Impact of Electronic Prescribing on Medication SafetyNCT00235027
Improving Safety By Computerizing Outpatient Prescribing
A study testing Adverse Drug Event Monitoring in people with Impact of Electronic Prescribing on Medication Safety, run by Agency for Healthcare Research and Quality (AHRQ) at 2 sites in United States.
Trial summary
Patient safety is at the forefront of critical issues in health care. Medications are the single most frequent cause of adverse events, and in the inpatient setting adverse drug events (ADEs) are common, expensive, injurious to patients, and often preventable. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Impact of Electronic Prescribing on Medication Safety
- What is being tested?
- Adverse Drug Event Monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 701 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2000to Dec 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Clinics not using electronic medical records
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Regenstrief/Indiana University
Indianapolis, Indiana
About this study
Patient safety is at the forefront of critical issues in health care. Medications are the single most frequent cause of adverse events, and in the inpatient setting adverse drug events (ADEs) are common, expensive, injurious to patients, and often preventable. Relatively little, however, is known about the frequency of ADEs in the ambulatory setting, how to monitor for outpatient ADEs, or on the impact of prevention strategies such as computerization of prescribing supplemented by decision-support.
Read the detailed description
Specific Aim 1: Increase routine identification of outpatient adverse drug events (ADEs) through development of a computerized ADE detection monitor.
Specific Aim 2: Use basic computerized outpatient prescribing to reduce preventable ADEs in a diverse array of outpatient settings.
Specific Aim 3: Use advanced decision-support within computerized prescribing to reduce the frequency of preventable ADEs, medication errors, and potential ADEs.
- Being tested
- Adverse Drug Event Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adverse Drug Event MonitoringOther
The intervention in this study is the presentation of medication safety alerts in the electronic medical record to improve patient outcomes and safety.
| Study group | Role | What they receive |
|---|---|---|
| Adverse Drug Event Monitoring | Experimental | In this intervention arm, clinicians received medication safety alerts when they prescribed medications in the electronic medical record. Receives: Other: Adverse Drug Event Monitoring |
| Care as Usual | No intervention | In this arm, clinicians did not receive the medication safety alerts. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preventable Adverse drug events
Data were electronically collected each time a physician entered a prescription that triggered an alert related to medication safety.
Measured: 8/5/2004 - 1/5/2005
Secondary outcomes (1)
Total adverse drug events, medication errors
Measured: 1/15/2001 - 5/15/2001
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2005 (estimated)
- Study startAug 2000
- Primary completionDec 2010
- Study completionDec 2010
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 Impact of Electronic Prescribing on Medication SafetyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 701 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agency for Healthcare Research and Quality (AHRQ)
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, david bates, Agency for Healthcare Research and Quality (AHRQ)
- Investigators
- Tejal K Gandhi, MD, MPH, Study director, Brigham and Women's HospitalDavid Bates, MD, Principal investigator, Brigham and Women's HospitalMarc Overhage, MD, Study director, Regenstrief Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00235027
- Sponsor's protocol ID
- RO1 HS 11169
- Status last verified
- Jul 2015
- First submitted
- 6 Oct 2005
- Last updated
- 21 Jul 2015
- Results posted
- No
Publications
Shah NR, Seger AC, Seger DL, Fiskio JM, Kuperman GJ, Blumenfeld B, Recklet EG, Bates DW, Gandhi TK. Improving acceptance of computerized prescribing alerts in ambulatory care. J Am Med Inform Assoc. 2006 Jan-Feb;13(1):5-11. doi: 10.1197/jamia.M1868. Epub 2005 Oct 12.
PubMed 16221941Gandhi TK, Seger AC, Overhage JM, Murray MD, Hope C, Fiskio J, Teal E, Bates DW. Outpatient adverse drug events identified by screening electronic health records. J Patient Saf. 2010 Jun;6(2):91-6. doi: 10.1097/PTS.0b013e3181dcae06.
PubMed 22130350
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Safety By Computerizing Outpatient Prescribing
- ClinicalTrials.gov ID
- NCT00235027
- Acronym / sponsor ID
- RO1 HS 11169
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 701 participants (actual)
- Lead sponsor
- Agency for Healthcare Research and Quality (AHRQ)US federal agency
- Study start
- Aug 2000
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 10 Oct 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.
Patient safety is at the forefront of critical issues in health care. Medications are the single most frequent cause of adverse events, and in the inpatient setting adverse drug events (ADEs) are common, expensive, injurious to patients, and often preventable. Relatively little, however, is known about the frequency of ADEs in the ambulatory setting, how to monitor for outpatient ADEs, or on the impact of prevention strategies such as computerization of prescribing supplemented by decision-support.
Detailed description
Specific Aim 1: Increase routine identification of outpatient adverse drug events (ADEs) through development of a computerized ADE detection monitor.
Specific Aim 2: Use basic computerized outpatient prescribing to reduce preventable ADEs in a diverse array of outpatient settings.
Specific Aim 3: Use advanced decision-support within computerized prescribing to reduce the frequency of preventable ADEs, medication errors, and potential ADEs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adverse Drug Event Monitoring | Experimental | Other: Adverse Drug Event MonitoringIn this intervention arm, clinicians received medication safety alerts when they prescribed medications in the electronic medical record. |
| Care as Usual | No intervention | –In this arm, clinicians did not receive the medication safety alerts. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Clinics not using electronic medical records
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 |
|---|---|---|
| Adverse Drug Event MonitoringThe intervention in this study is the presentation of medication safety alerts in the electronic medical record to improve patient outcomes and safety. | Other | Adverse Drug Event Monitoring |
Primary outcome
Preventable Adverse drug events
Time frame: 8/5/2004 - 1/5/2005
Data were electronically collected each time a physician entered a prescription that triggered an alert related to medication safety.
1 secondary outcome
Total adverse drug events, medication errors
Time frame: 1/15/2001 - 5/15/2001
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 21 Jul 2015.
- Results publication: PubMed 16221941Shah NR, Seger AC, Seger DL, Fiskio JM, Kuperman GJ, Blumenfeld B, Recklet EG, Bates DW, Gandhi TK. Improving acceptance of computerized prescribing alerts in ambulatory care. J Am Med Inform Assoc. 2006 Jan-Feb;13(1):5-11. doi: 10.1197/jamia.M1868. Epub 2005 Oct 12.
- Results publication: PubMed 22130350Gandhi TK, Seger AC, Overhage JM, Murray MD, Hope C, Fiskio J, Teal E, Bates DW. Outpatient adverse drug events identified by screening electronic health records. J Patient Saf. 2010 Jun;6(2):91-6. doi: 10.1097/PTS.0b013e3181dcae06.
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 study director
Brigham and Women's Hospital
David Bates, MD principal investigator
Brigham and Women's Hospital
Marc Overhage, MD study director
Regenstrief Institute, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adverse Drug Event Monitoring in people with Impact of Electronic Prescribing on Medication Safety, run by Agency for Healthcare Research and Quality (AHRQ) 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 0 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 21 Jul 2015. 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.
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?
Preventable Adverse drug events (time frame: 8/5/2004 - 1/5/2005). 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 NCT00235027, 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 21 Jul 2015.