Medication ErrorsPhase 2NCT00225576
Statewide Implementation of Electronic Health Records
A Phase 2 study testing Electronic Health Record Implementation in people with Medication Errors, run by Agency for Healthcare Research and Quality (AHRQ) at 1 site in United States.
Trial summary
To determine the effects of Electronic Health Record use on medication error rates in primary care office practices. Hypothesis: Adoption of Electronic Health Records through this program will reduce medication errors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Errors
- What is being tested?
- Electronic Health Record Implementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,030 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Dec 2012
- Phase
- Phase 2
- 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
- All patients of physicians participating in the study
Who cannot join
- Any patients who are not part of a panel of a participating physician
- Any patients who are younger than 18 years of age
- Any patients who came in for a second visit within each data collection period
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02116
About this study
To determine the effects of Electronic Health Record use on medication error rates in primary care office practices.
Hypothesis: Adoption of Electronic Health Records through this program will reduce medication errors
Read the detailed description
From the practices committed to implementing EHR in early 2005, we randomly selected 15 adult community-based primary care physicians. We selected 15 similar physicians in practices that were not planning to adopt in that time period.
At each of these physicians' practices we documented rates of medication errors for one week prior to the implementation of an EHR using duplicate prescription pads. Two months after the implementation in the adopting group, allowing some time for familiarization with the tool, we collected two weeks of data using computer-based information (in the adopting arm) and duplicate prescriptions (in the non-adopting arm).
- Conditions
- Medication Errors
- Being tested
- Electronic Health Record Implementation
- Keywords
- medication errors, adverse drug events, electronic health records
- 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.
Electronic Health Record ImplementationOther
Also called eClinical Works
Intervention subjects implemented electronic prescribing as part of an electronic health record implementation
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Paper prescribing, 2005 and 2007 |
| 2 | Experimental | Paper prescribing 2005 vs. electronic prescribing 2007 Receives: Other: Electronic Health Record Implementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Medication errors
Measured: 2005-2007
2. Near misses
Measured: 2005-2007
3. Adverse drug events
Measured: 2005-2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionNov 2007
- Study completionDec 2012
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 Medication ErrorsStudies 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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 2,030 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Agency for Healthcare Research and Quality (AHRQ)
- Sponsor type
- US federal agency
- Collaborators
- Massachusetts eHealth Collaborative
- Responsible party
- Principal investigator, david bates, Agency for Healthcare Research and Quality (AHRQ)
- Investigators
- David W. Bates, MD, MPH, Principal investigator, Brigham and Women's Hospital, Partners Healthcare System Inc.Rainu Kaushal, MD, MPH, Principal investigator, Cornell Weill Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00225576
- Sponsor's protocol ID
- HS015397
- Status last verified
- Jan 2014
- First submitted
- 22 Sep 2005
- Last updated
- 24 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Abramson EL, Bates DW, Jenter C, Volk LA, Barron Y, Quaresimo J, Seger AC, Burdick E, Simon S, Kaushal R. Ambulatory prescribing errors among community-based providers in two states. J Am Med Inform Assoc. 2012 Jul-Aug;19(4):644-8. doi: 10.1136/amiajnl-2011-000345. Epub 2011 Dec 1.
PubMed 22140209
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Statewide Implementation of Electronic Health Records
- ClinicalTrials.gov ID
- NCT00225576
- Acronym / sponsor ID
- HS015397
- Conditions
- Medication Errors
- Keywords
- medication errors, adverse drug events, electronic health records
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,030 participants (estimated)
- Lead sponsor
- Agency for Healthcare Research and Quality (AHRQ)US federal agency
- Collaborators
- Massachusetts eHealth Collaborative
- Study start
- Sep 2005
- Primary completion
- Nov 2007 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 26 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.
To determine the effects of Electronic Health Record use on medication error rates in primary care office practices.
Hypothesis: Adoption of Electronic Health Records through this program will reduce medication errors
Detailed description
From the practices committed to implementing EHR in early 2005, we randomly selected 15 adult community-based primary care physicians. We selected 15 similar physicians in practices that were not planning to adopt in that time period.
At each of these physicians' practices we documented rates of medication errors for one week prior to the implementation of an EHR using duplicate prescription pads. Two months after the implementation in the adopting group, allowing some time for familiarization with the tool, we collected two weeks of data using computer-based information (in the adopting arm) and duplicate prescriptions (in the non-adopting arm).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Paper prescribing, 2005 and 2007 |
| 2 | Experimental | Other: Electronic Health Record ImplementationPaper prescribing 2005 vs. electronic prescribing 2007 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients of physicians participating in the study
Key exclusion criteria (3 listed)
- Any patients who are not part of a panel of a participating physician
- Any patients who are younger than 18 years of age
- Any patients who came in for a second visit within each data collection period
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 |
|---|---|---|
| Electronic Health Record ImplementationAlso: eClinical WorksIntervention subjects implemented electronic prescribing as part of an electronic health record implementation | Other | 2 |
Primary outcome
1. Medication errors
Time frame: 2005-2007
2. Near misses
Time frame: 2005-2007
3. Adverse drug events
Time frame: 2005-2007
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 24 Jan 2014.
- Derived from this study: PubMed 22140209Abramson EL, Bates DW, Jenter C, Volk LA, Barron Y, Quaresimo J, Seger AC, Burdick E, Simon S, Kaushal R. Ambulatory prescribing errors among community-based providers in two states. J Am Med Inform Assoc. 2012 Jul-Aug;19(4):644-8. doi: 10.1136/amiajnl-2011-000345. Epub 2011 Dec 1.
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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.
David W. Bates, MD, MPH principal investigator
Brigham and Women's Hospital, Partners Healthcare System Inc.
Rainu Kaushal, MD, MPH principal investigator
Cornell Weill Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Electronic Health Record Implementation in people with Medication Errors, run by Agency for Healthcare Research and Quality (AHRQ) 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 3 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 24 Jan 2014. 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.
What does this 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.
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?
1. Medication errors (time frame: 2005-2007). The study lists 3 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 NCT00225576, 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 24 Jan 2014.