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

10. april 2018 oppdatert av: Rhode Island Hospital
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.

Studieoversikt

Status

Fullført

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

66

Fase

  • Ikke aktuelt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

14 år til 18 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Intervention group
Received tailored feedback regarding sexual health risks
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.
Ingen inngripen: Control group
Did not receive tailored feedback.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of participants with requests for sexual health services, as assessed by sexual health options questionnaire
Tidsramme: 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.
Immediate

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

4. januar 2017

Primær fullføring (Faktiske)

29. oktober 2017

Studiet fullført (Faktiske)

29. oktober 2017

Datoer for studieregistrering

Først innsendt

4. april 2018

Først innsendt som oppfylte QC-kriteriene

10. april 2018

Først lagt ut (Faktiske)

18. april 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. april 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. april 2018

Sist bekreftet

1. mars 2018

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • Oh-Zopfi Pilot Award 2016-2017

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Seksuell atferd

Kliniske studier på Tailored feedback

3
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