A Digital Patient Decision Aid to Increase Sexually Transmitted Infection Testing in the Emergency Department: The STIckER Study

Study Overview
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Brief Summary
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This study is a pilot randomized trial of STIckER in which 40 providers (20 trained in using the STIckER decision aid and 20 providing standard care) will enroll a total of 140 sexually active young Emergency Department (ED) patients over six months in a pediatric and adult ED setting. The primary goal is to determine if sexually active young individuals who use STIckER are more likely to undergo STI testing. By developing an effective automated digital tool to increase STI testing, the investigators aim to improve evidence-based sexual health education, reduce STI rates, and enhance the health outcomes of young individuals nationwide.

Detailed Description
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Improving sexually transmitted infection (STI) screening is vital to combat the STI epidemic, especially among adolescents and young adults (AYA) aged 15-24 years in the United States. Inadequate testing for STIs in different body areas contributes to disease transmission. Emergency Departments (EDs) treat a significant number of young individuals, many of whom come from economically disadvantaged backgrounds and minority communities. Previous research has shown inconsistent use of contraception in this population, and despite the willingness of ED providers to support sexual health interventions, time and resource limitations present implementation challenges. To address this issue, the investigators propose developing STIckER (STI ChecK in the ER), a digital patient decision aid for STI testing in the ED that promotes shared decision-making. STIckER involves three steps: (1) patients complete a nonjudgmental sexual health screening assessment by scanning a quick-response (QR) code, (2) educational modules facilitate shared decision-making (SDM) by connecting personalized STI risk with evidence-based testing recommendations, and (3) a confidential, color-coded digital infographic aids the patient-provider discussion on STI testing.

Official Title
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A Digital Patient Decision Aid to Increase Sexually Transmitted Infection Testing in the Emergency Department: The STIckER Study

Conditions
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STI, Sexually Transmitted Disease (STD), Sexually Transmitted Infection (STI)

Intervention / Treatment
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* Behavioral: STIckER
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: AYA aged 14-24 years Sexually active within the past 6 months (per self-report) Ability to speak English Exclusion criteria: Severe illness Cognitive impairment Inability to speak English

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Individuals will be randomized into the control arm (standard of care) or STIckER arm to receive the intervention.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control<br>After enrollment but before the start of their clinical visit, participants assigned to a provider in the control arm will scan a QR code. They will receive a prompt stating, If you would like to be tested for a sexually transmitted infection today, please tell your medical doctor. At the end of the visit, the participant will complete the Patient Control Exit Survey while the provider will complete the Provider Control Exit Survey. These participants will not receive STIckER training. | Other: Control<br>* After enrollment but before the start of their clinical visit, AYA participants assigned to a provider in the control arm will scan a QR code. They will receive a prompt stating, If you would like to be tested for a sexually transmitted infection today, please tell your medical doctor.<br>|
| Experimental: STIckER<br>After enrollment but before the start of their clinical visit, participants assigned to a provider in the intervention arm will scan a QR code using their personal mobile phone at the start of their ED visit. If they do not have a mobile phone present, a secure password-protected tablet will be provided by the research staff. This will lead them to go through the STIckER decision aid modules. After completing the modules, participants will show the final outcome to their ED provider which may facilitate an SDM conversation about STI testing. At the end of the visit, the participant will complete the Patient Intervention Exit Survey while the provider will complete the Provider Intervention Exit Survey. | Behavioral: STIckER<br>* STIckER is an interactive and personalized intervention based on the principles of SDM that has been designed with input from the AYA ED patients and providers. STIckER guides AYA patients through a series of steps, beginning with scanning your STIckER. Participants complete risk assessments, SDM modules, and conclude with an anonymous final digital infographic that informs an SDM conversation with the medical provider. This decision aid seamlessly integrates into the ED workflow, recommending appropriate STI testing for high-risk individuals and using SDM concepts for those at intermediate risk.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ED STI Testing Rate | Percent of individuals with any gonorrhea or chlamydia testing performed in the ED on the day of their STIckER visit. | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extragenital STI testing Rate | Percent of individuals with any gonorrhea or chlamydia extra-genital (pharyngeal or rectal) test performed in the ED on the day of their STIckER visit. | Day 0 | 
| Genitourinary STI testing Rate | Percent of individuals with any gonorrhea or chlamydia genitourinary test performed in the ED on the day of their STIckER visit. | Day 0 | 
| STI Positivity Rate | Percent of individuals testing positive for gonorrhea or chlamydia at any site. | Day 0 | 
| Acceptability of Intervention Measure (AIM) Score | Acceptability assessed by a four item questionnaire with each question scored from 1 (completely disagree) to 5 (completely agree). Scores to each question are averaged to determine a mean score, ranging from 1 (minimum) to 5 (maximum), with a higher score indicating a better outcome. | At completion of all patient visits (within 6 months of enrollment) | 
| Intervention Appropriateness Measure (IAM) Score | Appropriateness assessed by a four item questionnaire with each question scored from 1 (completely disagree) to 5 (completely agree). Scores to each question are averaged to determine a mean score, ranging from 1 (minimum) to 5 (maximum), with a higher score indicating a better outcome. | At completion of all patient visits (within 6 months of enrollment) | 
| Feasibility of Intervention Measure (FIM) Score | Feasibility assessed by a four item questionnaire with each question scored from 1 (completely disagree) to 5 (completely agree). Scores to each question are averaged to determine a mean score, ranging from 1 (minimum) to 5 (maximum), with a higher score indicating a better outcome. | At completion of all patient visits (within 6 months of enrollment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gonorrhea, Chlamydia