The Effect of Intensive Inpatient Attending Supervision on Medical Errors, Patient Safety and Resident Education
18. oktober 2017 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
134
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
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
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: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / 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.
|
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.
|
Attendings participated directly in new patient rounds but did not see patients previously known to the team with the residents.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Kathleen Finn, MD, Massachusetts General Hospital
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.
Generelle publikasjoner
- Biondi EA, Varade WS, Garfunkel LC, Lynn JF, Craig MS, Cellini MM, Shone LP, Harris JP, Baldwin CD. Discordance between resident and faculty perceptions of resident autonomy: can self-determination theory help interpret differences and guide strategies for bridging the divide? Acad Med. 2015 Apr;90(4):462-71. doi: 10.1097/ACM.0000000000000522.
- Starmer AJ, O'Toole JK, Rosenbluth G, Calaman S, Balmer D, West DC, Bale JF Jr, Yu CE, Noble EL, Tse LL, Srivastava R, Landrigan CP, Sectish TC, Spector ND; I-PASS Study Education Executive Committee. Development, implementation, and dissemination of the I-PASS handoff curriculum: A multisite educational intervention to improve patient handoffs. Acad Med. 2014 Jun;89(6):876-84. doi: 10.1097/ACM.0000000000000264.
- Finn KM, Metlay JP, Chang Y, Nagarur A, Yang S, Landrigan CP, Iyasere C. Effect of Increased Inpatient Attending Physician Supervision on Medical Errors, Patient Safety, and Resident Education: A Randomized Clinical Trial. JAMA Intern Med. 2018 Jul 1;178(7):952-959. doi: 10.1001/jamainternmed.2018.1244.
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)
1. september 2015
Primær fullføring (Faktiske)
1. juni 2016
Studiet fullført (Faktiske)
1. april 2017
Datoer for studieregistrering
Først innsendt
16. oktober 2017
Først innsendt som oppfylte QC-kriteriene
18. oktober 2017
Først lagt ut (Faktiske)
23. oktober 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
23. oktober 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. oktober 2017
Sist bekreftet
1. oktober 2017
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 2015D005158
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
The data and results from the study are listed to the research personnel associated with the study.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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