TeratogensPREVENTNCT00766207
Electronic Notification of Teratogenic Risks
A study testing Clinical decision support and stream-lined clinical alert in people with Teratogens and Abnormalities, Drug-Induced, run by University of Pittsburgh at 4 sites in United States.
Trial summary
This study will use a factorial design randomized controlled trial to (1)compare multi-faceted decision support (intervention) to streamlined clinical alerts (control) and (2) evaluate whether collecting information about women's risk of pregnancy using a networked tablet computer (intervention) is superior to the way… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Teratogens, Abnormalities, Drug-Induced, Contraception
- What is being tested?
- Clinical decision support and stream-lined clinical alert
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,593 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2008to May 2011
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18-45 seen at a participating primary care clinic
Who cannot join
- Non-English speakers
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Partners in Health
Delmont, Pennsylvania, 15626
Partners in Health
Level Green, Pennsylvania, 15085
Partners in Health
Murrysville, Pennsylvania, 15085
General Internal Medicine Oakland (GIMO) Practice
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Preconception Risk Evaluation Via Electronic Medical Record Notification of Teratogenic Risks
This study will use a factorial design randomized controlled trial to (1)compare multi-faceted decision support (intervention) to streamlined clinical alerts (control) and (2) evaluate whether collecting information about women's risk of pregnancy using a networked tablet computer (intervention) is superior to the way clinicians usually collect this information (control).
Over the course of 1 year, we will abstract data from the electronic medical record when study clinicians prescribe teratogenic medications, conduct phone interviews with women prescribed medications by participating clinicians, and survey participating clinicians about their satisfaction with the decision support they receive. We will use this data to confirm our hypotheses that clinicians in the intervention groups will (1) prescribe fewer teratogenic medications, (2) be more likely to prescribe contraception when a teratogenic medication is prescribed, (3) have more patients report satisfaction with the counseling they received, and (4) report more satisfaction with the decision support they received.
- Conditions
- Teratogens, Abnormalities, Drug-Induced, Contraception
- Being tested
- Clinical decision support, stream-lined clinical alert
- Keywords
- Teratogens, Abnormalities, Drug-Induced, Contraception
- Medical subject headings
- Abnormalities, Drug-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical decision supportOther
multi-faceted decision support
stream-lined clinical alertOther
electronic notification that a medication is potentially teratogenic
| Study group | Role | What they receive |
|---|---|---|
| multi-faceted decision support | Experimental | Multi-faceted decision support Receives: Other: Clinical decision support |
| control | Active comparator | stream-lined clinical alert Receives: Other: stream-lined clinical alert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of women prescribed potentially teratogenic medications with documented use of contraception
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 posted3 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionApr 2010
- Study completionMay 2011
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 TeratogensStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,593 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Investigators
- Eleanor B Schwarz, MD, MS, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00766207
- Sponsor's protocol ID
- R18HS017093-01
- Other IDs
- 1R18HS017093-01
- Acronym
- PREVENT
- Status last verified
- May 2011
- First submitted
- 1 Oct 2008
- Last updated
- 12 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schwarz EB, Parisi SM, Handler SM, Koren G, Cohen ED, Shevchik GJ, Fischer GS. Clinical decision support to promote safe prescribing to women of reproductive age: a cluster-randomized trial. J Gen Intern Med. 2012 Jul;27(7):831-8. doi: 10.1007/s11606-012-1991-y.
PubMed 22297687
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preconception Risk Evaluation Via Electronic Medical Record Notification of Teratogenic Risks
- ClinicalTrials.gov ID
- NCT00766207
- Acronym / sponsor ID
- PREVENT / R18HS017093-01
- Conditions
- Teratogens, Abnormalities, Drug-Induced, Contraception
- Keywords
- Teratogens, Abnormalities, Drug-Induced, Contraception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,593 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Oct 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 3 Oct 2008 (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 will use a factorial design randomized controlled trial to (1)compare multi-faceted decision support (intervention) to streamlined clinical alerts (control) and (2) evaluate whether collecting information about women's risk of pregnancy using a networked tablet computer (intervention) is superior to the way clinicians usually collect this information (control).
Over the course of 1 year, we will abstract data from the electronic medical record when study clinicians prescribe teratogenic medications, conduct phone interviews with women prescribed medications by participating clinicians, and survey participating clinicians about their satisfaction with the decision support they receive. We will use this data to confirm our hypotheses that clinicians in the intervention groups will (1) prescribe fewer teratogenic medications, (2) be more likely to prescribe contraception when a teratogenic medication is prescribed, (3) have more patients report satisfaction with the counseling they received, and (4) report more satisfaction with the decision support they received.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| multi-faceted decision support | Experimental | Other: Clinical decision supportMulti-faceted decision support |
| control | Active comparator | Other: stream-lined clinical alertstream-lined clinical alert |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women aged 18-45 seen at a participating primary care clinic
Key exclusion criteria (1 listed)
- Non-English speakers
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 |
|---|---|---|
| Clinical decision supportmulti-faceted decision support | Other | multi-faceted decision support |
| stream-lined clinical alertelectronic notification that a medication is potentially teratogenic | Other | control |
Primary outcome
Proportion of women prescribed potentially teratogenic medications with documented use of contraception
Time frame: 1 year
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 12 May 2011.
- Derived from this study: PubMed 22297687Schwarz EB, Parisi SM, Handler SM, Koren G, Cohen ED, Shevchik GJ, Fischer GS. Clinical decision support to promote safe prescribing to women of reproductive age: a cluster-randomized trial. J Gen Intern Med. 2012 Jul;27(7):831-8. doi: 10.1007/s11606-012-1991-y.
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.
Eleanor B Schwarz, MD, MS principal investigator
University of Pittsburgh
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical decision support and stream-lined clinical alert in people with Teratogens and Abnormalities, Drug-Induced, run by University of Pittsburgh at 4 sites 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 12 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Proportion of women prescribed potentially teratogenic medications with documented use of contraception (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 NCT00766207, 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 12 May 2011.