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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03318198
Other study ID # 2015D005158
Secondary ID
Status Completed
Phase N/A
First received October 16, 2017
Last updated October 18, 2017
Start date September 2015
Est. completion date April 2017

Study information

Verified date October 2017
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 134
Est. completion date April 2017
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms

  • Focus of Study is on Graduate Medical Education Supervision

Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Resident and Faculty Perception of Education, Educational Outcome 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
Secondary Deaths, Patient Safety Outcome Hospital collected data on the number of medical patients who died during the study 9 months
Secondary Transfers to the Intensive Care Unit, Patient Safety Outcome Hospital collected data on the number of medical patients who were transferred to the intensive care unit 9 months