Medical ErrorsNCT01130987
Implementing a Comprehensive Handoff Program to Improve Patient Safety
A study testing Computerized handoff tool and Team training in people with Medical Errors, run by Brigham and Women's Hospital at 3 sites 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 internal medicine residents on inpatient units at Walter Reed and Madigan Army Medical Centers - will lead to reductions… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Medical Errors
- What is being tested?
- Computerized handoff tool and Team training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2009to Mar 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 internal medicine residents completing rotations through intervention units during data collection periods
Who cannot join
- none
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Walter Reed Army Medical Center
Bethesda, Maryland, 20307
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Madigan Army Medical Center
Tacoma, Washington, 98431
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 internal medicine residents on inpatient units at Walter Reed and Madigan Army Medical Centers - 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 inpatient wards at both hospitals, teamwork training will be provided, 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 intervention wards at both hospitals as compared with the historical control period.
- Conditions
- Medical Errors
- Being tested
- Computerized handoff tool, Team training
- Keywords
- resident, intern, patient safety, medical error, time motion, handoff, sign-out, Resident Workflow, Resident Communications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized handoff toolOther
Computer program that facilitates accurate transmission of patient information between residents
Team trainingBehavioural
Training in teamwork and reorganization of handoff processes to optimize transmission of information and team care
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive Handoff Program | Experimental | Introduction of Computerized tool plus team training Receives: Other: Computerized handoff tool; Behavioral: Team training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of resident communication and total medical errors
Measured: July 2010
Secondary outcomes (5)
Rates of all medical errors
Measured: July 2010
Rates of verbal miscommunications
Measured: July 2010
Rates of written miscommunications
Measured: July 2010
Resident workflow, especially time spent updating the signout; time spent at bedside; time spent at computer
Measured: July 2010
Resident care experience
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 posted26 May 2010 (estimated)
- Study startJul 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical ErrorsStudies of the same condition, open and under way.
- More trials run by Brigham and Women'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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Walter Reed Army Medical Center, Madigan Army Medical Center
- Responsible party
- Principal investigator, Christopher P. Landrigan, MD, MPH, Brigham and Women's Hospital
- Investigators
- Christopher P Landrigan, MD, MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01130987
- Sponsor's protocol ID
- 2008P002191
- Other IDs
- BAA01 07005001
- Status last verified
- Jun 2014
- First submitted
- 12 Jan 2010
- Last updated
- 18 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing a Comprehensive Handoff Program to Improve Patient Safety
- ClinicalTrials.gov ID
- NCT01130987
- Acronym / sponsor ID
- 2008P002191
- Conditions
- Medical Errors
- Keywords
- resident, intern, patient safety, medical error, time motion, handoff, sign-out, Resident Workflow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- United States Department of Defense, Walter Reed Army Medical Center, Madigan Army Medical Center
- Study start
- Jul 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 26 May 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 internal medicine residents on inpatient units at Walter Reed and Madigan Army Medical Centers - 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 inpatient wards at both hospitals, teamwork training will be provided, 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 intervention wards at both hospitals as compared with the historical control period.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Comprehensive Handoff Program | Experimental | Other: Computerized handoff tool, Behavioral: Team trainingIntroduction of Computerized tool plus team training |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- all internal medicine residents completing rotations through intervention units during data collection periods
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 |
|---|---|---|
| Computerized handoff toolComputer program that facilitates accurate transmission of patient information between residents | Other | Comprehensive Handoff Program |
| Team trainingTraining in teamwork and reorganization of handoff processes to optimize transmission of information and team care | Behavioural | Comprehensive Handoff Program |
Primary outcome
Rates of resident communication and total medical errors
Time frame: July 2010
5 secondary outcomes
Rates of all medical errors
Time frame: July 2010
Rates of verbal miscommunications
Time frame: July 2010
Rates of written miscommunications
Time frame: July 2010
Resident workflow, especially time spent updating the signout; time spent at bedside; time spent at computer
Time frame: July 2010
Resident care experience
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 18 Jun 2014.
Related trials for Medical Errors
Active, not recruiting
Evaluation of the Effect of a Low-FODMAP Diet on Gastrointestinal Symptoms and Inflammatory Markers in Fabry Patients
Fabry Disease
RecruitingObservational study
Establishment of Genomic and Phenotypic Database for Niemann-Pick Disease, Type C
Niemann-Pick Disease, Type C
Not yet recruiting
AI-Based Quality Control for Radiology Reporting
Radiology, Medical Errors
RecruitingObservational study
Abbott Vascular Medical Device Registry
Acute Myocardial Infarction, Restenoses, Coronary
Not yet recruitingObservational study
Specialist Review of Harm Ratings for Clinical Responses Acronym: NOHARM
Patient Safety, Medical Errors
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
Brigham and Women's Hospital
3 sites 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 Medical Errors, run by Brigham and Women's Hospital at 3 sites 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 18 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 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 18 Jun 2014.