Test Result ManagementNCT01153451
An Automatic Notification System for Test Results Finalized After Discharge
A study testing Email Notification in people with Test Result Management, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Specific Aims: (Study #1, funded by AHRQ, completed May 2011) 1. To create an automatic notification system to prompt physicians of test results finalized after discharge. 2. To evaluate the impact of this system on physician awareness of test results finalized after discharge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Test Result Management
- What is being tested?
- Email Notification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 441 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Jul 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient discharged from selected services at BWH whose inpatient attending and primary care provider are in the same arm of the study.
Who cannot join
- Any patient discharged from selected services at BWH whose inpatient attending and primary care provider are in discordant arms of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Specific Aims: (Study #1, funded by AHRQ, completed May 2011)
- To create an automatic notification system to prompt physicians of test results finalized after discharge.
- To evaluate the impact of this system on physician awareness of test results finalized after discharge.
Read more
Hypothesis: Automatic email notification will improve physician awareness of test results finalized after discharge compared to usual care.
Specific Aims: (Study #2, funded by CRICO, completed July 2012)
- To identify a cohort of discharged patients with potentially actionable results of tests pending at discharge (TPAD).
- To determine if automated email notification of the finalized results of potentially actionable TPADs affects the rate of post-discharge actions taken as documented in the electronic medical record (EMR).
Hypothesis: Automated email notification of the finalized results of potentially actionable TPADs increases the rate of actions taken post-discharge.
Read the detailed description
Failure to follow up on abnormal test results is a critical problem and is more likely to occur in the case of tests that are performed in the hospital but whose results are not available or not finalized until after discharge (i.e., pending test results). Responsible inpatient and ambulatory providers may not be aware of these test results. In a prior study, Roy et al. determined that 41% of patients were discharged before all laboratory, microbiology, and radiology test results were finalized (31% were collectively hematology, chemistry, and pathology tests, 27% were radiology studies, and 42% were microbiology results). Of these results, 9.4% were considered potentially actionable by independent physician review and could have altered the post-discharge patient care plan. Physicians were only aware of 38% of these test results. Failure to follow-up on these test results can lead to delays in diagnosis, missed treatment opportunities, redundant ordering of tests, and subsequent patient harm. In a hospital the size of Brigham and Women's Hospital (BWH) with 44,000 annual admissions, physicians would be unaware of almost 2000 actionable test results per year. Automated systems can mitigate this problem by ensuring prompt notification of relevant test results finalized after discharge to responsible inpatient and ambulatory providers. Using internal BWH funding, we have developed an automated email notification system to facilitate management of tests pending at discharge (TPADs).
In study 1 (funded by AHRQ), we will prospectively evaluate the impact of this intervention on physician awareness of TPAD results. In study 2 (funded by CRICO), we will perform a chart review to determine the impact of the intervention on downstream actions taken by physicians and acknowledgment of TPAD results as documented in the electronic medical record.
- Conditions
- Test Result Management
- Being tested
- Email Notification
- Keywords
- Pending tests, Discharge, Awareness, Care transitions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Email NotificationOther
BWH inpatient clinical information systems will automatically file all non-finalized chemistry, hematology, pathology, and radiology tests, as well as inpatient and ambulatory provider email addresses for all study patients discharged. This process will be initiated using a time stamp most proximate to actual discharge time. At midnight on every day, all tests filed at time of discharge will be updated if final results have become available. An email with all finalized and pending test results for each patient discharged will be sent to the inpatient and primary care provider at this time. For patients discharged with more than one pending test, subsequent email notification(s) will be sent out until all pending tests are finalized (no more than one email per day).
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Responsible inpatient and ambulatory physicians assigned to usual care will not receive any email(s) of patients' test results generated from the notification system. |
| Email Notification | Other | Responsible inpatient and ambulatory physicians will receive automated email(s) of patients' tests results finalized post-discharge generated from the notification system. Finalized results will be batched such that no provider will receive more than one email per day. Receives: Other: Email Notification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Inpatient Providers Aware of Finalized Results of Tests Pending at Discharge (Study 1)
The primary outcome will be the percentage of inpatient physicians who are aware of the finalized results of tests pending at discharge.
