Empowerment Program to Reduce Treatment of Asymptomatic Bacteriuria in Veterans With Spinal Cord Injury

Direct to Consumer Empowerment Program to Reduce Treatment of Asymptomatic Bacteriuria in Veterans With Spinal Cord Injury and Neurogenic Bladder

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Spinal Cord Injury; Spinal Cord Disease
• Intervention / Treatment: Behavioral: Empowerment Program

Detailed Description

It is estimated that 42,000 Veterans are living with spinal cord injury or disease (SCI/D), 27,000 of whom are cared for by the VA each year. Individuals with SCI/D and neurogenic bladder are at increased risk for infections from antibiotic-resistant bacteria due to many factors, including repeated exposure to healthcare settings, healthcare-associated pathogens, and antibiotics, as well as the frequent presence of medical devices (e.g., urinary catheters).] These issues are a cause for concern, as rising rates of antibiotic resistance are a major public health issue, and healthcare outcomes are worse in patients with infections from antibiotic-resistant organisms. A primary reason for high rates of antibiotic usage among those with SCI/D and neurogenic bladder is bacterial colonization of the bladder (i.e., bacteriuria), which is common in these individuals due to urinary retention and urinary catheters and often treated with antibiotics despite guidelines recommending against this practice. In particular, treatment of bladder colonization without signs/symptoms of infection, known as asymptomatic bacteriuria (ASB), is not recommended as antibiotics do not improve clinical outcomes and contribute to antibiotic resistance. However, despite efforts to reduce the frequency of treatment for ASB among providers, treatment rates remain high, and nearly half of the courses of antibiotics prescribed for suspected UTIs in those with neurogenic bladders are for the inappropriate treatment of ASB.

Innovation and Impact: The investigators propose to address this problem by developing an empowerment intervention for Veterans with SCI/D and neurogenic bladder to help them interact with their providers about their bladder health and advocate for themselves when they do not need antibiotics. This intervention will include direct-to-consumer marketing material to engage Veterans with SCI/D and empowerment training via role-playing for Veterans to use when discussing suspected UTI with their providers. Specific Aims: The investigators will develop and pilot this Veteran-focused, Veteran-led antibiotic stewardship program through a mixed-methods research design.

The investigators will pilot test the direct-to-consumer patient empowerment program, role-playing activities, and marketing materials among Veterans with SCI/D and neurogenic bladders and their providers.

Methodology: This study employs qualitative and quantitative data techniques, such as semi-structured interviews, focus groups, quantitative surveys and outcome measures, and a pilot study. The primary outcome of the pilot study is the assessment of Veterans' self-reported quality of life specific to urinary incontinence via the Incontinence Quality of Life Questionnaire. Secondary outcomes include bladder symptom burden via Neurogenic Bladder Symptom Score, feasibility and acceptability of the intervention to Veterans with SCI/D via the Weiner survey, functional outcomes (with emphasis on bladder function), knowledge and attitudes about antibiotics, communication with providers, and response to marketing materials. Path to Translation/ Implementation: This work will lay the groundwork for a future randomized controlled trial testing the program's effectiveness at reducing unnecessary antibiotic treatment of ASB in Veterans with SCI/D. More broadly, empowering Veterans and their caregivers to engage with their providers and advocate for their health is integral to the PI's long-term goal of becoming a VA clinician-investigator recognized for advancing innovative approaches to antimicrobial stewardship in rehabilitation populations.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eva Amenta, MD; Phone Number: (713) 440-4400; Email: eva.amenta@va.gov
• Study Contact Backup: Name: Barbara W Trautner, MD PhD; Phone Number: (713) 440-4438; Email: barbara.trautner@va.gov

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030-4211
      • Michael E. DeBakey VA Medical Center, Houston, TX
      • Contact: Eva Amenta, MD; Phone Number: 713-440-4400; Email: eva.amenta@va.gov
      • Principal Investigator: Eva Amenta, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Veterans with SCI/D and neurogenic bladders who have been treated for at least one UTI in the past year
• Have access to a telephone
• Have not been involved in the development phase of the program

Exclusion Criteria:

• Non-Veterans
• Veterans without SCI/D or neurogenic bladder
• Patients with dementia who would not be able to provide consent or respond to interview prompts
• Patients who do not receive primary care at the MEDVAMC
• Veterans who participated in the development of the empowerment program

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Pilot Program Participant; Veterans with SCI/D and neurogenic bladder

