Electronic PrescribingPhase 4NCT00252395
Evaluation of Electronic Prescribing in Hospital Ambulatory Care Clinics
A Phase 4 study testing PDA-based Electronic Prescribing Software in people with Electronic Prescribing, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
All reliably evaluated POE systems to date have been desktop computer based, but now there is widespread use and acceptance among physicians of PDA devices for a variety of purposes. Read more about this study
- Who is it for?
- Ages 0 years and olderHealthy volunteers can take part
- Conditions the study is for
- Electronic Prescribing
- What is being tested?
- PDA-based Electronic Prescribing Software
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2005to Aug 2006
- Phase
- Phase 4
- 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 0 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- active staff physician at Sunnybrook \& Women's College HSC
Who cannot join
- inadequate prescribing practice (minimum number)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Sunnybrook & Women's College Health Science Centre
Toronto, Ontario, M4N 3M5
About this study
Official title: Effects of Electronic Prescribing on Safety and Quality in Hospital-Based Ambulatory Are: a Randomised Controlled Trial
All reliably evaluated POE systems to date have been desktop computer based, but now there is widespread use and acceptance among physicians of PDA devices for a variety of purposes. Clinicians report that drug information on a PDA improved their access to information and efficiency while reducing their self perceived error rates6. The use of these devices for information retrieval in clinical settings is expected to grow as wireless communication becomes more ubiquitous and as more applications become available6,7. During the past decade there has been a growing awareness of several issues aimed at promoting safer health care for our patients - point of care information technology is one of the keys.
To this end we have worked with a Canadian company, Drugmagnet, to develop and implement PDA-based electronic prescribing system within a major Canadian academic health centre. This is a cluster randomised trial, in which access to and use of the e-prescribing system is switched on and off for randomly chosen weeks, thus time serves as the randomized element.
- Conditions
- Electronic Prescribing
- Being tested
- PDA-based Electronic Prescribing Software
- Keywords
- medication error, electronic prescribing, patient safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDA-based Electronic Prescribing SoftwareDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Total prescribing error, as measured by the number of call backs received from pharmacists.
Secondary outcomes (4)
a) Interactions
b) Dosing and route of administration errors
c) Pack errors
d) Legibility errors
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2005 (estimated)
- Study startAug 2005
- Study completionAug 2006
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 Electronic PrescribingStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe 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 4
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Health Canada
- Investigators
- Merrick F Zwarenstein, MBBCH, Study director, Institute for Clinical Evaluative ScienceWilliam J Sibbald, MD, MPH, Principal investigator, Sunnybrook & Women's College Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00252395
- Sponsor's protocol ID
- S&W e-RX
- Other IDs
- 6804-15-2003/5590024
- Status last verified
- Nov 2005
- First submitted
- 9 Nov 2005
- Last updated
- 11 Nov 2005
- Results posted
- No
Publications
Dainty KN, Adhikari NK, Kiss A, Quan S, Zwarenstein M. Electronic prescribing in an ambulatory care setting: a cluster randomized trial. J Eval Clin Pract. 2012 Aug;18(4):761-7. doi: 10.1111/j.1365-2753.2011.01657.x. Epub 2011 Mar 18.
PubMed 21414109Zwarenstein MF, Dainty KN, Quan S, Kiss A, Adhikari NK. A cluster randomized trial evaluating electronic prescribing in an ambulatory care setting. Trials. 2007 Oct 3;8:28. doi: 10.1186/1745-6215-8-28.
PubMed 17915028
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Electronic Prescribing on Safety and Quality in Hospital-Based Ambulatory Are: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT00252395
- Acronym / sponsor ID
- S&W e-RX
- Conditions
- Electronic Prescribing
- Keywords
- medication error, electronic prescribing, patient safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Health Canada
- Study start
- Aug 2005
- Study completion
- Aug 2006
- First posted
- 11 Nov 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.
All reliably evaluated POE systems to date have been desktop computer based, but now there is widespread use and acceptance among physicians of PDA devices for a variety of purposes. Clinicians report that drug information on a PDA improved their access to information and efficiency while reducing their self perceived error rates6. The use of these devices for information retrieval in clinical settings is expected to grow as wireless communication becomes more ubiquitous and as more applications become available6,7. During the past decade there has been a growing awareness of several issues aimed at promoting safer health care for our patients - point of care information technology is one of the keys.
To this end we have worked with a Canadian company, Drugmagnet, to develop and implement PDA-based electronic prescribing system within a major Canadian academic health centre. This is a cluster randomised trial, in which access to and use of the e-prescribing system is switched on and off for randomly chosen weeks, thus time serves as the randomized element.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- active staff physician at Sunnybrook \& Women's College HSC
Key exclusion criteria (1 listed)
- inadequate prescribing practice (minimum number)
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 |
|---|---|---|
| PDA-based Electronic Prescribing Software | Device | – |
Primary outcome
Total prescribing error, as measured by the number of call backs received from pharmacists.
4 secondary outcomes
a) Interactions
b) Dosing and route of administration errors
c) Pack errors
d) Legibility errors
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 11 Nov 2005.
- Derived from this study: PubMed 21414109Dainty KN, Adhikari NK, Kiss A, Quan S, Zwarenstein M. Electronic prescribing in an ambulatory care setting: a cluster randomized trial. J Eval Clin Pract. 2012 Aug;18(4):761-7. doi: 10.1111/j.1365-2753.2011.01657.x. Epub 2011 Mar 18.
- Derived from this study: PubMed 17915028Zwarenstein MF, Dainty KN, Quan S, Kiss A, Adhikari NK. A cluster randomized trial evaluating electronic prescribing in an ambulatory care setting. Trials. 2007 Oct 3;8:28. doi: 10.1186/1745-6215-8-28.
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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.
Merrick F Zwarenstein, MBBCH study director
Institute for Clinical Evaluative Science
William J Sibbald, MD, MPH principal investigator
Sunnybrook & Women's College Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PDA-based Electronic Prescribing Software in people with Electronic Prescribing, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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 11 Nov 2005. 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 Canada. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Total prescribing error, as measured by the number of call backs received from pharmacists.. 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 NCT00252395, 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 11 Nov 2005.