- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03152045
Teaching Improved Communication To Adolescents and Clinicians (TicTac)
7. desember 2018 oppdatert av: Duke University
The purpose of this pilot study is to evaluate the feasibility, acceptability, and preliminary efficacy of an intervention aimed at improving how adolescent patients and their clinicians communicate about behavior change.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
The investigators propose a randomized pilot trial across two health systems, Duke University and University of Michigan to evaluate the effect of Feedback Guides on clinician-adolescent communication about high-risk behaviors.
- The investigators consent clinicians prior to any patient recruitment.
- When a patient aged 12-21 years arrives for an annual visit and is a patient of a consented clinician, the front desk staff will provide the teen with an iPad tablet.
- As part of standard clinical care, all teens will complete the Rapid Assessment for Adolescent Preventive Services (RAAPS) questionnaire on the tablet privately (either in waiting room or in clinic room while waiting for the provider).
- The patient and parent will then review a study explanation and informed consent on the tablet and sign electronically if they agree to participate. The study clinician will review the informed consent with the patient and answer any questions.
- Participating teens will then complete a brief baseline survey and those randomized to the intervention arm will print the visit conversation guides using a wireless study printer connected to the tablet. The guides will print in a designated nursing area and clinic staff will add the printed guides to visit-related paperwork for the patient and clinician to use during the visit.
- The teen patient audio records the encounter on the tablet.
- The patient completes post-visit patient survey on tablet.
- The clinician completes a post-visit survey on paper.
- The patient returns tablet to clinic staff.
- The iPad will be connected to a study workstation, where the iTunes application will be used to transfer the audio file from the Voice Memos app to the workstation and then to it's final destination on the file server. Once the transfer has been confirmed, using iTunes, the audio file will be deleted from both the iPad and the workstation, including any residual versions of the audio file.
- Three months after the encounter, staff will provide participating patients a link to a REDCap survey (not the survey itself). The link will be sent using the preferred method selected by the patient through a question in the baseline survey - email or short message service (SMS). To protect the confidentiality of the responses, we will also provide the participant a code to access the REDCap follow-up survey. This will prevent others from accessing the survey results.
Studietype
Intervensjonell
Registrering (Faktiske)
36
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
North Carolina
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Durham, North Carolina, Forente stater, 27705
- Duke University Medical Center
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Durham, North Carolina, Forente stater, 27710
- Duke University Medical Center - Cancer Prevention, Detection and Control
-
-
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
12 år til 21 år (Barn, Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- All English-speaking adolescent patients
- cognitively able to participate
Exclusion Criteria:
- Adolescents less than 12 years of age
- Adolescents over 21 years of age
- cognitively unable to participate.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Communication Intervention
Investigators are testing the feasibility, acceptability, and preliminary efficacy of a systems intervention that asks adolescents to report their risk behaviors before their encounter.
Both clinicians and patients will receive a Feedback Guide that gives them tips on effective ways to communicate about these behaviors.
|
In this study, Investigators are testing the feasibility, acceptability, and preliminary efficacy of a systems intervention that asks adolescents to report their risk behaviors before their encounter.
Both clinicians and patients will receive a Feedback Guide that gives them tips on effective ways to communicate about these behaviors.
|
|
Ingen inngripen: Standard Of Care
Investigators will compare patients randomized into the intervention group to those who receive standard of care.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Feasibility as measured by recruitment number
Tidsramme: 9 months
|
We will consider the intervention feasible if we recruit 20 adolescent patients and up to 10 clinicians per site.
|
9 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Acceptability
Tidsramme: 9 months
|
To determine acceptability, we will examine patients' reports of rated helpfulness of the intervention.
To be deemed acceptable, 75% would have to rate it as a "4" or "5" on the 5-point scale
|
9 months
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Patient perceived provider empathy as measure by a summed 10-question scale
Tidsramme: 10 minutes
|
We will assess patient perceived provider empathy with a summed 10-question scale (α=0.95;
e.g., "Thinking about your visit with your doctor, how was your doctor at fully understanding your concerns?"
(1= Not at all good and 5= Extremely good)).
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10 minutes
|
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Patient perceived autonomy support using a 15 question scale
Tidsramme: 10 minutes
|
We will assess patient autonomy support using a 15 question scale (a=0.95;e.g., "I feel that my physician has provided me choices and potions" (1=Strongly disagree and 5=Strongly agree).
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10 minutes
|
|
Patient's self rated participation in the encounter
Tidsramme: 10 minutes
|
We will assess patient's self rated participation in the encounter using a five-point Likert-type scale (i.e., 1 "Not at all good" - 5 "Extremely good")
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10 minutes
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
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)
25. september 2017
Primær fullføring (Faktiske)
29. oktober 2018
Studiet fullført (Faktiske)
29. oktober 2018
Datoer for studieregistrering
Først innsendt
2. mai 2017
Først innsendt som oppfylte QC-kriteriene
11. mai 2017
Først lagt ut (Faktiske)
12. mai 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. desember 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. desember 2018
Sist bekreftet
1. oktober 2018
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- Pro00078439
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
De-identified web-based surveys from the University of Michigan will be available to Duke researchers through REDCap.
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. .
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