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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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
- Educate residents on the content and process of quality handoffs (Medical Knowledge)
- Educate residents on good communication skills (Communication competency)
- Improve perceived continuity of patient care, decrease adverse events related to transfer of care. (Patient safety competency)
- 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 group | Role | What they receive |
|---|---|---|
| Didactic | Experimental | 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 Receives: Behavioral: Didactic |
| Didactic+Simulation | Experimental | 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. Receives: Behavioral: Didactic+Simulation |
| Control | Placebo comparator | 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. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
nightfloat residents' overall judgment on the handoff quality and observed verbal and written handoff performance by interns
Measured: daily, over 3 month study period
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.
- First posted10 Jun 2009 (estimated)
- Study startSep 2007
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Watson, Henry Ford Health System
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Strategies Which Improve the Clinical Handoff (I-SWITCH) Phase II: Randomized Controlled Trial Evaluating Educational Modalities Including Cognitive Simulation
- ClinicalTrials.gov ID
- NCT00917072
- Acronym / sponsor ID
- I-SWITCH / HFH-4694
- Conditions
- Healthy
- Keywords
- Clinical Handoff, Medical Education, Simulation, Residency and Internship
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 10 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Educate residents on the content and process of quality handoffs (Medical Knowledge)
- Educate residents on good communication skills (Communication competency)
- Improve perceived continuity of patient care, decrease adverse events related to transfer of care. (Patient safety competency)
- Increase providers (night residents) satisfaction with the continuity of care during handoffs. (system-based practice/ Practice-based learning)
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Didactic | Experimental | Behavioral: DidacticGroup #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+Simulation | Experimental | Behavioral: Didactic+SimulationGroup #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. |
| Control | Placebo comparator | Behavioral: ControlThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DidacticGroup #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 | Behavioural | Didactic |
| Didactic+SimulationGroup #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 | Behavioural | Didactic+Simulation |
| ControlThe 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. | Behavioural | Control |
Primary outcome
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
2 secondary outcomes
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
interns' knowledge and attitudes on their handoff performance
Time frame: pre-intervention, and 30 days post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Results publicationHan, 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.