Behavioral: Empowerment Program; Enrolled participants will receive the program via email and/or mail. In addition, participants will be contacted by a member of the research team to conduct empowerment training. This training will entail walking the participant through the training manual and each of the program's materials. Training will also include an access plan for Veterans to employ when they have genitourinary symptoms and education on how to use the bladder symptom-assessment decision-support aid (the MedStar Urinary Symptom Questionnaire bladder symptom-assessment tool). The access plan will suggest that the Veteran review the empowerment program when they have concerning genitourinary symptoms and decide how they will contact their provider or health care nurse. In addition, a time will be set up for participants to engage in role-playing with a member of the research team to trial the use of the empowerment tool as it should be used in a clinical setting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Incontinence Quality of Life Questionnaire	Scoring: 28-item survey on a 4-point Likert scale with higher number being associated with better quality of life	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurogenic Bladder Symptom Score	A 24-item questionnaire that measures bladder symptoms over three domains; graded on a 4-point Likert scale. higher scores are associated with worse symptom burden or quality of life	12 months
The Spinal Cord Injury - Quality of Life (SCI-QOL) survey	An 8-question short-form survey on a five-point Likert scale; higher scores indicate more bladder management difficulties	12 months
Chew's Health Literacy Survey	A three-question survey that is scored on a five-point Likert scale, with a maximum score of 15 and a minimum score of 3; higher scores correlate to poor health literacy and low scores indicate high health literacy.	6 months
Knowledge and Attitudes about Antibiotics	Modeled off the WHO Multi-country antibiotic awareness campaign as well as a survey used for attitudes and behavior surrounding antibiotic use in providers of SCI/D developed by Skelton et al. - This is a single survey. For attitudes and Behavior questions scal goes from strongly disagree to strongly agree with lower scores associated with disagreement. Knowledge will be measured based on responses to questions with less or incorrect answers associated with less knowledge.	12 months
Weiner tool Feasibility and acceptability subscales for the empowerment program	An eight-question survey scored on a five-point Likert scale, higher scores indicate the intervention is feasible to use and acceptable. Scoring Instructions: Scales can be created for each measure by averaging responses. Scale values range from 1 to 5. No items need to be reverse coded. Lower scores are associated with less acceptability or feasibility.	12 months
Communication with Physicians survey	Three questions urevey on a 5-point Likert scale. Score each item as the number circled. If more than one consecutive number is circled, code the lower number (less communication). If the numbers are not consecutive, do not score the item. The score is the mean of the three items. If more than one is missing, set the value of the score for the scale to missing. A higher score indicates better communication with physicians.	12 months
Self-Regulation Assessment	A 22-question survey scored on a five-point Likert scale; higher scores correspond to higher levels of self-regulation	12 months
Clinical Chart Review	Conducted monthly through the time of patient study participation to assess clinic calls about urinary complaints	12 months
Consent Rates	Consent rates will be measured as a form of feasibility and acceptability	12 months
Clinical Chart Review (clinic visits)	Conducted monthly through the time of patient study participation to assess clinic visits	12 months
Clinical Chart Review (ER visits)	Conducted monthly through the time of patient study participation to assess ER visits	12 months
Clinical Chart Review (hospitalization for UTI)	Conducted monthly through the time of patient study participation to assess hospitalization for UTI	12 months
Clinical Chart Review (antibiotic prescriptions ordered for ASB or UTI)	Conducted monthly through the time of patient study participation to assess antibiotic prescriptions ordered for ASB or UTI	12 months
Completion Rate	Completion rates will be measured as a form of feasibility and acceptability	12 months

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Eva Amenta, MD, Michael E. DeBakey VA Medical Center, Houston, TX

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): June 30, 2032

Study Registration Dates

• First Submitted: February 17, 2026
• First Submitted That Met QC Criteria: February 17, 2026
• First Posted (Actual): February 24, 2026

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Spinal Cord Injury; Neurogenic Bladder; Spinal Cord Disease; Antimicrobial Stewardship; Asymptomatic Bacteriuria; Veteran Healthcare
• Additional Relevant MeSH Terms: Urogenital Diseases; Neurologic Manifestations; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Trauma, Nervous System; Urinary Bladder Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Spinal Cord Injuries; Urinary Bladder, Neurogenic; Spinal Cord Diseases
• Other Study ID Numbers: RRD9-004-25M; 1IK2RD002113-01A2 (Other Grant/Funding Number: RRD&T)

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
• product manufactured in and exported from the U.S.: No