Innovative Strategies Which Improve the Clinical Handoff (I-SWITCH) (I-SWITCH)

August 2, 2023 updated by: Peter Watson, Henry Ford Health System

Innovative Strategies Which Improve the Clinical Handoff (I-SWITCH) Phase II: Randomized Controlled Trial Evaluating Educational Modalities Including Cognitive Simulation

Study the feasibility of different educational modalities to improve resident handoff of patient information b) Determine whether different educational modalities (powerpoint vs. simulation workshop) lead to improved educational and (surrogate) clinical outcomes

  1. Educate residents on the content and process of quality handoffs (Medical Knowledge)
  2. Educate residents on good communication skills (Communication competency)
  3. Improve perceived continuity of patient care, decrease adverse events related to transfer of care. (Patient safety competency)
  4. Increase providers (night residents) satisfaction with the continuity of care during handoffs. (system-based practice/ Practice-based learning)

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

Randomize interns into three groups. The control group has been described above. Two more groups will randomized to one of two interventions: Intervention Group #1: will have a focused, interactive power point lecture on the background, content and guidelines for a good handoff (focus on a standardized electronic hand-off tool). They will have an exercise to complete. Intervention Group #2: will undergo the same power point lecture ( as in Group #1) with an additional intervention focused not only on the hand-off tool, but on a standardized hand-off process using an OSCE exercise (objective structured clinical exam). This group will be trained about the effective implementation of the hand-off tool. They will be taught how to standardize the hand-off process and will be given an opportunity to practice with their peers in the HFH simulation center. Up to 12 residents will be taken in pairs to practice written and verbal handoff skills in the simulation center under peer observation and by faculty (investigators, PI). Each intern will be given a simulated patient history and physical and any relevant information related to the patient's hospital course. The intern will be given five minutes to create a handoff. Each pair will go into a separate room that will be recorded and viewed by their peers and instructor. They will be observed giving a handoff and receiving a handoff. When they exit the room, they will provide feedback to one another regarding the quality of the handoff. Then the peers will give additional feedback. Each intern will go through the process of giving a handoff and the one accepting the handoff. After the simulation, they will complete a short survey on the intervention. At the completion of the educational interventions, throughout the year as part of regular intern evaluations, night residents will be asked on a weekly basis to evaluate the efficacy of intern handoffs. In addition, de-identified written handoffs will be evaluated by the investigators and scored for completeness and accuracy. The resident cross covering will be blinded to the intern group. They will evaluate the handoff process. During this process, content omission can be measured, as well as time taken to cross cover a patient.

All interns participating in the study will do a self-assessment of their handoff skills. Interns will then be randomized into one of three groups as described above and undergo the educational intervention (#1 or #2) or standard education (control). Educational interventions will be completed within 10 days of the start of the study (Specific Aims #1,2). Following the interventions interns will be assessed throughout the year using a standardized grading form that evaluates written and verbal handoff skills, and perceived effectiveness of handofffs and it pertains to patient care for interns on inpatient rotations that month (Specific Aim #3,4). This will be completed on a weekly basis by night residents (second and third year residents not involved in the study, and blinded to the intervention groups). Educational endpoints: perceived improvement in handoff skills by interns involved in the study over a 6 month period of time as compared among the intervention groups. (Surrogate) Clinical Endpoints: 1) Objective handoff skills evaluation of interns by more senior residents using a standardized grading form 2) Review of electronic handoff forms by investigators, forms by individual interns will be blinded to the investigators to reduce bias

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.
39

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
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Inclusion: interns starting July 1st 2007 in the internal medicine program and including EM/IM residents starting in July 1st, 2007. All residents will participate as part of an ongoing quality improvement project in the internal medicine curriculum.

Exclusion Criteria:

  • None

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: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

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: Didactic
Group #1: will have a focused, interactive power point lecture on the background, content and guidelines for a good handoff (focus on a standardized electronic hand-off tool). They will have an exercise to complete
Behavioral: Didactic
Group #1: will have a focused, interactive power point lecture on the background, content and guidelines for a good handoff (focus on a standardized electronic hand-off tool). They will have an exercise to complete
Experimental: Didactic+Simulation
Group #2: will undergo the same power point lecture ( as in Group #1) with an additional intervention focused not only on the hand-off tool, but on a standardized hand-off process using an OSCE exercise (objective structured clinical exam). This group will be trained about the effective implementation of the hand-off tool. They will be taught how to standardize the hand-off process and will be given an opportunity to practice with their peers in the HFH simulation center.
Behavioral: Didactic+Simulation
Group #2: will undergo the same power point lecture ( as in Group #1) with an additional intervention focused not only on the hand-off tool, but on a standardized hand-off process using an OSCE exercise (objective structured clinical exam). This group will be trained about the effective implementation of the hand-off tool. They will be taught how to standardize the hand-off process and will be given an opportunity to practice with their peers in the HFH simulation center
Placebo Comparator: Control
The control group received no formal handoff training other than an introduction to handoffs for all interns during orientation at the start of the academic year along with expected ward based experiential training from senior residents throughout the intern year.
Behavioral: Control
The control group received no formal handoff training other than an introduction to handoffs for all interns during orientation at the start of the academic year along with expected ward based experiential training from senior residents throughout the intern year.

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
Time Frame
Critical missed events or 'surprises' overnight due to an inadequate or unclear handoff (errors/intern/night), as determined by nightfloat residents
Time Frame: daily for 3 month study period
daily for 3 month study period

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
Time Frame
nightfloat residents' overall judgment on the handoff quality and observed verbal and written handoff performance by interns
Time Frame: daily, over 3 month study period
daily, over 3 month study period
interns' knowledge and attitudes on their handoff performance
Time Frame: pre-intervention, and 30 days post-intervention
pre-intervention, and 30 days post-intervention

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.
Henry Ford Health System

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

  • Han, Jenny; Lukowski, Anna; Watson, Peter. Innovative Strategies Which Improve the Clinical Handoff (I-SWITCH) Phase II: Randomized Controlled Trial Evaluating Educational Modalities Including Cognitive Simulation. The Journal of Hospital Medicine. 2009;4(s1):26

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

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.
September 1, 2007

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.
January 1, 2008

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.
January 1, 2008

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).
June 9, 2009

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.
June 9, 2009

First Posted (Estimated)

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.
June 10, 2009

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.
August 4, 2023

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.
August 2, 2023

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.
August 1, 2023

More Information

Terms related to this study

Keywords

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.
  • HFH-4694

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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