Evaluation of an Inpatient Sexual Risk Behavior Assessment Program (iRAP)

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.

Study Overview

• Status: Completed
• Conditions: Sexual Behavior; Adolescent Behavior
• Intervention / Treatment: Behavioral: Tailored feedback

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 Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Received tailored feedback regarding sexual health risks	Behavioral: Tailored feedback; Electronic feedback based on participants "stage of change" which provided risk reduction behavior regarding their sexual health including use of condoms, contraceptions, and STI testing.
No Intervention: Control group; Did not receive tailored feedback.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with requests for sexual health services, as assessed by sexual health options questionnaire	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.	Immediate

Collaborators and Investigators

• Sponsor: Rhode Island Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2017
• Primary Completion (Actual): October 29, 2017
• Study Completion (Actual): October 29, 2017

Study Registration Dates

• First Submitted: April 4, 2018
• First Submitted That Met QC Criteria: April 10, 2018
• First Posted (Actual): April 18, 2018

Study Record Updates

• Last Update Posted (Actual): April 18, 2018
• Last Update Submitted That Met QC Criteria: April 10, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: Oh-Zopfi Pilot Award 2016-2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No