- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02607852
Feedback System of PROMS in Children With Burns
System for Feedback of Patient Reported Outcomes in Children With Burns
Studieoversigt
Detaljeret beskrivelse
The primary objective of this pilot study is to ascertain the feasibility and usefulness of a feedback system that provides clinicians with parent-proxy reported outcomes measure data during routine outpatient encounters for burn treatment.
The secondary objective of this first phase of the study is to determine clinicians' and parents perception of the experience of completing the BOQ+P and/or the usefulness of the information that was provided to the clinician and parent/guardians(s). For this reason we will collect a brief debriefing questionnaire from physicians and another from parents.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02114
- Shriners Hospitals for Children- Boston
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Children between the ages of 0 and 18 years of age, receiving outpatient burn care at Shriners Hospitals for Children - Boston with total body surface area burn of ≥ 5% and/or a burn injury to face, hands, feet or genitalia. English or Spanish speaking and literate
Exclusion Criteria:
- Clinician overriding a patient to serve on the study because of medical/psychiatric problems that might in the opinion of the clinician overwhelm the goals/purposes of the study.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Screening
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Andet: Arm A
Patients between the ages of 5-18 years.
They will complete the 5-18 version of the BOQ on iPads or through the HTTPS Tonic link.
|
The current study will help determine if using Burn Outcomes Questionnaire and 17- item Pediatric Symptom Checklist (PSC-17) feedback data, collected on iPads or online, over the course of patient treatment will be useful for the physicians and ultimately impact the recovery of the patient.
|
Andet: Arm B
Patients between the ages of 0-4 years.
They will complete the 0-4 version of the BOQ and appropriate Pediatric Symptom Checklists (i.e.
baby or preschool) on iPads or through the HTTPS Tonic link.
|
The current study will help determine if using Burn Outcomes Questionnaire and 17- item Pediatric Symptom Checklist (PSC-17) feedback data, collected on iPads or online, over the course of patient treatment will be useful for the physicians and ultimately impact the recovery of the patient.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Responses to Clinician Debriefing Questionnaires
Tidsramme: Participants will participate for the duration of one outpatient visit, an expected average of 3 hours.
|
After viewing the BOQ feedback and seeing the patient, the clinicians will rate whether or not they found the BOQ+P data useful.
The measure includes 5 Likert-Scale questions and 1 open-ended question that asks for their feedback about the system.
|
Participants will participate for the duration of one outpatient visit, an expected average of 3 hours.
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Robert L Sheridan, MD, Shriners Hospitals for Children
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BOS1501
- 20170611 (Anden identifikator: Western Institutional Review Board)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Forbrændinger
-
Central Arkansas Veterans Healthcare SystemUnited States Department of Defense; University of ArkansasRekrutteringÅbn Burn Pit ExposureForenede Stater
-
Cairo UniversityRekruttering
-
Cairo UniversityAfsluttet
-
Nepal Health Research CouncilFogarty International Center of the National Institute of HealthRekruttering
-
University of WashingtonFogarty International Center of the National Institute of HealthAfsluttet
-
Arrowhead Regional Medical CenterAfsluttetForbrændinger | Mangel på ascorbinsyre | Væske og elektrolyt ubalance | Forbrændingsgrad anden | Forbrændingsgrad tredje | Burn ShockForenede Stater
Kliniske forsøg med iPads
-
Mayo ClinicAfsluttet
-
Ottawa Hospital Research InstituteAfsluttet
-
Yale UniversityHandhold AdaptiveAfsluttetKommunikationsforstyrrelser | AutismeForenede Stater
-
University of UtahBaylor College of Medicine; National Institute of Nursing Research (NINR); University of Florida og andre samarbejdspartnereAfsluttetParkinsons sygdomForenede Stater
-
Columbia UniversityAfsluttetSmerte, Procedurel | Venepunktur | Nød, ProceduralForenede Stater
-
University Hospital Southampton NHS Foundation...University of SouthamptonAfsluttetSynsfeltdefekt, periferDet Forenede Kongerige
-
Jaeb Center for Health ResearchNational Eye Institute (NEI); Pediatric Eye Disease Investigator GroupAfsluttet
-
University of MichiganMcKesson FoundationAfsluttetEndetarmskræft | TyktarmskræftForenede Stater
-
University of California, San FranciscoTilburg UniversityAfsluttet
-
Yale UniversityHandhold AdaptiveAfsluttetAutismespektrumforstyrrelserForenede Stater