Pediatric ALLNCT00229671
Medication Errors and Adverse Drug Events (ADEs) in Ambulatory Pediatrics
A study testing Survey 1 and Survey 2 in people with Pediatric ALL, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The purpose of this study is to determine the rates of medication errors in pediatric outpatients in 6 office practices. Further, we wish to determine the effectiveness of a computerized physician order entry (CPOE) system in reducing errors. Read more about this study
- Who is it for?
- Ages 1 day to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric ALL
- What is being tested?
- Survey 1 and Survey 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,341 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to Jul 2005
- 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 1 day to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pediatric providers at the participating office practices during the study period as well as the parents of the patients of these providers.
Who cannot join
- Pediatric providers or patients at other office practices.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02120
About this study
Official title: Ambulatory Medication Errors and Adverse Drug Events (ADEs) in Pediatrics
The purpose of this study is to determine the rates of medication errors in pediatric outpatients in 6 office practices. Further, we wish to determine the effectiveness of a computerized physician order entry (CPOE) system in reducing errors.
Read the detailed description
This study has the following 2 goals:
Aim 1: To determine the rates, types, and predictors of medication errors and ADEs.
Aim 2: To perform a trial assessing the effectiveness of an intervention (CPOE) on reducing serious medication errors.
We hypothesize that:
- Medication errors and ADEs are frequent in ambulatory pediatrics.
- Presence of the following predictors will be associated with higher error rates: cultural, racial, socioeconomic, educational, and linguistic barriers to communication, understanding, and successful completion of prescribed therapies; complex medical or chronic medical conditions; complex medication regimens; non-physician providers with limited clinical experience; high provider workloads; and complex prescription refill systems.
- Prevention strategies, including both technology-based and behavioral/ human factors-based interventions, will be effective and cost-effective in reducing rates of serious medication errors (defined as preventable ADEs and non-intercepted potential ADEs).
- Conditions
- Pediatric ALL
- Being tested
- Survey 1, Survey 2
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey 1Other
During the initial survey, we reviewed dispensed medications by having parents of patients with prescriptions under 21 read the medication label. We then asked questions about potential side effects, method of medication administration, communication regarding the medication with the pharmacist and the health care provider, and demographic information. Research assistants underwent several weeks of training to ensure a standardized approach to surveys.
Survey 2Other
If the parent completed the initial survey, we attempted a second survey 2 months after the index visit to capture persistent symptoms. Surveys were translated and back translated into Spanish and Cambodian and conducted by fluent bilingual interviewers. Surveys were pretested and revised based on 2 focus groups of parents representing a broad array of socioeconomic backgrounds.
| Study group | Role | What they receive |
|---|---|---|
| Patients with prescriptions under 21 | Experimental | Pediatric visits with prescriptions. These patients parents will be given survey 1. Receives: Other: Survey 1 |
| Patients who completed Survey 1 | Experimental | Patients with prescriptions under 21 whose parents complete survey 1 will be given survey 2 Receives: Other: Survey 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Errors
Measured: July 2002- August 2003
Secondary outcomes (1)
Adverse Drug Events
Measured: July 2002- August 2003
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2005 (estimated)
- Study startSep 2001
- Primary completionJul 2004
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ALLStudies 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
- Parallel groups
- Model description
- We performed a prospective cohort study of patients under age 21 from 6 office practices. Data collection methodologies included duplicate prescription review, 2 surveys, and chart review. All data were reviewed for medication errors, including those with the potential for harm (near misses) and those that actually caused harm (preventable ADEs). In addition, data were reviewed for harm from medications that were not associated with an error (nonpreventable ADEs). All ADEs were further characterized according to types and potential prevention strategies.
- Masking
- None (open label)
- Enrolment
- 6,341 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Boston Children's Hospital, The Commonwealth Fund
- Responsible party
- Sponsor
- Investigators
- Rainu Kaushal, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00229671
- Sponsor's protocol ID
- 5P01HS011534-03
- Other IDs
- 2002-P-000544/41; BWH
- Status last verified
- Jun 2018
- First submitted
- 28 Sep 2005
- Last updated
- 25 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: No IPD will be be shared.
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
- Ambulatory Medication Errors and Adverse Drug Events (ADEs) in Pediatrics
- ClinicalTrials.gov ID
- NCT00229671
- Acronym / sponsor ID
- 5P01HS011534-03
- Conditions
- Pediatric ALL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,341 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Boston Children's Hospital, The Commonwealth Fund
- Study start
- Sep 2001 (actual)
- Primary completion
- Jul 2004 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 30 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 purpose of this study is to determine the rates of medication errors in pediatric outpatients in 6 office practices. Further, we wish to determine the effectiveness of a computerized physician order entry (CPOE) system in reducing errors.
Detailed description
This study has the following 2 goals:
Aim 1: To determine the rates, types, and predictors of medication errors and ADEs.
Aim 2: To perform a trial assessing the effectiveness of an intervention (CPOE) on reducing serious medication errors.
We hypothesize that:
- Medication errors and ADEs are frequent in ambulatory pediatrics.
- Presence of the following predictors will be associated with higher error rates: cultural, racial, socioeconomic, educational, and linguistic barriers to communication, understanding, and successful completion of prescribed therapies; complex medical or chronic medical conditions; complex medication regimens; non-physician providers with limited clinical experience; high provider workloads; and complex prescription refill systems.
- Prevention strategies, including both technology-based and behavioral/ human factors-based interventions, will be effective and cost-effective in reducing rates of serious medication errors (defined as preventable ADEs and non-intercepted potential ADEs).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We performed a prospective cohort study of patients under age 21 from 6 office practices. Data collection methodologies included duplicate prescription review, 2 surveys, and chart review. All data were reviewed for medication errors, including those with the potential for harm (near misses) and those that actually caused harm (preventable ADEs). In addition, data were reviewed for harm from medications that were not associated with an error (nonpreventable ADEs). All ADEs were further characterized according to types and potential prevention strategies.
| Arm | Type | Receives |
|---|---|---|
| Patients with prescriptions under 21 | Experimental | Other: Survey 1Pediatric visits with prescriptions. These patients parents will be given survey 1. |
| Patients who completed Survey 1 | Experimental | Other: Survey 2Patients with prescriptions under 21 whose parents complete survey 1 will be given survey 2 |
Who may qualify
- Ages
- 1 day to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Pediatric providers at the participating office practices during the study period as well as the parents of the patients of these providers.
Key exclusion criteria (1 listed)
- Pediatric providers or patients at other office practices.
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 |
|---|---|---|
| Survey 1During the initial survey, we reviewed dispensed medications by having parents of patients with prescriptions under 21 read the medication label. We then asked questions about potential side effects, method of medication administration, communication regarding the medication with the pharmacist and the health care provider, and demographic information. Research assistants underwent several weeks of training to ensure a standardized approach to surveys. | Other | Patients with prescriptions under 21 |
| Survey 2If the parent completed the initial survey, we attempted a second survey 2 months after the index visit to capture persistent symptoms. Surveys were translated and back translated into Spanish and Cambodian and conducted by fluent bilingual interviewers. Surveys were pretested and revised based on 2 focus groups of parents representing a broad array of socioeconomic backgrounds. | Other | Patients who completed Survey 1 |
Primary outcome
Medication Errors
Time frame: July 2002- August 2003
1 secondary outcome
Adverse Drug Events
Time frame: July 2002- August 2003
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.
- Individual participant dataSharing planned: No. No IPD will be be shared.
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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.
Rainu Kaushal principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Survey 1 and Survey 2 in people with Pediatric ALL, 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: July 2002- August 2003). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.