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

August 22, 2022 updated by: Ida Fox, Washington University School of Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: Ida K Fox, MD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Actual)

August 22, 2022

Study Completion (Actual)

August 22, 2022

Study Registration Dates

First Submitted

July 7, 2021

First Submitted That Met QC Criteria

August 3, 2021

First Posted (Actual)

August 9, 2021

Study Record Updates

Last Update Posted (Actual)

August 24, 2022

Last Update Submitted That Met QC Criteria

August 22, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202106018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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