Heart MurmurNCT01596465
Study of Two Teaching Techniques to Teach Cardiac Auscultation to Physicians
A study testing Self-Study using MP3 Player and Multimedia Lecture in people with Heart Murmur, run by The Reading Hospital and Medical Center at 1 site in United States.
Trial summary
Our objective was to test two educational interventions for teaching cardiac auscultation: self-directed learning using portable audio files versus a single, massed multimedia lecture intervention similar to current best practice, to determine which would most effectively increase recognition of common cardiac sounds… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Heart Murmur
- What is being tested?
- Self-Study using MP3 Player and Multimedia Lecture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to 9 Oct 2012
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All non-cardiologist physicians from one institution were eligible for the study. Participants were 83 non-cardiologist physician volunteers (57 practicing physicians, 26 residents in training) from one Academic Independent Medical Center in the Northeastern United States enrolled between January 11, 2011 and February 25, 2011.
Who cannot join
- Cardiologists,
- Non-physicians.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Reading Hospital and Medical Center
West Reading, Pennsylvania, 19612
About this study
Official title: Self-Directed Study Using MP3 Players Versus Multimedia Lecture to Improve Auscultation Proficiency of Physicians: A Randomized, Controlled Trial.
Our objective was to test two educational interventions for teaching cardiac auscultation: self-directed learning using portable audio files versus a single, massed multimedia lecture intervention similar to current best practice, to determine which would most effectively increase recognition of common cardiac sounds by physicians. The investigators hypothesized that doctors learning on their own time could better improve their skills.
Read the detailed description
Participants All non-cardiologist physicians were eligible for the study and responded to recruitment advertising. Participants were 83 non-cardiologist physician volunteers (57 practicing physicians, 26 residents in training) from one Academic Independent Medical Center in the Northeastern United States enrolled between January 11, 2011 and February 25, 2011. Participants were randomized by study investigators using a table of random numbers. All participants were given an MP3 player at the time of enrollment for compensation of their time, but received no grade for participation. Participants provided their informed consent before enrolling in the study.
Educational Interventions Following the pretest, participants in the interventional arm of the study were given an MP3 player which contained eight, 15-second heart sound files (7 pathologic heart sound files and 1 normal heart sound file) alternated with nine leisure songs. MP3 players could play files in order or "shuffle" files in random order. Each heart sound file was introduced by the narrated phrase "Identify this sound,", followed by 10 beats of a heart sound recording, then the narrated identification of the heart sound. Participants were asked to use the MP3 player in order to improve their auscultation skills as often as they could and asked to record their activities while listening, but were given no further training.
Following the pretest, participants in the control arm received a 1-hour multimedia lecture (Power Point) taught by the same faculty member (AGK), which reviewed the pathophysiology, exacerbating and relieving factors, as well as visual diagrams of the heart sounds. The normal and seven pathologic heart sounds were played for participants during the lecture for a total of 2 minutes through high-quality home stereo speakers, exposing learners to 1280 beats in the 1-hour session. Abnormal sounds were taught in groups of systolic, diastolic and extra sounds, and were first introduced by name, and then as unknowns using mixed practice in each of the three sections. At the end of the session, control group participants were given an MP3 player with no heart sound files as honoraria. Both the intervention and control group were told they would be retested at 12 weeks. Both were given a paper copy of the Power Point slides for self-study, but had no electronic access to the original slides. Both groups were asked not to discuss the study with the other participants.
Content of the audio files The audio files of the heart sounds were obtained from actual patients and have validity evidence generated in prior studies. The pathologic sounds included aortic stenosis, aortic insufficiency, mitral stenosis, mitral insufficiency, mitral valve prolapse, S3, S4, and the normal heart sound. These heart sounds collectively represent the most important auscultatory findings according to a previously published national survey of residency program directors.
Measurement All participants took a 15-question pretest in addition to a posttest at 12 weeks using identical heart sound files to those used in training. Tests consisted of 8-second clips of each heart sound file, with 10 beats of each sound. Participants were given 15 seconds after each question to choose the correct response from an extended match list that included 9 choices, one of which was not represented among the training materials ("benign flow murmur"). Each of the 7 pathologic heart sounds were represented twice, with normal heart sounds represented once. The order of questions for the test was randomly selected. The same speakers used in the lecture format were also employed utilized for testing. Study examiners tested the speaker sound quality before each test. All tests were independently hand-graded by two graders, and all discrepancies in handwriting and scoring were resolved by consensus of both investigators. Grades were not shared with participants.
