Patient SafetyNCT01134419
Implementing a Comprehensive Handoff Program to Improve Pediatric Patient Safety
A study testing Computerized handoff tool and Team training in people with Patient Safety and Resident Workflow, run by Boston Children's Hospital at 1 site in United States.
Trial summary
The investigators propose to test the hypothesis that implementation of a comprehensive handoff program (CHP) - i.e., implementation of a computerized handoff tool along with teamwork training for pediatric residents on inpatient units at Children's Hospital Boston - will lead to reductions in resident… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Patient Safety, Resident Workflow, Resident Experience
- What is being tested?
- Computerized handoff tool and Team training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jan 2010
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- all residents working on study units during study period, except as below
Who cannot join
- residents on the teamwork only unit who have previously been on the primary intervention unit
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
The investigators propose to test the hypothesis that implementation of a comprehensive handoff program (CHP) - i.e., implementation of a computerized handoff tool along with teamwork training for pediatric residents on inpatient units at Children's Hospital Boston - will lead to reductions in resident miscommunications / medical errors and improvements in workflow and experience on the wards.
Read the detailed description
Following collection of baseline data on two inpatient pediatric wards, teamwork training is to be provided to all pediatric residents. On our primary intervention unit, this will be accompanied by the introduction of a new computerized handoff tool that facilitates accurate transmission of data. The effects of this combined intervention on safety and workflow will be assessed on the primary intervention ward as compared with the historical control unit and the concurrent unit that received teamwork training without the computerized tool.
- Conditions
- Patient Safety, Resident Workflow, Resident Experience
- Being tested
- Computerized handoff tool, Team training
- Keywords
- Patient Safety, Medical Errors, Handoff, Sign-out, Resident, Intern, Graduate Medical Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized handoff toolOther
Informatics tool to aid in transfer of patient care information
Team trainingOther
Teamwork training and revisions of handoff structure to optimize teamwork skills and verbal communications
| Study group | Role | What they receive |
|---|---|---|
| Computerized Handoff Tool plus training | Experimental | Computerized handoff tool implemented together with team training for residents Receives: Other: Computerized handoff tool; Other: Team training |
| Team training only | Active comparator | No computerized tool Receives: Other: Team training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of resident-related communication and total medical errors
Resident-related medical errors (including medication-related, diagnostic, and procedural) detected using a multi-pronged prospective surveillance methodology that involves 5d/week chart review, review of hospital incident reports, and collection of staff reports. Resident-related defined as involving a resident research subject. Communication errors are those medical errors attributable to communication failures.
Measured: July 2010
Secondary outcomes (5)
Rates of total medical errors
As above, but includes both those errors involving residents and those involving all other clinical personnel.
Measured: July 2010
Minutes residents spend updating the signout; minutes spent in direct patient care; minutes spent working at computer
Measured: July 2010
Resident reported experience of care
Self-reported, Likert scales on survey instruments.
Measured: July 2010
Rates of verbal miscommunications
Detected by direct observation, audio recording, then rating using study instrument developed for this purpose.
Measured: July 2010
Rates of written miscommunications
Detected by detailed review of written signouts, rated using study instrument developed for this purpose.
Measured: July 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2010 (estimated)
- Study startJul 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SafetyStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard Risk Management Foundation
- Responsible party
- Principal investigator, Christopher Landrigan, Boston Children's Hospital
- Investigators
- Christopher P Landrigan, MD, MPH, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01134419
- Sponsor's protocol ID
- X09-01-0040
- Status last verified
- May 2013
- First submitted
- 25 May 2010
- Last updated
- 16 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing a Comprehensive Handoff Program to Improve Pediatric Patient Safety
- ClinicalTrials.gov ID
- NCT01134419
- Acronym / sponsor ID
- X09-01-0040
- Conditions
- Patient Safety, Resident Workflow, Resident Experience
- Keywords
- Patient Safety, Medical Errors, Handoff, Sign-out, Resident, Intern, Graduate Medical Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Harvard Risk Management Foundation
- Study start
- Jul 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 2 Jun 2010 (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.
The investigators propose to test the hypothesis that implementation of a comprehensive handoff program (CHP) - i.e., implementation of a computerized handoff tool along with teamwork training for pediatric residents on inpatient units at Children's Hospital Boston - will lead to reductions in resident miscommunications / medical errors and improvements in workflow and experience on the wards.
Detailed description
Following collection of baseline data on two inpatient pediatric wards, teamwork training is to be provided to all pediatric residents. On our primary intervention unit, this will be accompanied by the introduction of a new computerized handoff tool that facilitates accurate transmission of data. The effects of this combined intervention on safety and workflow will be assessed on the primary intervention ward as compared with the historical control unit and the concurrent unit that received teamwork training without the computerized tool.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computerized Handoff Tool plus training | Experimental | Other: Computerized handoff tool, Other: Team trainingComputerized handoff tool implemented together with team training for residents |
| Team training only | Active comparator | Other: Team trainingNo computerized tool |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- all residents working on study units during study period, except as below
Key exclusion criteria (1 listed)
- residents on the teamwork only unit who have previously been on the primary intervention unit
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 |
|---|---|---|
| Computerized handoff toolInformatics tool to aid in transfer of patient care information | Other | Computerized Handoff Tool plus training |
| Team trainingTeamwork training and revisions of handoff structure to optimize teamwork skills and verbal communications | Other | Computerized Handoff Tool plus training, Team training only |
Primary outcome
Rates of resident-related communication and total medical errors
Time frame: July 2010
Resident-related medical errors (including medication-related, diagnostic, and procedural) detected using a multi-pronged prospective surveillance methodology that involves 5d/week chart review, review of hospital incident reports, and collection of staff reports. Resident-related defined as involving a resident research subject. Communication errors are those medical errors attributable to communication failures.
5 secondary outcomes
Rates of total medical errors
Time frame: July 2010
Minutes residents spend updating the signout; minutes spent in direct patient care; minutes spent working at computer
Time frame: July 2010
Resident reported experience of care
Time frame: July 2010
Rates of verbal miscommunications
Time frame: July 2010
Rates of written miscommunications
Time frame: July 2010
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 16 May 2013.
Related trials for Patient Safety
RecruitingPhase 3
A Study to Learn About the Effects of the Combination of Elranatamab, Daratumumab and Lenalidomide Compared With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant
Multiple Myeloma
Not yet recruitingPhase 2
Adjuvant Therapeutic Cancer Vaccine (AST-201, pUMVC3-hIGFBP-2) in Patients With Advanced Ovarian Cancer
Advanced Ovarian Cancer
Not yet recruitingPhase 2
Safety and Efficacy of Gemcitabine, Toripalimab and Dose- Modified Lenvatinib in Elderly Patients With Advanced Biliary Tract Cancer Intolerant to Conventional Chemotherapy
Advanced Biliary Tract Cancer
RecruitingPhase 1/2
A Phase I/II Study of ITU512 in Healthy Participants and Patients With Sickle Cell Disease
Sickle Cell Disease
RecruitingPhase 3
A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis
Multiple Sclerosis (MS) Primary Progressive
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.
Christopher P Landrigan, MD, MPH principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized handoff tool and Team training in people with Patient Safety and Resident Workflow, run by Boston Children's Hospital 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 16 May 2013. 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. 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?
Rates of resident-related communication and total medical errors (time frame: July 2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2013.