Testing the Decision Aid: Supporting Patient Decisions About Upper Extremity Surgery in Cervical Spinal Cord Injury (AIM 3)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Knowledge Questionnaire
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Previous treatment with nerve or tendon transfer surgery.
Arms & Interventions
Enrolled Participants
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.
Intervention: Surveys for Research Purposes (Other)
Outcomes
Primary Outcomes
Knowledge Questionnaire
Time Frame: 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
Time Frame: 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 Outcomes
- Questionnaire to Assess the Acceptability of the Decision Aid(Immediately after reviewing the Decision Aid.)
Investigators
Ida Fox
Associate Professor of Surgery
Washington University School of Medicine