Measured: 72 hours after notification, October 2010 thru May 2011
Secondary outcomes (3)
Percent of Ambulatory Providers Aware of Finalized Results of Tests Pending at Discharge (Study 1)
Secondary outcomes will include the percentage of ambulatory physicians who are aware of the finalized results of tests pending at discharge (both Partners network and non-network providers).
Measured: 72 hours after notification, October 2010 thru May 2011
Percent of Providers Aware of Actionable Test Results (Study 1)
Percent awareness of actionable test results by responsible providers
Measured: 72 hours after notification, October 2010 thru May 2011
Provider Satisfaction (Study 1)
Percentage of providers satisfied with the notification system.
Measured: 72 hours after notification, October 2010 thru May 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2010 (estimated)
- Study startOct 2010
- Primary completionMay 2011
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Test Result ManagementStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 441 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anuj K. Dalal, MD, Brigham and Women's Hospital
- Investigators
- Anuj K Dalal, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01153451
- Sponsor's protocol ID
- 1R21HS018229-01
- Other IDs
- CRICO
- Status last verified
- Jun 2013
- First submitted
- 3 Jun 2010
- Last updated
- 5 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Dalal AK, Schaffer A, Gershanik EF, Papanna R, Eibensteiner K, Nolido NV, Yoon CS, Williams D, Lipsitz SR, Roy CL, Schnipper JL. The Impact of Automated Notification on Follow-up of Actionable Tests Pending at Discharge: a Cluster-Randomized Controlled Trial. J Gen Intern Med. 2018 Jul;33(7):1043-1051. doi: 10.1007/s11606-018-4393-y. Epub 2018 Mar 12.
PubMed 29532297Dalal AK, Roy CL, Poon EG, Williams DH, Nolido N, Yoon C, Budris J, Gandhi T, Bates DW, Schnipper JL. Impact of an automated email notification system for results of tests pending at discharge: a cluster-randomized controlled trial. J Am Med Inform Assoc. 2014 May-Jun;21(3):473-80. doi: 10.1136/amiajnl-2013-002030. Epub 2013 Oct 23.
PubMed 24154834
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Automatic Notification System for Test Results Finalized After Discharge
- ClinicalTrials.gov ID
- NCT01153451
- Acronym / sponsor ID
- 1R21HS018229-01
- Conditions
- Test Result Management
- Keywords
- Pending tests, Discharge, Awareness, Care transitions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 441 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- May 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 30 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.
Specific Aims: (Study #1, funded by AHRQ, completed May 2011)
- To create an automatic notification system to prompt physicians of test results finalized after discharge.
- To evaluate the impact of this system on physician awareness of test results finalized after discharge.
Hypothesis: Automatic email notification will improve physician awareness of test results finalized after discharge compared to usual care.
Specific Aims: (Study #2, funded by CRICO, completed July 2012)
- To identify a cohort of discharged patients with potentially actionable results of tests pending at discharge (TPAD).
- To determine if automated email notification of the finalized results of potentially actionable TPADs affects the rate of post-discharge actions taken as documented in the electronic medical record (EMR).
Hypothesis: Automated email notification of the finalized results of potentially actionable TPADs increases the rate of actions taken post-discharge.
Detailed description
Failure to follow up on abnormal test results is a critical problem and is more likely to occur in the case of tests that are performed in the hospital but whose results are not available or not finalized until after discharge (i.e., pending test results). Responsible inpatient and ambulatory providers may not be aware of these test results. In a prior study, Roy et al. determined that 41% of patients were discharged before all laboratory, microbiology, and radiology test results were finalized (31% were collectively hematology, chemistry, and pathology tests, 27% were radiology studies, and 42% were microbiology results). Of these results, 9.4% were considered potentially actionable by independent physician review and could have altered the post-discharge patient care plan. Physicians were only aware of 38% of these test results. Failure to follow-up on these test results can lead to delays in diagnosis, missed treatment opportunities, redundant ordering of tests, and subsequent patient harm. In a hospital the size of Brigham and Women's Hospital (BWH) with 44,000 annual admissions, physicians would be unaware of almost 2000 actionable test results per year. Automated systems can mitigate this problem by ensuring prompt notification of relevant test results finalized after discharge to responsible inpatient and ambulatory providers. Using internal BWH funding, we have developed an automated email notification system to facilitate management of tests pending at discharge (TPADs).
