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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Empowerment Program

    Behavioral

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Pilot Program ParticipantExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
12 months

Secondary outcomes

1

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

Time frame
12 months
2

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

Time frame
12 months
3

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.

Time frame
6 months
4

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.

Time frame
12 months

Other outcomes

Sponsors and contacts

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