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HealthyI-SWITCHNCT00917072

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

A study testing Didactic and Didactic+Simulation in people with Healthy, run by Henry Ford Health System at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Didactic and Didactic+Simulation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
39 participants
Where
1 siteUnited States
Study dates
Sep 2007to Jan 2008
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Henry Ford Hospital

    Detroit, Michigan, 48202

Other trials in United States

About this study

Official title: 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)
Read the 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

Conditions
Healthy
Being tested
Didactic, Didactic+Simulation, Control
Keywords
Clinical Handoff, Medical Education, Simulation, Residency and Internship

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DidacticBehavioural

    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

  • Didactic+SimulationBehavioural

    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

  • ControlBehavioural

    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.

Study groups in NCT00917072
Study groupRoleWhat they receive
DidacticExperimentalGroup #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
Receives: Behavioral: Didactic
Didactic+SimulationExperimentalGroup #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.
Receives: Behavioral: Didactic+Simulation
ControlPlacebo comparatorThe 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.
Receives: Behavioral: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Critical missed events or 'surprises' overnight due to an inadequate or unclear handoff (errors/intern/night), as determined by nightfloat residents

    Measured: daily for 3 month study period

Secondary outcomes (2)
  1. nightfloat residents' overall judgment on the handoff quality and observed verbal and written handoff performance by interns

    Measured: daily, over 3 month study period

  2. interns' knowledge and attitudes on their handoff performance

    Measured: pre-intervention, and 30 days post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2009 (estimated)
  2. Study startSep 2007
  3. Primary completionJan 2008
  4. Study completionJan 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00917072
Sponsor's protocol ID
HFH-4694
Acronym
I-SWITCH
Status last verified
Aug 2023
First submitted
9 Jun 2009
Last updated
4 Aug 2023
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Didactic and Didactic+Simulation in people with Healthy, run by Henry Ford Health System at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00917072, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.

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