- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05618652
Pilottest af en egenkapitalfokuseret og traume-informeret kommunikationsintervention under familiecentrerede runder (EFTI)
Udvikling og pilottest af en egenkapitalfokuseret og traume-informeret kommunikationsintervention under familiecentrerede runder
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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North Carolina
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Durham, North Carolina, Forenede Stater, 27710
- Duke University Health Sustem
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Beskrivelse
Kvalifikationskriterier for pårørende:
- Voksne (18 år eller ældre)
- Behersker engelsk eller spansk
- I stand til at give informeret samtykke
- Identificeret som primær omsorgsperson (forælder eller værge) for et indlagt sort eller latino(a/x) barn på det generelle pædiatriske team.
- Vi vil udelukke omsorgspersoner til børn, der gennemgår evaluering for misbrug/forsømmelse af børn eller andre tilfælde, hvor lægeteamet mener, at familiecentrerede runder ikke er passende.
Berettigelseskriterier for klinikere:
- pædiatrisk behandlende læger, der yder hospitalsbehandling til børn på Duke Children's Hospital.
- I stand til at give informeret samtykke
- Vi vil udelukke klinikere, der ikke yder hospitalsbehandling til børn på det generelle pædiatriske team.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: Kliniker Coaching Øjeblikkelig Intervention Arm-- Caregivers
Klinikere, der modtager interventionen, vil deltage i op til 12 måneder, hvilket inkluderer færdiggørelse af didaktik, 8 lydoptagede kliniske møder, 4 feedbacksessioner og gennemførelse af et kort interview og undersøgelse efter intervention. Efter at have gennemført didaktiske træningselementer vil klinikere modtage coaching og professionel feedback på deres kommunikation med omsorgspersoner til børn på hospitalet. Efterforskerne vil give klinikere illustrative eksempler fra deres møder for at fremskynde diskussion og selvrefleksion. Omsorgspersoner til indlagte børn vil ikke vide, om deres kliniker har modtaget kommunikationsinterventionen. Efterforskerne vil rekruttere 40 plejere i denne arm. |
Klinikerkommunikationsintervention, der inkluderer didaktisk træning og feedback i realtid om kommunikationsadfærd under kliniske møder.
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Andet: Klinikercoaching Ventelistekontrolarm-- Plejegivere
Klinikere i ventelistens kontrolarm vil i første omgang fungere som kontrolarm, og derefter modtage interventionen for at give gennemførligheds- og acceptable data. Klinikere, der er randomiseret til kontrolarmen, vil gennemgå didaktik og feedback, når deres lydoptagelser før indgreb er færdige. Omsorgspersoner for indlagte børn vil ikke vide, om deres kliniker endnu har modtaget kommunikationsinterventionen. Efterforskerne vil rekruttere 40 plejere i denne arm, før klinikere modtager interventionen. |
Klinikerkommunikationsintervention, der inkluderer didaktisk træning og feedback i realtid om kommunikationsadfærd under kliniske møder.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Feasibility Measured by Enrollment Rate of Clinicians and Caregivers
Tidsramme: Up to 12 months
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Up to 12 months
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Feasibility Measured by the Rate of Complete Data Collection by Caregivers
Tidsramme: Up to 12 months
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Up to 12 months
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Fidelity Measured by the Rate of Intervention Elements Completed Per Encounter by Clinicians
Tidsramme: Up to 12 months
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Up to 12 months
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Acceptability of the Intervention as Measured by the Acceptability of Intervention Measure (AIM)
Tidsramme: Up to 12 months following the coaching intervention for each arm
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The AIM has 4 items, each with a response on 5 point Likert scale (1=completely disagree to 5=completely agree).
The score will be averaged for all items for a total score range of 1 to 5, where a higher score indicates great acceptability.
Reported for all hospital clinicians after receiving the intervention (i.e., both clinicians assigned to immediately receive the intervention and the waitlist group).
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Up to 12 months following the coaching intervention for each arm
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Feasibility Measured by the Feasibility of Intervention Measure (FIM)
Tidsramme: Up to 12 months following the coaching intervention for each arm
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The FIM has 4 items, each with a response on 5 point Likert scale (1=completely disagree to 5=completely agree).
The score will be averaged for all items for a total score range of 1 to 5, where a higher score indicates great feasibility.
Reported for all hospital clinicians after receiving the intervention (i.e., both clinicians assigned to immediately receive the intervention and the waitlist group).
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Up to 12 months following the coaching intervention for each arm
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Number of Clinician Rapport-building Statements
Tidsramme: Up to 12 months
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Clinician communication behaviors measured via audio-recorded hospital encounters.
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Up to 12 months
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Number of Clinician Partnership-building Statements
Tidsramme: Up to 12 months
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Clinician communication behaviors measured via audio-recorded hospital encounters.
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Up to 12 months
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Number of Times Team Interrupted the Caregiver
Tidsramme: Up to 12 months
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Clinician communication behaviors measured via audio-recorded hospital encounters.
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Up to 12 months
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Number of Times the Team Praised the Caregiver
Tidsramme: Up to 12 months
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Clinician communication behaviors measured via audio-recorded hospital encounters.
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Up to 12 months
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Number of Times the Team Asked Permission
Tidsramme: Up to 12 months
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Clinician communication behaviors measured via audio-recorded hospital encounters.
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Up to 12 months
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Caregiver Satisfaction Measured by Survey
Tidsramme: Up to 12 months
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Satisfaction was measured with a single item.
