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The Effect of Intensive Inpatient Attending Supervision on Medical Errors, Patient Safety and Resident Education

18. oktober 2017 opdateret af: Kathleen Finn, Massachusetts General Hospital
Randomized cross over trial investigating the effect of intensive attending supervision of residents caring for inpatients on the medical service on both patient safety and educational outcomes. Hypothesis: increased attending supervision would improve patient safety and resident education.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Background While the relationship between resident work hours and patient safety has been extensively studied, little research has evaluated the role of attending supervision on patient safety and education.

Investigators conducted a 9-month randomized, cross-over trial on an inpatient medicine teaching service where 22 faculty provided either: 1) direct supervision where attendings joined work rounds on established (previously admitted) patients or 2) standard supervision where attendings were available, but did not join work rounds. Each faculty member participated in both arms in random order. The primary safety outcome was rate of medical errors. Secondary safety outcomes included deaths and transfers to the intensive care unit. Resident education was evaluated via a time motion study to assess resident participation on rounds and surveys to measure resident and attending educational ratings.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

134

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria

  • Teaching attending on the medicine service at Massachusetts General Hospital
  • Resident physician on the medical service at Massachusetts General Hospital

Exclusion Criteria

  • Faculty unable to complete both control and intervention arms of the study.
  • Faculty unwilling to participate
  • Residents unwilling to participate

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Intervention Arm
Attendings on the interventional arm attended daily work rounds with the resident teams in addition to established work rounds on the previously admitted patients on the care team.
Andet: Enhanged Attending Supervision
Attendings were randomized at the start of the study to begin in the enhanced supervision arm where they attended resident work rounds. They then crossed over to the control arm where they did not attend work rounds. The outcomes were assessed between the two periods during which the attending participated in the study; attending work rounds vs. not attending work rounds.
Placebo komparator: Control Arm
Attendings crossed over to the control arm in which they did not attend work rounds with the team and only say new admissions with the resident team. This was usual care.
Andet: Standard of Care
Attendings participated directly in new patient rounds but did not see patients previously known to the team with the residents.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Measurement of the rate of medical errors defined as preventable adverse events and near misses. Patient Safety Outcome
Tidsramme: 9 months
Using a previously validated protocol (PMID:24871238) to assess these outcomes, five research nurses reviewed the medical records, formal incident reports from the hospital incident-reporting system, daily pharmacy reports, pharmacy paging logs and solicited reports from nurses working on the study units and noted any adverse events or near misses. Four physician investigators, blinded to attending and intervention, classified each suspected incident as an adverse event, near miss or exclusion (an incident determined to be neither a medical error or adverse event). Physician reviewers further classified all adverse events as preventable or non-preventable. Medical Error rates are reports as number of events per 1,000 patient days
9 months
Resident Engagement on Rounds: Educational Outcome
Tidsramme: 9 months
Time motion study of the amount of time residents and faculty speak during rounds. Time was measured by a research assistant using a Microsoft access program embedded on an IPAD that recorded length of time. Time measurement outcomes are reported in minutes
9 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Resident and Faculty Perception of Education, Educational Outcome
Tidsramme: 9 months
A 20 question survey based on prior literature (PMID: 25340363) asking about resident and faculty experience with different levels of faculty supervision. The survey questions each were followed by a 5 point scale with a range from strongly agree, agree, neutral, disagree to strongly disagree. Strongly agree represents a better outcome. There were no subscales.
9 months
Deaths, Patient Safety Outcome
Tidsramme: 9 months
Hospital collected data on the number of medical patients who died during the study
9 months
Transfers to the Intensive Care Unit, Patient Safety Outcome
Tidsramme: 9 months
Hospital collected data on the number of medical patients who were transferred to the intensive care unit
9 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Massachusetts General Hospital

Efterforskere

  • Ledende efterforsker: Kathleen Finn, MD, Massachusetts General Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. september 2015

Primær færdiggørelse (Faktiske)

1. juni 2016

Studieafslutning (Faktiske)

1. april 2017

Datoer for studieregistrering

Først indsendt

16. oktober 2017

Først indsendt, der opfyldte QC-kriterier

18. oktober 2017

Først opslået (Faktiske)

23. oktober 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. oktober 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. oktober 2017

Sidst verificeret

1. oktober 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 2015D005158

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

The data and results from the study are listed to the research personnel associated with the study.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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 .

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