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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Behavioral: Co-Localization with Nursing
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 25, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 24, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 13, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 28, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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