In study 1 (funded by AHRQ), we will prospectively evaluate the impact of this intervention on physician awareness of TPAD results. In study 2 (funded by CRICO), we will perform a chart review to determine the impact of the intervention on downstream actions taken by physicians and acknowledgment of TPAD results as documented in the electronic medical record.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Responsible inpatient and ambulatory physicians assigned to usual care will not receive any email(s) of patients' test results generated from the notification system. |
| Email Notification | Other | Other: Email NotificationResponsible inpatient and ambulatory physicians will receive automated email(s) of patients' tests results finalized post-discharge generated from the notification system. Finalized results will be batched such that no provider will receive more than one email per day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient discharged from selected services at BWH whose inpatient attending and primary care provider are in the same arm of the study.
Key exclusion criteria (1 listed)
- Any patient discharged from selected services at BWH whose inpatient attending and primary care provider are in discordant arms of the study.
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 |
|---|---|---|
| Email NotificationBWH inpatient clinical information systems will automatically file all non-finalized chemistry, hematology, pathology, and radiology tests, as well as inpatient and ambulatory provider email addresses for all study patients discharged. This process will be initiated using a time stamp most proximate to actual discharge time. At midnight on every day, all tests filed at time of discharge will be updated if final results have become available. An email with all finalized and pending test results for each patient discharged will be sent to the inpatient and primary care provider at this time. For patients discharged with more than one pending test, subsequent email notification(s) will be sent out until all pending tests are finalized (no more than one email per day). | Other | Email Notification |
Primary outcome
Percent of Inpatient Providers Aware of Finalized Results of Tests Pending at Discharge (Study 1)
Time frame: 72 hours after notification, October 2010 thru May 2011
The primary outcome will be the percentage of inpatient physicians who are aware of the finalized results of tests pending at discharge.
3 secondary outcomes
Percent of Ambulatory Providers Aware of Finalized Results of Tests Pending at Discharge (Study 1)
Time frame: 72 hours after notification, October 2010 thru May 2011
Percent of Providers Aware of Actionable Test Results (Study 1)
Time frame: 72 hours after notification, October 2010 thru May 2011
Provider Satisfaction (Study 1)
Time frame: 72 hours after notification, October 2010 thru May 2011
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 5 Jun 2013.
- Derived from this study: PubMed 29532297Dalal AK, Schaffer A, Gershanik EF, Papanna R, Eibensteiner K, Nolido NV, Yoon CS, Williams D, Lipsitz SR, Roy CL, Schnipper JL. The Impact of Automated Notification on Follow-up of Actionable Tests Pending at Discharge: a Cluster-Randomized Controlled Trial. J Gen Intern Med. 2018 Jul;33(7):1043-1051. doi: 10.1007/s11606-018-4393-y. Epub 2018 Mar 12.
- Derived from this study: PubMed 24154834Dalal AK, Roy CL, Poon EG, Williams DH, Nolido N, Yoon C, Budris J, Gandhi T, Bates DW, Schnipper JL. Impact of an automated email notification system for results of tests pending at discharge: a cluster-randomized controlled trial. J Am Med Inform Assoc. 2014 May-Jun;21(3):473-80. doi: 10.1136/amiajnl-2013-002030. Epub 2013 Oct 23.
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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.
Anuj K Dalal, MD principal investigator
Brigham and Women'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 Email Notification in people with Test Result Management, run by Brigham and Women'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 5 Jun 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?
Percent of Inpatient Providers Aware of Finalized Results of Tests Pending at Discharge (Study 1) (time frame: 72 hours after notification, October 2010 thru May 2011). 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 NCT01153451, which also lists 2 linked publications.
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 5 Jun 2013.