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Completed

NCT Number: NCT04995796

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

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.

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Key information

Conditions

Cervical Spinal Cord Injury Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Quadriplegia Signs and Symptoms Tetraplegia

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Surveys for Research Purposes

Other

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.

Primary outcomes

  1. 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.

  2. 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

  1. Questionnaire to Assess the Acceptability of the Decision Aid

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 9, 2021
Registry last updated
Aug 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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