Medication ErrorsNCT00134823
Improving Pediatric Safety and Quality With Health Care Information Technology
A study testing weight based dosing decision support in people with Medication Errors and Medical Records Systems, Computerized, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study includes four projects aimed to improve the quality and safety of pediatric care through the implementation of four clinical decision support services in the electronic health record (EHR). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Medication Errors, Medical Records Systems, Computerized, Patient Safety
- What is being tested?
- weight based dosing decision support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,420 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Sep 2008
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Partners-affiliated pediatric practice providers utilizing Longitudinal Medical Record (LMR), which is an electronic health record system. Also the parents of the patients of the above noted pediatric providers.
Who cannot join
- Non-Partners providers, or Partners providers who do not use LMR. Parents of patients not seen by Partners-affiliated pediatric providers who use LMR.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital/Partners HealthCare
Boston, Massachusetts, 02114
About this study
Official title: Improving Pediatric Safety and Quality With Health Care IT
This study includes four projects aimed to improve the quality and safety of pediatric care through the implementation of four clinical decision support services in the electronic health record (EHR). The four projects will measure the effect of each clinical decision support feature including: weight-based dosing; smart forms for chronic conditions; guideline reminders; and a results manager to track abnormal lab result follow-up.
Hypothesis: Implementation of the clinical decision support features will decrease medication errors and adverse drug events, assist physicians in adhering to clinical practice guidelines and protocols for certain chronic illnesses, improve physician follow-up for abnormal lab results, and overall improve the safety and quality of pediatric clinical practice.
Read the detailed description
please see description above
- Conditions
- Medication Errors, Medical Records Systems, Computerized, Patient Safety, Quality Improvement
- Being tested
- weight based dosing decision support
- Keywords
- Parent Experience of Care, Quality Improvement, Medication Errors, Abnormal Lab Values, Guideline Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
weight based dosing decision supportOther
weight based dosing decision support
| Study group | Role | What they receive |
|---|---|---|
| dosing decision support | Experimental | weight based dosing decision support Receives: Other: weight based dosing decision support |
| no decision support | No intervention | no weight based dosing decision support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact on rates of medication errors
difference in weight related medication prescribing errors by drug class
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2005 (estimated)
- Study startMar 2005
- Primary completionSep 2008
- Study completionSep 2008
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 Massachusetts General 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
- None (open label)
- Enrolment
- 5,420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Investigators
- Timothy G Ferris, MD, MPH, Principal investigator, Massachusetts General Hospital, Partners Healthcare System Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00134823
- Sponsor's protocol ID
- 2004-P-002027
- Other IDs
- HS015002-01
- Status last verified
- Jul 2011
- First submitted
- 23 Aug 2005
- Last updated
- 21 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Bourgeois FC, Linder J, Johnson SA, Co JP, Fiskio J, Ferris TG. Impact of a computerized template on antibiotic prescribing for acute respiratory infections in children and adolescents. Clin Pediatr (Phila). 2010 Oct;49(10):976-83. doi: 10.1177/0009922810373649. Epub 2010 Aug 19.
PubMed 20724348Co JP, Johnson SA, Poon EG, Fiskio J, Rao SR, Van Cleave J, Perrin JM, Ferris TG. Electronic health record decision support and quality of care for children with ADHD. Pediatrics. 2010 Aug;126(2):239-46. doi: 10.1542/peds.2009-0710. Epub 2010 Jul 19.
PubMed 20643719
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Pediatric Safety and Quality With Health Care IT
- ClinicalTrials.gov ID
- NCT00134823
- Acronym / sponsor ID
- 2004-P-002027
- Conditions
- Medication Errors, Medical Records Systems, Computerized, Patient Safety, Quality Improvement
- Keywords
- Parent Experience of Care, Quality Improvement, Medication Errors, Abnormal Lab Values, Guideline Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,420 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Mar 2005
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 25 Aug 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.
This study includes four projects aimed to improve the quality and safety of pediatric care through the implementation of four clinical decision support services in the electronic health record (EHR). The four projects will measure the effect of each clinical decision support feature including: weight-based dosing; smart forms for chronic conditions; guideline reminders; and a results manager to track abnormal lab result follow-up.
Hypothesis: Implementation of the clinical decision support features will decrease medication errors and adverse drug events, assist physicians in adhering to clinical practice guidelines and protocols for certain chronic illnesses, improve physician follow-up for abnormal lab results, and overall improve the safety and quality of pediatric clinical practice.
Detailed description
please see description above
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dosing decision support | Experimental | Other: weight based dosing decision supportweight based dosing decision support |
| no decision support | No intervention | –no weight based dosing decision support |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Partners-affiliated pediatric practice providers utilizing Longitudinal Medical Record (LMR), which is an electronic health record system. Also the parents of the patients of the above noted pediatric providers.
Key exclusion criteria (1 listed)
- Non-Partners providers, or Partners providers who do not use LMR. Parents of patients not seen by Partners-affiliated pediatric providers who use LMR.
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 |
|---|---|---|
| weight based dosing decision supportweight based dosing decision support | Other | dosing decision support |
Primary outcome
Impact on rates of medication errors
Time frame: 1 year
difference in weight related medication prescribing errors by drug class
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 2011.
- Derived from this study: PubMed 20724348Bourgeois FC, Linder J, Johnson SA, Co JP, Fiskio J, Ferris TG. Impact of a computerized template on antibiotic prescribing for acute respiratory infections in children and adolescents. Clin Pediatr (Phila). 2010 Oct;49(10):976-83. doi: 10.1177/0009922810373649. Epub 2010 Aug 19.
- Derived from this study: PubMed 20643719Co JP, Johnson SA, Poon EG, Fiskio J, Rao SR, Van Cleave J, Perrin JM, Ferris TG. Electronic health record decision support and quality of care for children with ADHD. Pediatrics. 2010 Aug;126(2):239-46. doi: 10.1542/peds.2009-0710. Epub 2010 Jul 19.
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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.
Timothy G Ferris, MD, MPH principal investigator
Massachusetts General Hospital, Partners Healthcare System Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing weight based dosing decision support in people with Medication Errors and Medical Records Systems, Computerized, run by Massachusetts General 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 21 Jul 2011. 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?
Impact on rates of medication errors (time frame: 1 year). 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 NCT00134823, 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 2011.