Response options: 1=Not at all satisfied, 2= A little satisfied, 3= Satisfied, 4=Extremely Satisfied.
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Up to 12 months
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Caregiver Trust in Their Childs Doctors Measured by the Wake Forest Physician Trust Scale
Tidsramme: Up to 12 months
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Trust was measured using a validated 5-item measure, the Wake Forest Physician Trust Scale.
Responses to each item were a 5-point Likert scale, which was averaged together for these analyses for a total score range of 1 to 5, where a higher score indicates greater trust.
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Up to 12 months
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Caregiver Reported Communication Quality Measured by the Interpersonal Processes of Care Short Form (IPC-18)
Tidsramme: Up to 12 months
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All IPC items use an identical set of response options: 1='never'; 2='rarely'; 3='sometimes'; 4='usually'; 5='always.'
Scale scores are calculated as the mean of non-missing responses to the corresponding items (i.e., item responses are averaged, not summed).
Domains of hurried and discrimination were reverse coded so that higher scores represented better communication.
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Up to 12 months
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Caregiver Reported Communication Quality Measured by the Interpersonal Processes of Care Short Form (IPC-18)
Tidsramme: Up to 12 months
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All IPC items use an identical set of response options: 1='never'; 2='rarely'; 3='sometimes'; 4='usually'; 5='always.'
Scale scores are calculated as the mean of non-missing responses to the corresponding items (i.e., item responses are averaged, not summed).
Lower scores represent better communication.
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Up to 12 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Antal omsorgspersoners deltagelsesadfærd
Tidsramme: Op til 12 måneder
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Efterforskerne vil måle plejepersonalets deltagelse under kliniske møder ved at tælle antallet af gange, plejepersonalet (1) stiller et spørgsmål, (2) angiver en præference og (3) udtrykker en følelse pr. klinikermøde.
Disse tre adfærd vil blive opsummeret og analyseret samlet som en optælling af omsorgspersoners deltagelsesadfærd.
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Op til 12 måneder
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Change in Caregiver Salivary Cortisol
Tidsramme: 30-60 minutes before and 20-30 minutes after FCR
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The investigators will assess for reductions in caregiver salivary cortisol following interactions with clinical teams.
The investigators will collect saliva samples from caregivers at two time points: 30-60 minutes before and 20-30 minutes after family-centered rounds (FCR).
The investigators anticipate lower salivary cortisol levels in the intervention compared to control arm at 20-30 minutes following FCR.
The investigators will also compare differences in the change in cortisol from before and after FCR for each caregiver; the investigators hypothesize caregivers in the intervention arm will have a smaller change from baseline following FCR.
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30-60 minutes before and 20-30 minutes after FCR
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Percentage of Caregivers Who Correctly Identify Child's Diagnosis
Tidsramme: Up to 12 months
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Using validated approach described by Lion et al. the caregiver description of "the main condition child was admitted for" will be compared to the diagnoses listed by the child's doctors in the electronic health record.
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Up to 12 months
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Percentage of Participants With Hospital Readmission at 30 Days
Tidsramme: Up to 30 days after discharge
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Child unplanned hospital readmission
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Up to 30 days after discharge
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of Participants With Hospital Readmission at 90 Days
Tidsramme: Up to 90 days after discharge
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Child unplanned hospital readmission
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Up to 90 days after discharge
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Appropriateness Measured by the Intervention Appropriateness Measure (IAM)
Tidsramme: Up to 12 months following the coaching intervention for each arm
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The IAM has 4 items, each with a response on 5 point Likert scale (1=completely disagree to 5=completely agree).
The score will be averaged for all items for a total score range of 1 to 5, where a higher score indicates great appropriateness.
Reported for all hospital clinicians after receiving the intervention (i.e., both clinicians assigned to immediately receive the intervention and the waitlist group).
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Up to 12 months following the coaching intervention for each arm
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Victoria M. Parente, MD, Duke University
Publikationer og nyttige links
Generelle publikationer
- Parente VM, Khan A, Robles JM. Belonging on Rounds: Translating Research Into Inclusive Practices for Families With Limited English Proficiency to Promote Safety, Equity, and Quality. Hosp Pediatr. 2022 May 1;12(5):e171-e173. doi: 10.1542/hpeds.2022-006581. No abstract available.
- Parente V, Stark A, Key-Solle M, Olsen M, Sanders LL, Bartlett KW, Pollak KI. Caregiver Inclusivity and Empowerment During Family-Centered Rounds. Hosp Pediatr. 2022 Feb 1;12(2):e72-e77. doi: 10.1542/hpeds.2021-006034.
- Khan A, Parente V, Baird JD, Patel SJ, Cray S, Graham DA, Halley M, Johnson T, Knoebel E, Lewis KD, Liss I, Romano EM, Trivedi S, Spector ND, Landrigan CP; Patient and Family Centered I-PASS SCORE Scientific Oversight Committee; Bass EJ, Calaman S, Fegley AE, Knighton AJ, O'Toole JK, Sectish TC, Srivastava R, Starmer AJ, West DC. Association of Patient and Family Reports of Hospital Safety Climate With Language Proficiency in the US. JAMA Pediatr. 2022 Aug 1;176(8):776-786. doi: 10.1001/jamapediatrics.2022.1831.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
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
- Pro00111356
- 1K23MD018433 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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