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Clinical Trials/NCT03502226
NCT03502226CompletedNot Applicable

Evaluation of an Inpatient Sexual Risk Behavior Assessment Program

Rhode Island Hospital0 sites66 target enrollmentStarted: January 4, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
66
Primary Endpoint
Number of participants with requests for sexual health services, as assessed by sexual health options questionnaire

Study Overview

Brief Summary

This is an exploratory pilot study to evaluate the feasibility and potential effects of an innovative, individualized electronic inpatient sexual health intervention (iRAP) for adolescent females. The central hypothesis is that the electronic intervention, a sexual health questionnaire with tailored feedback based on the Trans Theoretical Model (TTM) of behavior change, will significantly increase adolescent females' requests for sexually transmitted infection (STI) screening and sexual health management during their hospital admission.

Detailed Description

Sexually transmitted infections (STIs) are disproportionately common among 15-24 year-old females, and can have detrimental effects including pelvic inflammatory disease and infertility. Most STI's are asymptomatic, especially for females, making screening programs essential. Current guidelines recommend HIV screening for all adolescents, and yearly chlamydia and gonorrhea screening for sexually active females under 25 years-old. Yet only one-third of primary care physicians report screening asymptomatic adolescents. Most adolescents report no sexual health discussion during preventative healthcare visits. Furthermore the majority do not regularly attend preventative healthcare visits. Therefore, urgent healthcare visits, often in emergency departments (ED) and inpatient settings, provide an important point of contact.

Given adolescents infrequently obtain outpatient sexual health services, the inpatient stay may serve as a critical intervention point. Other studies have found success with STI screening programs in the ED; none to our knowledge examined the efficacy of an inpatient sexual health screening protocol. Previous pilot data demonstrated, however, significant interest in sexual health information and desire for STI testing among adolescents admitted to a children's hospital.

Investigators conducted an exploratory study to evaluate the feasibility and potential effects of an innovative, individualized electronic inpatient sexual health intervention (iRAP) for adolescent females. The central hypothesis is that the electronic intervention, based on the Trans Theoretical Model (TTM) of behavior change, will significantly increase adolescent females' requests for STI screening and sexual health management.

Investigators enrolled 70 14-18 year-old, medically stable female inpatients admitted to the hospitalist service at Hasbro Children's Hospital for a randomized control trial during a one-year period. Participants were randomized to receive an electronic sexual risk assessment with or without real-time tailored feedback. Feedback was based on the TTM, utilizing readiness for change to determine appropriate messaging. Participants were then able to electronically request sexual health management options, including STI testing, discussion with their inpatient or outpatient physician, or technology-hosted information on contraception. Investigators conducted a chart review of enrolled adolescents to determine if sexual health topics were addressed.

The investigators are examining participation rates, length of time to perform all study elements, and proportion of teens that obtain requested service. Additionally, the investigators are comparing participants' perceived reproductive health risk and uptake of offered services between the intervention and control groups.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Care Provider, Investigator)

Eligibility Criteria

Ages
14 Years to 18 Years (Child, Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Admitted to the Hospitalist service, English speaking, parent available for consent, medically/psychologically stable.

Exclusion Criteria

  • •Wards of the state, no parent/guardian for consent, non-English speaking

Arms & Interventions

Intervention group

Experimental

Received tailored feedback regarding sexual health risks

Intervention: Tailored feedback (Behavioral)

Control group

No Intervention

Did not receive tailored feedback.

Outcomes

Primary Outcomes

Number of participants with requests for sexual health services, as assessed by sexual health options questionnaire

Time Frame: Immediate

All participants were able to request sexual health services while admitted to the hospital (options included: STI testing, speak with their MD, or watching contraception video). The services were offered using an electronic REDCap questionnaire, with prompt of "Would you like to request X during your hospital stay?" and response options of yes/no. The outcome will be assessed for each sexual health option (number of participants requesting STI testing, discussion with MD, or contraception video viewing) individually, as well as a variable created to show "any uptake" ie. request made for any one or more services.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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