Both groups were asked to rate their prior experience with pathologic heart sounds, including observation and feedback they have received, satisfaction with the teaching modality and confidence in their auscultatory skill at the pretest and posttesting. Both groups audited their preference for learning style by the VARK© learning style assessment instrument Version 7.0, at the time of enrollment. Both groups were asked to record any other methods used to study auscultation during the study period. Intervention group exposure to heart sounds was determined by electronic interrogation of their MP3 player at 12 weeks. Play counts recorded by the device were reviewed by both study investigators and entered on an electronic spreadsheet.
Data analysis Demographic comparisons, Likert scales of satisfaction and pathologic heart sound exposure between control and intervention groups were performed via Chi-square testing and Student's t-test as appropriate. Internal consistency of the pretest was performed using Cronbach's alpha. Total study time was recorded as 60 minutes for the control group, and was calculated by the total number of recorded plays multiplied by 15 seconds per play for the intervention group. Additional self-reported study methods and amount of exposure were recorded but not added to control and intervention study time calculations. The primary outcome was the difference in test score from pretest to posttest and was compared using paired t-tests. Effect sizes for both arms were computed using differences in means divided by pooled standard deviations. Correlations between exposure and improvement from pretest to posttest in the intervention group were calculated by linear regression. Subgroup analysis of intervention group participants who did not use their MP3 player between weeks 4 and 12 (defined as play count= 0 during time interval) was performed to approximate decay in that group, and was analyzed by paired t-test. The auditory learning preference of the VARK learning style inventory was characterized dichotomously as present or absent. A two-factor ANOVA was performed comparing intervention and control groups with presence of auditory learning style against the primary outcome as the dependent variable to determine the relative effects of learning style and instructional method. Power calculations were made for the observed differences between the control and intervention arms for both variables of the primary objectives.
- Conditions
- Heart Murmur
- Being tested
- Self-Study using MP3 Player, Multimedia Lecture
- Medical subject headings
- Heart Murmurs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Study using MP3 PlayerOther
Also called Self-Study
Participants in the interventional arm of the study were given an MP3 player which contained eight, 15-second heart sound files (7 pathologic heart sound files and 1 normal heart sound file) alternated with nine leisure songs. MP3 players could play files in order or "shuffle" files in random order. Each heart sound file was introduced by the narrated phrase "Identify this sound,", followed by 10 beats of a heart sound recording, then the narrated identification of the heart sound. Participants were asked to use the MP3 player in order to improve their auscultation skills as often as they could and asked to record their activities while listening, but were given no further training.
Multimedia LectureOther
Also called Lecture
Following the pretest, participants in the control arm received a 1-hour multimedia lecture (Power Point) taught by the same faculty member (AGK), which reviewed the pathophysiology, exacerbating and relieving factors, as well as visual diagrams of the heart sounds. The normal and seven pathologic heart sounds were played for participants during the lecture for a total of 2 minutes through high-quality home stereo speakers, exposing learners to 1280 beats in the 1-hour session. Abnormal sounds were taught in groups of systolic, diastolic and extra sounds, and were first introduced by name, and then as unknowns using mixed practice in each of the three sections.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Control arm Receives: Other: Multimedia Lecture |
| Intervention | Active comparator | Intervention arm Receives: Other: Self-Study using MP3 Player |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in auscultation score at 4 and 12 weeks
Primary outcome was an improvement in test score from pre-test to 4 and 12-week post-test. All participants took a 15-question pretest in addition to a posttest at 4 and 12 weeks using identical heart sound files to those used in training. Each test Tests consisted of 8-second clips of each heart sound file, with 10 beats of each sound.
Measured: 12 weeks
Secondary outcomes (2)
Learner Satisfaction
Both groups were asked to rate satisfaction with the teaching modality at the pretest and posttesting via 6-point Likert scale.
