HealthyPhase 3NCT00146354
The Effects of a Results Management System on Physician Awareness of Post-Discharge Test Results
A Phase 3 study testing Hospitalists Results Manager in people with Healthy and Medical Record Systems, Computerized, run by Brigham and Women's Hospital at 2 sites in United States.
Trial summary
This project aims to define the problem of results that return after patient discharge and to study the implementation of an Electronic Medical Record (EMR)-based system for tracking these results. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Medical Record Systems, Computerized
- What is being tested?
- Hospitalists Results Manager
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Admitted under enrolled study Attendings at the two study locations
- Patient had test result finalized after discharge and prior to subsequent admission
Who cannot join
- Test result noted in discharge summary
- Test result not clinically actionable
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02120
About this study
Official title: The Effects of a Results Management System on Physician Awareness of Post-Discharge Laboratory and Radiology Results
This project aims to define the problem of results that return after patient discharge and to study the implementation of an Electronic Medical Record (EMR)-based system for tracking these results.
Read the detailed description
The transfer of care at hospital discharge is complex and requires the transmission of large amounts of data between inpatient physicians (hospitalists) and outpatient physicians (PCPs), including information about pending tests. Frequently, laboratory and radiology tests are not finalized until after a patient is discharged, and when the responsibility for these pending results is not clearly defined, they can be missed. Our project aims to define the problem of these post-discharge results and to study the implementation of an EMR-based system (Hospitalist Results Manager, HRM) for tracking these results on the hospitalist services at Brigham and Women's Hospital (BWH) and Massachusetts General Hospital (MGH). The project consists of two phases: a cross-sectional study before intervention to define the epidemiology of post-discharge results, and a randomized trial of HRM to determine its effect on physician awareness of these results.
- Conditions
- Healthy, Medical Record Systems, Computerized
- Being tested
- Hospitalists Results Manager
- Keywords
- Electronic Medical Record, Electronic Results Tracking, Patient Safety, Post-Discharge Test Results
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hospitalists Results ManagerBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 3
- Primary purpose
- Early clinical test
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard Risk Management Foundation
- Investigators
- Tejal K Gandhi, MD, MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00146354
- Sponsor's protocol ID
- 2003P000551
- Status last verified
- Aug 2005
- First submitted
- 2 Sep 2005
- Last updated
- 2 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Results Management System on Physician Awareness of Post-Discharge Laboratory and Radiology Results
- ClinicalTrials.gov ID
- NCT00146354
- Acronym / sponsor ID
- 2003P000551
- Conditions
- Healthy, Medical Record Systems, Computerized
- Keywords
- Electronic Medical Record, Electronic Results Tracking, Patient Safety, Post-Discharge Test Results
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Harvard Risk Management Foundation
- First posted
- 7 Sep 2005 (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.
This project aims to define the problem of results that return after patient discharge and to study the implementation of an Electronic Medical Record (EMR)-based system for tracking these results.
Detailed description
The transfer of care at hospital discharge is complex and requires the transmission of large amounts of data between inpatient physicians (hospitalists) and outpatient physicians (PCPs), including information about pending tests. Frequently, laboratory and radiology tests are not finalized until after a patient is discharged, and when the responsibility for these pending results is not clearly defined, they can be missed. Our project aims to define the problem of these post-discharge results and to study the implementation of an EMR-based system (Hospitalist Results Manager, HRM) for tracking these results on the hospitalist services at Brigham and Women's Hospital (BWH) and Massachusetts General Hospital (MGH). The project consists of two phases: a cross-sectional study before intervention to define the epidemiology of post-discharge results, and a randomized trial of HRM to determine its effect on physician awareness of these results.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Admitted under enrolled study Attendings at the two study locations
- Patient had test result finalized after discharge and prior to subsequent admission
Key exclusion criteria (2 listed)
- Test result noted in discharge summary
- Test result not clinically actionable
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 |
|---|---|---|
| Hospitalists Results Manager | Behavioural | – |
Primary outcome
Not reported in the source record.
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 2 Mar 2007.
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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.
Tejal K Gandhi, MD, MPH principal investigator
Brigham and Women's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hospitalists Results Manager in people with Healthy and Medical Record Systems, Computerized, run by Brigham and Women's Hospital at 2 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 2 inclusion and 2 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 2 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
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 2 Mar 2007.