability of the Decision Aid	Immediately after reviewing the Decision Aid.	An online questionnaire (14 questions) based on 3 standardized, validated survey instruments called the Acceptability Index, the System Usability Scale (SUS) and the Single Item Literacy Screener (SILS).They have been slightly modified for use in this population. This aggregated approach will provide information about the participant's experience with the Decision Aid and provide feedback on the overall helpfulness and suitability of the novel Decision Aid. The questionnaire will be administered as a "Post-Test" after participants view the Decision Aid.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States