Measured: 12 weeks
Learner confidence
Both groups were asked to rate confidence in their auscultatory skill at the pretest and posttesting at 12 weeks on a 6-point Likert scale.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2012 (estimated)
- Study startJan 2011
- Primary completionJun 2011
- Study completion9 Oct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart MurmurStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Reading Hospital and Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony A. Donato, The Reading Hospital and Medical Center
- Investigators
- Anthony A Donato, MD, Study director, The Reading Hospital and Medical CenterAntony G Kaliyadan, MD, Principal investigator, The Reading Hospital and Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01596465
- Sponsor's protocol ID
- TRHMC-049-010
- Status last verified
- May 2021
- First submitted
- 8 May 2012
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Directed Study Using MP3 Players Versus Multimedia Lecture to Improve Auscultation Proficiency of Physicians: A Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT01596465
- Acronym / sponsor ID
- TRHMC-049-010
- Conditions
- Heart Murmur
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- The Reading Hospital and Medical CenterUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- 9 Oct 2012 (actual)
- First posted
- 11 May 2012 (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.
Our objective was to test two educational interventions for teaching cardiac auscultation: self-directed learning using portable audio files versus a single, massed multimedia lecture intervention similar to current best practice, to determine which would most effectively increase recognition of common cardiac sounds by physicians. The investigators hypothesized that doctors learning on their own time could better improve their skills.
Detailed description
Participants All non-cardiologist physicians were eligible for the study and responded to recruitment advertising. Participants were 83 non-cardiologist physician volunteers (57 practicing physicians, 26 residents in training) from one Academic Independent Medical Center in the Northeastern United States enrolled between January 11, 2011 and February 25, 2011. Participants were randomized by study investigators using a table of random numbers. All participants were given an MP3 player at the time of enrollment for compensation of their time, but received no grade for participation. Participants provided their informed consent before enrolling in the study.
Educational Interventions Following the pretest, participants in the interventional arm of the study were given an MP3 player which contained eight, 15-second heart sound files (7 pathologic heart sound files and 1 normal heart sound file) alternated with nine leisure songs. MP3 players could play files in order or "shuffle" files in random order. Each heart sound file was introduced by the narrated phrase "Identify this sound,", followed by 10 beats of a heart sound recording, then the narrated identification of the heart sound. Participants were asked to use the MP3 player in order to improve their auscultation skills as often as they could and asked to record their activities while listening, but were given no further training.
Following the pretest, participants in the control arm received a 1-hour multimedia lecture (Power Point) taught by the same faculty member (AGK), which reviewed the pathophysiology, exacerbating and relieving factors, as well as visual diagrams of the heart sounds. The normal and seven pathologic heart sounds were played for participants during the lecture for a total of 2 minutes through high-quality home stereo speakers, exposing learners to 1280 beats in the 1-hour session. Abnormal sounds were taught in groups of systolic, diastolic and extra sounds, and were first introduced by name, and then as unknowns using mixed practice in each of the three sections. At the end of the session, control group participants were given an MP3 player with no heart sound files as honoraria. Both the intervention and control group were told they would be retested at 12 weeks. Both were given a paper copy of the Power Point slides for self-study, but had no electronic access to the original slides. Both groups were asked not to discuss the study with the other participants.
Content of the audio files The audio files of the heart sounds were obtained from actual patients and have validity evidence generated in prior studies. The pathologic sounds included aortic stenosis, aortic insufficiency, mitral stenosis, mitral insufficiency, mitral valve prolapse, S3, S4, and the normal heart sound. These heart sounds collectively represent the most important auscultatory findings according to a previously published national survey of residency program directors.
Measurement All participants took a 15-question pretest in addition to a posttest at 12 weeks using identical heart sound files to those used in training. Tests consisted of 8-second clips of each heart sound file, with 10 beats of each sound. Participants were given 15 seconds after each question to choose the correct response from an extended match list that included 9 choices, one of which was not represented among the training materials ("benign flow murmur"). Each of the 7 pathologic heart sounds were represented twice, with normal heart sounds represented once. The order of questions for the test was randomly selected. The same speakers used in the lecture format were also employed utilized for testing. Study examiners tested the speaker sound quality before each test. All tests were independently hand-graded by two graders, and all discrepancies in handwriting and scoring were resolved by consensus of both investigators. Grades were not shared with participants.
