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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04995796
Recruitment Status : Completed
First Posted : August 9, 2021
Last Update Posted : August 24, 2022
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Ida Fox, Washington University School of Medicine

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cervical Spinal Cord Injury Tetraplegia Other: Surveys for Research Purposes Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Testing the Decision Aid: Supporting Patient Decisions About Upper Extremity Surgery in Cervical Spinal Cord Injury (AIM 3)
Actual Study Start Date : December 1, 2021
Actual Primary Completion Date : August 22, 2022
Actual Study Completion Date : August 22, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Other: Surveys 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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04995796


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
United States Department of Defense
Investigators
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Principal Investigator: Ida K Fox, MD Washington University School of Medicine
More Information
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Publications:

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Responsible Party: Ida Fox, Associate Professor of Surgery, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04995796    
Other Study ID Numbers: 202106018
First Posted: August 9, 2021    Key Record Dates
Last Update Posted: August 24, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ida Fox, Washington University School of Medicine:
Nerve Transfer Surgery
Tendon Transfer Surgery
Decision Support Intervention
Additional relevant MeSH terms:
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Spinal Cord Injuries
Quadriplegia
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
 Trauma, Nervous System
Wounds and Injuries
Paralysis
Neurologic Manifestations