The Effect of Intensive Inpatient Attending Supervision on Medical Errors, Patient Safety and Resident Education
18 octobre 2017 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
134
Phase
- N'est pas applicable
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: 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.
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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.
|
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Comparateur placebo: 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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Measurement of the rate of medical errors defined as preventable adverse events and near misses. Patient Safety Outcome
Délai: 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
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9 months
|
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Resident Engagement on Rounds: Educational Outcome
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Resident and Faculty Perception of Education, Educational Outcome
Délai: 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
|
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Deaths, Patient Safety Outcome
Délai: 9 months
|
Hospital collected data on the number of medical patients who died during the study
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9 months
|
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Transfers to the Intensive Care Unit, Patient Safety Outcome
Délai: 9 months
|
Hospital collected data on the number of medical patients who were transferred to the intensive care unit
|
9 months
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Kathleen Finn, MD, Massachusetts General Hospital
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 septembre 2015
Achèvement primaire (Réel)
1 juin 2016
Achèvement de l'étude (Réel)
1 avril 2017
Dates d'inscription aux études
Première soumission
16 octobre 2017
Première soumission répondant aux critères de contrôle qualité
18 octobre 2017
Première publication (Réel)
23 octobre 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
23 octobre 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
18 octobre 2017
Dernière vérification
1 octobre 2017
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 2015D005158
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
The data and results from the study are listed to the research personnel associated with the study.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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