Adverse Drug EventsPhase 2/3NCT01091038
Improving Safety by Basic Computerizing Outpatient Prescribing
A Phase 2/3 study testing Basic Clinical Decision Support and Routine Care in people with Adverse Drug Events, run by Indiana University at 2 sites in United States.
Trial summary
The study will measure the effect of basic clinical decision support on medical errors and adverse drug events in the ambulatory setting. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adverse Drug Events
- What is being tested?
- Basic Clinical Decision Support and Routine Care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 228 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2001to Aug 2007
- Phase
- Phase 2/3
- 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 Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- provider practicing at sites implementing order entry with basic clinical decision support using either the longitudinal medical record (LMR) or Medical Gopher
Who cannot join
- provider or practice unwilling to participate
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Partner's Healthcare
Boston, Massachusetts, 02115
Wishard Helath Services
Indianapolis, Indiana, 46202
About this study
The study will measure the effect of basic clinical decision support on medical errors and adverse drug events in the ambulatory setting.
- Conditions
- Adverse Drug Events
- Being tested
- Basic Clinical Decision Support, Routine Care
- Keywords
- Adverse drug events, medical errors, computerized physician order entry, clinical decision support
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basic Clinical Decision SupportOther
The computerized physician order entry (CPOE) intervention provides physicians with a menu of medications from the formulary, default doses, and a range of potential doses for each medication. Physicians were required to enter dosage, route, and frequency for all orders. Also, CPOE ensured that all orders were legible and included the prescribing physician's signature. For a number of medications, the system displayed relevant laboratory results on the screen at the time of ordering. Other features included consequent orders, which are orders that should follow from other orders, and drug-allergy checking, drug-drug interaction checking, and drug-laboratory checking. This included checking for the most frequent drug allergies, about 80 carefully selected drug-drug interactions, and several drug-laboratory combinations
Routine CareOther
Routine Care
| Study group | Role | What they receive |
|---|---|---|
| Routine Care | Placebo comparator | Usual care of patients in the ambulatory setting Receives: Other: Routine Care |
| Basic Clinical Decision Support | Experimental | Providers use basic clinical decision support Receives: Other: Basic Clinical Decision Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Drug Events
Adverse drug events are measured through use of a computerized surveillance system augmented by focused structured human review
Measured: 6 months
Medical Errors
Medical Errors are identified through a computerized surveillance system with structured human review
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2010 (estimated)
- Study startAug 2001
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adverse Drug EventsStudies 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 2/3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Investigators
- Joseph M Overhage, MD, PhD, Principal investigator, Indiana UniversityDavid Bates, MD, Principal investigator, Brigham and Women's HospitalTejal Gandhi, MD, Principal investigator, Brigham and Women's HospitalAndrew Seger, PharmD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01091038
- Sponsor's protocol ID
- 0008-44
- Status last verified
- Oct 2023
- First submitted
- 19 Mar 2010
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Hope C, Overhage JM, Seger A, Teal E, Mills V, Fiskio J, Gandhi TK, Bates DW, Murray MD. A tiered approach is more cost effective than traditional pharmacist-based review for classifying computer-detected signals as adverse drug events. J Biomed Inform. 2003 Feb-Apr;36(1-2):92-8. doi: 10.1016/s1532-0464(03)00059-5.
PubMed 14552850
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Safety by Basic Computerizing Outpatient Prescribing
- ClinicalTrials.gov ID
- NCT01091038
- Acronym / sponsor ID
- 0008-44
- Conditions
- Adverse Drug Events
- Keywords
- Adverse drug events, medical errors, computerized physician order entry, clinical decision support
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Study start
- Aug 2001
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 23 Mar 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 study will measure the effect of basic clinical decision support on medical errors and adverse drug events in the ambulatory setting.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine Care | Placebo comparator | Other: Routine CareUsual care of patients in the ambulatory setting |
| Basic Clinical Decision Support | Experimental | Other: Basic Clinical Decision SupportProviders use basic clinical decision support |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- provider practicing at sites implementing order entry with basic clinical decision support using either the longitudinal medical record (LMR) or Medical Gopher
Key exclusion criteria (1 listed)
- provider or practice unwilling to participate
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 |
|---|---|---|
| Basic Clinical Decision SupportThe computerized physician order entry (CPOE) intervention provides physicians with a menu of medications from the formulary, default doses, and a range of potential doses for each medication. Physicians were required to enter dosage, route, and frequency for all orders. Also, CPOE ensured that all orders were legible and included the prescribing physician's signature. For a number of medications, the system displayed relevant laboratory results on the screen at the time of ordering. Other features included consequent orders, which are orders that should follow from other orders, and drug-allergy checking, drug-drug interaction checking, and drug-laboratory checking. This included checking for the most frequent drug allergies, about 80 carefully selected drug-drug interactions, and several drug-laboratory combinations | Other | Basic Clinical Decision Support |
| Routine CareRoutine Care | Other | Routine Care |
Primary outcome
Adverse Drug Events
Time frame: 6 months
Adverse drug events are measured through use of a computerized surveillance system augmented by focused structured human review
Medical Errors
Time frame: 6 months
Medical Errors are identified through a computerized surveillance system with structured human review
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 12 Oct 2023.
- Background: PubMed 14552850Hope C, Overhage JM, Seger A, Teal E, Mills V, Fiskio J, Gandhi TK, Bates DW, Murray MD. A tiered approach is more cost effective than traditional pharmacist-based review for classifying computer-detected signals as adverse drug events. J Biomed Inform. 2003 Feb-Apr;36(1-2):92-8. doi: 10.1016/s1532-0464(03)00059-5.
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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.
Joseph M Overhage, MD, PhD principal investigator
Indiana University
David Bates, MD principal investigator
Brigham and Women's Hospital
Tejal Gandhi, MD 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 2/3 study testing Basic Clinical Decision Support and Routine Care in people with Adverse Drug Events, run by Indiana University 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 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 12 Oct 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
What does the primary outcome measure?
Adverse Drug Events (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT01091038, which also lists 1 linked publication.
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 12 Oct 2023.