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

NCT03318198 | Completed

• 1 other identifier: 2015D005158
• Study Type: interventional
• Target: 134
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Focus of Study is on Graduate Medical Education Supervision

Keywords

Graduate Medical Education; Attending Supervision of Residents; Patient Safety

Outcome Measures

Primary Outcomes (2)

• Measurement of the rate of medical errors defined as preventable adverse events and near misses. Patient Safety Outcome

  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

  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

Secondary Outcomes (3)

• Resident and Faculty Perception of Education, Educational Outcome

  9 months

• Deaths, Patient Safety Outcome

  9 months

• Transfers to the Intensive Care Unit, Patient Safety Outcome

  9 months

Study Arms (2)

Intervention Arm

ACTIVE COMPARATOR

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.

Other: Enhanged Attending Supervision

Control Arm

PLACEBO COMPARATOR

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.

Other: Standard of Care

Interventions

Enhanged Attending Supervision OTHER

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.

Intervention Arm

Standard of Care OTHER

Attendings participated directly in new patient rounds but did not see patients previously known to the team with the residents.

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Related Publications (3)

• 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.

  PMID: 25340363 BACKGROUND

• 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.

  PMID: 24871238 BACKGROUND

• 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.

  PMID: 29868877 DERIVED

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Kathleen Finn, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Inpatient Associate Program Director

Model Details: We 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. Resident education was evaluated via a time motion study to assess resident participation on rounds and surveys to measure resident and attending educational ratings.

Study Record Dates

• First Submitted: October 16, 2017
• First Posted: October 23, 2017
• Study Start: September 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: April 1, 2017
• Last Updated: October 23, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share