Medication ErrorsNCT00225563
Taconic Health Information Network and Community (THINC)
A study testing Electronic Health Record in people with Medication Errors, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The Taconic IPA, a 2,500 physician independent practice association (IPA) located in Fishkill, New York (NY), is involved in an information technology project to improve the quality, safety and efficiency of healthcare in the region. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medication Errors
- What is being tested?
- Electronic Health Record
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2007to May 2014
- 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
- Physicians' prescriptions and medical records in office practices enrolled in the study
Who cannot join
- Other physicians not enrolled in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transforming Healthcare Quality Through I.T.
The Taconic IPA, a 2,500 physician independent practice association (IPA) located in Fishkill, New York (NY), is involved in an information technology project to improve the quality, safety and efficiency of healthcare in the region. Over the past three years, the organization has worked with area hospitals and laboratories to create a community wide electronic data exchange. Currently, the Taconic IPA is in the midst of implementing a full electronic health record in some practices and e-prescribing in other practices. The purpose is to study the impact of an electronic health record on safety and quality measures.
Read the detailed description
We propose to measure differences in patient safety and quality measures among three groups: the control group consisting of physicians with paper-based office practices, a group of physicians using the clinical messaging system and electronic prescribing, and a group of physicians using the EMR and electronic prescribing.
We plan to introduce a vendor based electronic prescribing system by July 2005. This system will be offered to all physicians using clinical messaging and will be integrated with the EMR system. The system will have clinical decision support, such as checks for drug-drug interactions.
Our evaluation will measure differences in rates of medication errors and quality measures amongst these three groups. We will use a study design of a pre-post evaluation with a comparison control group. We will detect medical errors by prescription and chart review. We will determine compliance with quality measures through a combination of electronic data and chart review.
- Conditions
- Medication Errors
- Being tested
- Electronic Health Record
- Keywords
- Electronic medical records, Electronic prescribing, Quality measures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Health RecordDevice
e-prescribing methods
| Study group | Role | What they receive |
|---|---|---|
| e-prescribing | Active comparator | Providers who used electronic prescriptions. electronic health records were used as opposed to paper based prescriptions Receives: Device: Electronic Health Record |
| Paper-based prescriptions | No intervention | providers who used paper based prescriptions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication errors
Measured: 2007-2012
Near misses
Measured: 2007-2012
Adverse drug events
Measured: 2007-2012
Quality measures
Measured: 2007-2012
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 start21 Jul 2007
- Primary completion25 May 2012
- Study completionMay 2014
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 Medication ErrorsStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Model description
- The study model used pre-post design of 15 providers who adopted e-prescribing with concurrent controls of 15 paper-based providers from September 2005 through June 2007.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- A. John Blair, MD, Principal investigator, Taconic IPARainu Kaushal, MD, Principal investigator, Partners Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00225563
- Sponsor's protocol ID
- 7UC1HS015316-02
- Status last verified
- Jun 2018
- First submitted
- 22 Sep 2005
- Last updated
- 25 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not applicable. no plan to share IPD
Publications
Abramson EL, Barron Y, Quaresimo J, Kaushal R. Electronic prescribing within an electronic health record reduces ambulatory prescribing errors. Jt Comm J Qual Patient Saf. 2011 Oct;37(10):470-8. doi: 10.1016/s1553-7250(11)37060-2.
PubMed 22013821Kaushal R, Kern LM, Barron Y, Quaresimo J, Abramson EL. Electronic prescribing improves medication safety in community-based office practices. J Gen Intern Med. 2010 Jun;25(6):530-6. doi: 10.1007/s11606-009-1238-8. Epub 2010 Feb 26.
PubMed 20186499
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transforming Healthcare Quality Through I.T.
- ClinicalTrials.gov ID
- NCT00225563
- Acronym / sponsor ID
- 7UC1HS015316-02
- Conditions
- Medication Errors
- Keywords
- Electronic medical records, Electronic prescribing, Quality measures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 21 Jul 2007 (actual)
- Primary completion
- 25 May 2012 (actual)
- Study completion
- May 2014 (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.
The Taconic IPA, a 2,500 physician independent practice association (IPA) located in Fishkill, New York (NY), is involved in an information technology project to improve the quality, safety and efficiency of healthcare in the region. Over the past three years, the organization has worked with area hospitals and laboratories to create a community wide electronic data exchange. Currently, the Taconic IPA is in the midst of implementing a full electronic health record in some practices and e-prescribing in other practices. The purpose is to study the impact of an electronic health record on safety and quality measures.
Detailed description
We propose to measure differences in patient safety and quality measures among three groups: the control group consisting of physicians with paper-based office practices, a group of physicians using the clinical messaging system and electronic prescribing, and a group of physicians using the EMR and electronic prescribing.
We plan to introduce a vendor based electronic prescribing system by July 2005. This system will be offered to all physicians using clinical messaging and will be integrated with the EMR system. The system will have clinical decision support, such as checks for drug-drug interactions.
Our evaluation will measure differences in rates of medication errors and quality measures amongst these three groups. We will use a study design of a pre-post evaluation with a comparison control group. We will detect medical errors by prescription and chart review. We will determine compliance with quality measures through a combination of electronic data and chart review.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study model used pre-post design of 15 providers who adopted e-prescribing with concurrent controls of 15 paper-based providers from September 2005 through June 2007.
| Arm | Type | Receives |
|---|---|---|
| e-prescribing | Active comparator | Device: Electronic Health RecordProviders who used electronic prescriptions. electronic health records were used as opposed to paper based prescriptions |
| Paper-based prescriptions | No intervention | –providers who used paper based prescriptions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Physicians' prescriptions and medical records in office practices enrolled in the study
Key exclusion criteria (1 listed)
- Other physicians not enrolled in 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 |
|---|---|---|
| Electronic Health Recorde-prescribing methods | Device | e-prescribing |
Primary outcome
Medication errors
Time frame: 2007-2012
Near misses
Time frame: 2007-2012
Adverse drug events
Time frame: 2007-2012
Quality measures
Time frame: 2007-2012
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 25 Nov 2019.
- Derived from this study: PubMed 22013821Abramson EL, Barron Y, Quaresimo J, Kaushal R. Electronic prescribing within an electronic health record reduces ambulatory prescribing errors. Jt Comm J Qual Patient Saf. 2011 Oct;37(10):470-8. doi: 10.1016/s1553-7250(11)37060-2.
- Derived from this study: PubMed 20186499Kaushal R, Kern LM, Barron Y, Quaresimo J, Abramson EL. Electronic prescribing improves medication safety in community-based office practices. J Gen Intern Med. 2010 Jun;25(6):530-6. doi: 10.1007/s11606-009-1238-8. Epub 2010 Feb 26.
- Individual participant dataSharing planned: No. not applicable. no plan to share IPD
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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.
A. John Blair, MD principal investigator
Taconic IPA
Rainu Kaushal, MD principal investigator
Partners Health Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Health Record in people with Medication Errors, run by Weill Medical College of Cornell University 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 25 Nov 2019. 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?
Medication errors (time frame: 2007-2012). The study lists 4 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 NCT00225563, 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 25 Nov 2019.