Supporting Patient Decisions About UE Surgery in Cervical SCI

Not Applicable

Completed

• Conditions: Cervical Spinal Cord Injury

• Registration Number: NCT03464409
• Lead Sponsor: Washington University School of Medicine

Brief Summary

The goal of this study is to collect and describe patient and caregiver reported outcomes regarding surgical and non-surgical treatment for improving hand and arm function in the setting of cervical spinal cord injury. Eligible study participants will be recruited across the 4 sites and the investigators plan to recruit the following groups and numbers of participants:

1. Nerve or tendon transfer recipients: people who have elected to undergo nerve (N=10) or tendon (N=10) transfer surgery to restore some hand and arm function as part of their standard clinical care and their caregiver (N=20)

2. Non-surgical control group: people with cervical SCI (N=20) and their caregiver (N=20)

Detailed Description

At present, there is limited information that provides the exact time course and probability of gain in specific function (such as hand function) that might help patients and clinicians make decisions regarding novel and time-sensitive surgical treatment options.

Understanding the pros and cons of any surgical intervention, especially in the setting of complex and often incomplete information, is challenging. Ultimately, this project will create a decision support intervention (DSI) that can be used to help clinicians and people living with cervical level SCI and their caregivers. It will be most useful to those with acute or sub-acute injury (\< 1year after SCI) for both military personnel and the general public. Clinicians and patients will have evidence to help them make decisions about treatments to improve upper extremity function.

In such a manner, patients can make more well-informed choices that are consistent with their values, needs and goals.

Study Timeline

• Study First Submitted: 2018-03-07
• Study First Submitted QC: 2018-03-07
• Study Start: 2018-03-13
• Study First Posted: 2018-03-14
• Primary Completion: 2021-08-30
• Study Completion: 2021-08-30
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-01
• Last Update Posted: 2021-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Qualitative (interview) Analysis	24 months	All interviews will be transcribed verbatim and analyzed using standard qualitative text analysis. Members of the research team will read the transcripts for accuracy and to determine potential topics for coding. The investigators will develop a codebook using inductive and deductive codes. Deductive codes will be directly linked to our research questions. Adding inductive codes, where topics and codes are not pre-determined but are derived directly from the data, will allow the research team to develop a sense of how patients experience the surgical process, and allows for unexpected findings to emerge. Once the codebook is determined, two members of the research team will code the transcripts. Codes will be compared between raters. The investigators will use the codes to infer themes in the data.

Secondary Outcome Measures

Name	Time	Method
Quantitative (survey) Data Analysis	24 months	The data analysis will be conducted within each group. To account for correlations among repeated measures from the same patient, the longitudinal data will be analyzed using a mixed model to examine the change in survey outcomes.

Trial Locations

Locations (4)

Veterans Affairs Palo Alto Health Care System; 🇺🇸 Palo Alto, California, United States

Stanford University; 🇺🇸 Stanford, California, United States

Veterans Affairs St. Louis Health Care System; 🇺🇸 Saint Louis, Missouri, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States