Focus of Study is on Graduate Medical Education Supervision Clinical Trial
Official title:
The Effect of Intensive Inpatient Attending Supervision on Medical Errors, Patient Safety and Resident Education
| Verified date | October 2017 |
| Source | Massachusetts General Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Massachusetts General Hospital |
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
| 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 |