- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05213117
Optimizing Medical "Teaming" on Resident Based Teams
January 14, 2022 updated by: Kathleen Finn, Massachusetts General Hospital
The main objective of this study is to evaluate the colocalization of internal medicine residents on one clinical inpatient hospital floor for all general medicine block rotations during the 2019-2020 academic year.
Specifically, the aims of the study are to determine if co-localization improves familiarity with nursing staff, which in turn, improves team work, psychological safety, patient care and reduces burnout.
The investigators' hypothesis is that co-localization will increase familiarity between residents and nurses and result in improved psychological safety, team work and patient outcomes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Teamwork is critical in delivering high quality medical care.
Failures in team communication and coordination have been cited as significant contributors to medical errors.
In large teaching hospitals, patients receive care from transiently formed teams of nurses and residents who may only work together for as little as two weeks, as residents rotate through many clinical floors due to the complexity of resident scheduling.
Unlike more established teams that work together over long periods of time, these transient groups are called "teaming;" a process where a group of diverse providers, with different roles, outlooks and levels of professional training transiently come together to carry out complex tasks.
(Reference: Dr. Amy Edmondson, Harvard Business School) A key risk in "teaming" is the lack of familiarity of team members as studies suggest familiarity promotes an environment of psychological safety, where team members feel safe speaking up, asking for help and admitting errors.
These skills are important for both team work and patient safety.
The investigators hypothesize that in large residency programs where resident rotate on multiple floors, it is possible to improve the quality of "teaming" by increasing the frequency with which smaller groups of residents and nurses work together.
As a result, the investigators propose a randomized controlled trial on an inpatient general medical floor to study the effect of co-localizing residents with nursing staff.
One cohort of residents will be assigned to complete all general medical rotations on a single floor for the academic year.
The investigators will assess the impact on psychological safety, team work and patient care.
The investigators hypothesize by co-localizing residents with nursing, while these "teaming" are still transient, the slight increase in familiarity will promote a culture of psychological safety and improve team work.
If benefits are found, resident scheduling can be adjusted in subsequent years.
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
24 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All incoming PGY-1 residents who volunteer to be randomized
Exclusion Criteria:
- Any incoming PGY-1 resident who declines to be randomized
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Co-localized Residents
Investigators plan to randomize 15 PGY-1 residents in internal medicine from the possible 74 PGY-1 incoming residents who agree to partake in the study, to one general medicine clinical floor for the academic year.
These co-localized residents will complete 16-20 weeks of scheduled rotation time on White 9
|
Co-localize 15 residents to one of 6 general medical floors to complete all 8 weeks of general medicine on this floor
|
|
No Intervention: Normally Schedule Residents
The control arm will consist of 18 PGY-1 residents who are scheduled by the residency program's algorithm in the usual fashion to complete general medicine rotations on 5 difference clinical floors.
The 18 active comparator participants will be selected based on completing one of four general medicine rotation on the control floor White 8.
These participants will then be followed while completing the remaining general medicine rotations on all clinical floors.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Teamwork assessed by Simulation about Shortness of Breath
Time Frame: This simulation will be conducted at 6 months in this 12month study
|
Simulation of an inpatient clinical scenario will be conducted.
This simulation about shortness of breath will be run with teams consisting of two residents and two nurses.
These interdisciplinary teams will be asked to manage a patient together.
All residents and nurses in the study will be asked to participate in the simulation.
The simulations will be recorded.
Blinded reviewers will view these simulations later and will score the team's performance using an published Oxford NOTECH simulation teamwork assessment tool.
The assessment tool is designed to identify higher functioning teams by evaluating leadership, communication, shared mental models and utilization of resources.
|
This simulation will be conducted at 6 months in this 12month study
|
|
Teamwork assessed by Simulation about Negotiation with Angry Patient
Time Frame: This simulation will be conducted at 12 months in this 12month study
|
Simulation of an inpatient clinical scenario will be conducted.
This simulation about negotiating with an angry patient will be run with teams consisting of two residents and two nurses.
These interdisciplinary teams will be asked to manage a patient together.
All residents and nurses in the study will be asked to participate in the simulation.
The simulations will be recorded.
Blinded reviewers will view these simulations later and will score the team's performance using an published Oxford NOTECH simulation teamwork assessment tool.
The assessment tool is designed to identify higher functioning teams by evaluating leadership, communication, shared mental models and utilization of resources.
|
This simulation will be conducted at 12 months in this 12month study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychological Safety
Time Frame: Residents and Nurses will be surveyed at 6 months in this 12 month study
|
A survey tool has been developed for both residents and nurses.
The survey tool asks questions using a 5 point Likert scale about psychological safety, communication and teamwork.
The questions were modified based on prior published work by Dr. Amy Edmondson at the Harvard Business School.
The survey will be used to evaluate the residents and nurses perception of teamwork and psychological safety.
|
Residents and Nurses will be surveyed at 6 months in this 12 month study
|
|
Psychological Safety
Time Frame: Residents and Nurses will be surveyed at 12 months in this 12 month study
|
A survey tool has been developed for both residents and nurses.
The survey tool asks questions using a 5 point Likert scale about psychological safety, communication and teamwork.
The questions were modified based on prior published work by Dr. Amy Edmondson at the Harvard Business School.
The survey will be used to evaluate the residents and nurses perception of teamwork and psychological safety.
|
Residents and Nurses will be surveyed at 12 months in this 12 month study
|
|
Communication between Nurses and Interns
Time Frame: Observation will start at 6 months in this 12 month study and continue through study completion, an average of 6 months
|
A time motion study will be conducted where an observer with an Apple iPad will observe rounds with nurses and interns.
The observer will record the amount of time each individual is speaking, the length of rounds and the number of patients rounded on.
|
Observation will start at 6 months in this 12 month study and continue through study completion, an average of 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kathleen F Finn, MD, Massachusetts General Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 25, 2019
Primary Completion (Actual)
June 24, 2020
Study Completion (Actual)
December 13, 2021
Study Registration Dates
First Submitted
December 13, 2021
First Submitted That Met QC Criteria
January 14, 2022
First Posted (Actual)
January 28, 2022
Study Record Updates
Last Update Posted (Actual)
January 28, 2022
Last Update Submitted That Met QC Criteria
January 14, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- Protocol #: 2019P000534
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Study protocol and results
IPD Sharing Time Frame
Data will be published in 2022
IPD Sharing Access Criteria
Plan to publish in 2022
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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