Empowerment Program for Spinal Cord Injury

Overseen By Barbara W Trautner, MD PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Non-veterans, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

Antimicrobial resistance is a major public health concern that worsens healthcare outcomes. Antibiotic resistant organisms occur more often in Veterans with spinal cord injury or disease (SCI/D) given their frequent exposure to antibiotics, recurrent hospitalizations, and common use of urinary catheter devices. Veterans with SCI/D are also at risk for overtreatment with antibiotics when they do not need them, particularly for over-diagnosed urinary tract infections. The investigators plan to create a patient empowerment program with input of Veterans with SCI/D \[and their providers\] to help guide their decisions and next steps when they have a change in bladder symptoms. The program will give Veterans with SCI/D the tools to speak up to their provider and advocate for themselves to avoid receiving unnecessary antibiotics. This program is highly innovative, as it puts Veterans with SCI/D in charge of thoughtful antibiotic use, or antibiotic stewardship.

Who Is on the Research Team?

Eva Amenta, MD

Principal Investigator

Michael E. DeBakey VA Medical Center, Houston, TX

Are You a Good Fit for This Trial?

Inclusion Criteria

Participants must not have been involved in the development phase of the program

Participants must have access to a telephone

I am a veteran with a spinal cord injury and neurogenic bladder, and I had at least one UTI treated in the past year.

Exclusion Criteria

Non-Veterans

Veterans without SCI/D or neurogenic bladder

Patients who do not receive primary care at the MEDVAMC

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pilot Program

Veterans with SCI/D and neurogenic bladder participate in the empowerment program, including role-playing activities and marketing materials

12 months

Monthly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after the pilot program

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Empowerment Program

How Is the Trial Designed?

Group I: Pilot Program Participant Experimental Treatment 1 Intervention

Veterans with SCI/D and neurogenic bladder

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+