The Effect of Intensive Inpatient Attending Supervision on Medical Errors, Patient Safety and Resident Education
18 oktober 2017 uppdaterad 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.
Studieöversikt
Status
Avslutad
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
134
Fas
- Inte tillämpbar
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / 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.
|
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-jämförare: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Measurement of the rate of medical errors defined as preventable adverse events and near misses. Patient Safety Outcome
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Resident and Faculty Perception of Education, Educational Outcome
Tidsram: 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
Tidsram: 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
Tidsram: 9 months
|
Hospital collected data on the number of medical patients who were transferred to the intensive care unit
|
9 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Kathleen Finn, MD, Massachusetts General Hospital
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 september 2015
Primärt slutförande (Faktisk)
1 juni 2016
Avslutad studie (Faktisk)
1 april 2017
Studieregistreringsdatum
Först inskickad
16 oktober 2017
Först inskickad som uppfyllde QC-kriterierna
18 oktober 2017
Första postat (Faktisk)
23 oktober 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
23 oktober 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
18 oktober 2017
Senast verifierad
1 oktober 2017
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 2015D005158
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
The data and results from the study are listed to the research personnel associated with the study.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Enhanged Attending Supervision
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Botec Analysis, LLCPennsylvania Department of Corrections; Bureau of Justice AssistanceOkänd