Cervical Spinal Cord Injury, Tetraplegia
Conditions
Keywords
Nerve Transfer Surgery, Tendon Transfer Surgery, Decision Support Intervention
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.
Interventions
OTHERSurveys 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.
Sponsors
United States Department of Defense
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed