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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Tetraplegia, Cervical Spinal Cord Injury

Intervention / Treatment
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* Other: Surveys for Research Purposes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 1) Previous treatment with nerve or tendon transfer surgery.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, single arm pre/post pilot study. This non-therapeutic study will provide no direct medical benefit to the research participants but will help the researchers learn more so that future generations may benefit.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enrolled Participants<br>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. | Other: Surveys for Research Purposes<br>* VISIT #1: Pre-Testing: Pre Knowledge Test Pre SURE (decisional conflict) test Independent DSI/DA Interaction 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge Questionnaire | 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. | At baseline and then immediately after reviewing the Decision Aid (estimated to be around 60-90 minutes later). | 
| Decisional Conflict Questionnaire | 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. | At baseline and then immediately after reviewing the Decision Aid (estimated to be around 60-90 minutes later). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire to Assess the Acceptability of 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. | Immediately after reviewing the Decision Aid. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nerve Transfer Surgery, Tendon Transfer Surgery, Decision Support Intervention