Both groups were asked to rate their prior experience with pathologic heart sounds, including observation and feedback they have received, satisfaction with the teaching modality and confidence in their auscultatory skill at the pretest and posttesting. Both groups audited their preference for learning style by the VARK© learning style assessment instrument Version 7.0, at the time of enrollment. Both groups were asked to record any other methods used to study auscultation during the study period. Intervention group exposure to heart sounds was determined by electronic interrogation of their MP3 player at 12 weeks. Play counts recorded by the device were reviewed by both study investigators and entered on an electronic spreadsheet.
Data analysis Demographic comparisons, Likert scales of satisfaction and pathologic heart sound exposure between control and intervention groups were performed via Chi-square testing and Student's t-test as appropriate. Internal consistency of the pretest was performed using Cronbach's alpha. Total study time was recorded as 60 minutes for the control group, and was calculated by the total number of recorded plays multiplied by 15 seconds per play for the intervention group. Additional self-reported study methods and amount of exposure were recorded but not added to control and intervention study time calculations. The primary outcome was the difference in test score from pretest to posttest and was compared using paired t-tests. Effect sizes for both arms were computed using differences in means divided by pooled standard deviations. Correlations between exposure and improvement from pretest to posttest in the intervention group were calculated by linear regression. Subgroup analysis of intervention group participants who did not use their MP3 player between weeks 4 and 12 (defined as play count= 0 during time interval) was performed to approximate decay in that group, and was analyzed by paired t-test. The auditory learning preference of the VARK learning style inventory was characterized dichotomously as present or absent. A two-factor ANOVA was performed comparing intervention and control groups with presence of auditory learning style against the primary outcome as the dependent variable to determine the relative effects of learning style and instructional method. Power calculations were made for the observed differences between the control and intervention arms for both variables of the primary objectives.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Multimedia LectureControl arm |
| Intervention | Active comparator | Other: Self-Study using MP3 PlayerIntervention arm |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All non-cardiologist physicians from one institution were eligible for the study. Participants were 83 non-cardiologist physician volunteers (57 practicing physicians, 26 residents in training) from one Academic Independent Medical Center in the Northeastern United States enrolled between January 11, 2011 and February 25, 2011.
Key exclusion criteria (2 listed)
- Cardiologists,
- Non-physicians.
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 |
|---|---|---|
| Self-Study using MP3 PlayerAlso: Self-StudyParticipants in the interventional arm of the study were given an MP3 player which contained eight, 15-second heart sound files (7 pathologic heart sound files and 1 normal heart sound file) alternated with nine leisure songs. MP3 players could play files in order or "shuffle" files in random order. Each heart sound file was introduced by the narrated phrase "Identify this sound,", followed by 10 beats of a heart sound recording, then the narrated identification of the heart sound. Participants were asked to use the MP3 player in order to improve their auscultation skills as often as they could and asked to record their activities while listening, but were given no further training. | Other | Intervention |
| Multimedia LectureAlso: LectureFollowing the pretest, participants in the control arm received a 1-hour multimedia lecture (Power Point) taught by the same faculty member (AGK), which reviewed the pathophysiology, exacerbating and relieving factors, as well as visual diagrams of the heart sounds. The normal and seven pathologic heart sounds were played for participants during the lecture for a total of 2 minutes through high-quality home stereo speakers, exposing learners to 1280 beats in the 1-hour session. Abnormal sounds were taught in groups of systolic, diastolic and extra sounds, and were first introduced by name, and then as unknowns using mixed practice in each of the three sections. | Other | Control |
Primary outcome
Improvement in auscultation score at 4 and 12 weeks
Time frame: 12 weeks
Primary outcome was an improvement in test score from pre-test to 4 and 12-week post-test. All participants took a 15-question pretest in addition to a posttest at 4 and 12 weeks using identical heart sound files to those used in training. Each test Tests consisted of 8-second clips of each heart sound file, with 10 beats of each sound.
2 secondary outcomes
Learner Satisfaction
Time frame: 12 weeks
Learner confidence
Time frame: 12 weeks
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 2 Jun 2021.
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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.
Anthony A Donato, MD study director
The Reading Hospital and Medical Center
Antony G Kaliyadan, MD principal investigator
The Reading Hospital and Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Study using MP3 Player and Multimedia Lecture in people with Heart Murmur, run by The Reading Hospital and Medical Center 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 2 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 2 Jun 2021. 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?
Improvement in auscultation score at 4 and 12 weeks (time frame: 12 weeks). 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 2 Jun 2021.