DiseaseNCT01043133
Study of Medical Student Use of Templates to Document Outpatient Asthma Care in Electronic Medical Record
A study testing social marketing-based medical education intervention in people with Disease, run by Uniformed Services University of the Health Sciences.
Trial summary
The purpose of the study is to measure the effectiveness of a social marketing-based medical education intervention on student use of evidence-based templates for documenting outpatient asthma care within an electronic medical record. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Disease
- What is being tested?
- social marketing-based medical education intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- No sites listed yet
- Study dates
- Jul 2009to Jun 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Third year medical student completing family medicine clerkship Uniformed Services University
Who cannot join
- All students other than those listed above
About this study
Official title: Social Marketing in Medical Education: Influencing Medical Student Use of Evidence-based Templates in Outpatient Documentation of Asthma Care Using an Electronic Medical Record
The purpose of the study is to measure the effectiveness of a social marketing-based medical education intervention on student use of evidence-based templates for documenting outpatient asthma care within an electronic medical record.
Read the detailed description
The purpose of the study was to measure the effectiveness of a physician-educator led clinical documentation workshop, embedded with 7 persuasive social-marketing based messages, on medical student response using a targeted asthma template. Stated differently, whether a physician-educator could "persuade" medical students to use an evidence-based EMR asthma template to document an outpatient mild persistent asthma encounter with a patient.
- Conditions
- Disease
- Being tested
- social marketing-based medical education intervention
- Keywords
- electronic medical records, documentation templates, clinical encounter notes
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
social marketing-based medical education interventionBehavioural
Also called persuasion
social-marketing based medical education intervention designed to influence medical student use of evidence-based templates. Led by physician instructor.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Behavioral: social marketing-based medical education intervention |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Using Evidence-based Template to Document Asthma Care Within an Electronic Medical Record
The primary outcome measure is a count of whether or not the research participant uses the electronic health record-based Asthma AIM form to document a simulated outpatient mild persistent asthma encounter at T1 (immediately following intervention) and T2 (upon completion of family medicine clerkship approximately 35 days later).
Measured: immediately after invervention and 30+ days in follow-up
Secondary outcomes (1)
Clinical Note Completeness Score
The Note Completeness Score is a total score (range 1-31)earned when a clinical encounter note is compared against a note completeness score assessment tool designed by our research team. The tool measures 11 documentation components of the outpatient note. Each of the 11 components are scaled either 0-1 or 0-4 based on perceived importance by our physician designers.
Measured: immediately after intervention and 30+ days in follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2010 (estimated)
- Study startJul 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiseaseStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uniformed Services University of the Health Sciences
- Sponsor type
- US federal agency
- Investigators
- Mark B. Stephens, MD, MS, Study director, Uniformed Services University of the Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01043133
- Sponsor's protocol ID
- B02930
- Status last verified
- Jan 2010
- First submitted
- 5 Jan 2010
- Last updated
- 12 Aug 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Marketing in Medical Education: Influencing Medical Student Use of Evidence-based Templates in Outpatient Documentation of Asthma Care Using an Electronic Medical Record
- ClinicalTrials.gov ID
- NCT01043133
- Acronym / sponsor ID
- B02930
- Conditions
- Disease
- Keywords
- electronic medical records, documentation templates, clinical encounter notes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Uniformed Services University of the Health SciencesUS federal agency
- Study start
- Jul 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 6 Jan 2010 (estimated)
- Results
- Posted 12 Aug 2011
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 the study is to measure the effectiveness of a social marketing-based medical education intervention on student use of evidence-based templates for documenting outpatient asthma care within an electronic medical record.
Detailed description
The purpose of the study was to measure the effectiveness of a physician-educator led clinical documentation workshop, embedded with 7 persuasive social-marketing based messages, on medical student response using a targeted asthma template. Stated differently, whether a physician-educator could "persuade" medical students to use an evidence-based EMR asthma template to document an outpatient mild persistent asthma encounter with a patient.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: social marketing-based medical education intervention |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Third year medical student completing family medicine clerkship Uniformed Services University
Key exclusion criteria (1 listed)
- All students other than those listed above
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 |
|---|---|---|
| social marketing-based medical education interventionAlso: persuasionsocial-marketing based medical education intervention designed to influence medical student use of evidence-based templates. Led by physician instructor. | Behavioural | Intervention group |
Primary outcome
Number of Participants Using Evidence-based Template to Document Asthma Care Within an Electronic Medical Record
Time frame: immediately after invervention and 30+ days in follow-up
The primary outcome measure is a count of whether or not the research participant uses the electronic health record-based Asthma AIM form to document a simulated outpatient mild persistent asthma encounter at T1 (immediately following intervention) and T2 (upon completion of family medicine clerkship approximately 35 days later).
1 secondary outcome
Clinical Note Completeness Score
Time frame: immediately after intervention and 30+ days in follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Mark B. Stephens, MD, MS study director
Uniformed Services University of the Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing social marketing-based medical education intervention in people with Disease, run by Uniformed Services University of the Health Sciences.
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 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 12 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Using Evidence-based Template to Document Asthma Care Within an Electronic Medical Record (time frame: immediately after invervention and 30+ days in follow-up). 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 12 Aug 2011.