Educational ProblemsNCT05495282
Traditional Lecture Versus Procedural Video
A study testing Microvideo in people with Educational Problems, run by Carilion Clinic at 1 site in United States.
Trial summary
The study would consist of teaching pain management and physical medicine and rehabilitation physicians how to program and refill a baclofen pump with two different methods. A baclofen pump is a device that delivers a medication called baclofen to the spinal canal. Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Educational Problems
- What is being tested?
- Microvideo
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2022to 2 Mar 2023
- 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 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Board Certified or Board Eligible in Physical Medicine \& Rehabilitation or Pain Management
- A 25 to 70-year-old novice baclofen pump provider which is defined as refilling and programming less than ten baclofen pumps in simulation or clinical encounters in the past two years.
Who cannot join
- A experienced baclofen provider as defined refilling and programming more than ten baclofen pumps in simulation or clinical encounters in the past two years.
Trial locations and contacts
1 site in 1 country.
United States1 site
Carilion Roanoke Community Hospital
Roanoke, Virginia, 24013
About this study
Official title: Traditional Lecture Versus Procedural Video Randomized Trial: Comparative Analysis of Instructional Methods for Teaching Baclofen Pump Management
The study would consist of teaching pain management and physical medicine and rehabilitation physicians how to program and refill a baclofen pump with two different methods. A baclofen pump is a device that delivers a medication called baclofen to the spinal canal. The baclofen pump is surgically implanted near the abdomen, with a thin, flexible tube running to the spinal canal to deliver the medication. The study aims to measure the effectiveness of procedural video compared to traditional lectures in transferring skills for refilling and programming a baclofen pump. This will be a controlled study consisting of two randomly assigned groups of physicians with inexperience with refilling and programming baclofen pumps. Before randomization, all participants will be tested on baclofen pump refilling and programming on the baclofen pump simulator. The control group will then receive a traditional 60-minute lecture on teaching baclofen pump management, while the intervention group will watch a 10-minute video on baclofen pump management. The traditional lecture will consist of a PowerPoint lecture for 30 minutes, a demonstration of the refilling and programming technique for 10 minutes, and participant hands-on practice refilling and programming a baclofen pump for 20 minutes. The intervention group will have 30 minutes to view the video and practice hands-on baclofen pump refilling and programming. The video may be viewed as many times as needed over the 30 minutes. The participants will then be re-tested on baclofen pump refilling and programming on the simulator. Six to eight weeks later, the participants will have repeat testing on baclofen pump refilling and programming on the simulator to see if knowledge was retained over time. Once repeat testing is complete, the control group will review the 10-minute video, and the intervention group will receive the 60-minute traditional lecture. The study will conclude with an approximately 30-minute focus group discussing the two education methods.
Read the detailed description
Day 1 - 6 to 8 hours:
The study will be performed at Carilion Roanoke Community Hospital. Participants will be enrolled in a study to evaluate traditional lecture versus an asynchronous micro-video for teaching baclofen pump refilling and programming skills. Demographic information will be collected for each participant (table 1). Six education sessions will be conducted with ten participants per session. The duration of the session will be six to eight hours. All participants will perform pre-intervention baclofen pump refilling and programming in the simulated environment graded using a rubric for baclofen pump management. A SynchroMed II baclofen pump simulator will be used to simulate baclofen pump refilling and programming during the study. The participant will interrogate the pump, refill the pump with simulated intrathecal baclofen, and program the pump by increasing the daily rate of intrathecal baclofen by 10%. The scenarios used for the study will be the same for all simulations. Subjects will be tested individually to eliminate any group practice effects of observing other subjects testing. The rubric will be graded and recorded by one consistent investigator. The rubric has a minimum score of 0.5 and a maximum score of 10, with four steps referred to as "fatal flaws" that must be completed correctly to receive a passing score. A passing score on the rubric is a 9/10 with no "fatal flaws." The rubric for baclofen pump management has been studied in physical medicine \& rehabilitation residents, and non-published data showed a mean evaluation score and experience refilling and programming baclofen pumps to be highly correlated (Pearson coefficient = 0.899, p-value = 0.0489). Cronbach's alpha was calculated and was 0.91 showing good internal consistency.
Participants will be randomly allocated to either the micro-video intervention group or the traditional lecture control group. Randomization would be done using the random number generator formula in Microsoft Excel. They would be informed of their group allocation. The participants will not be blinded as they would come to know if they are placed in the intervention or the control group. Group A (n=30) will receive a baclofen pump refill and programming instruction via the traditional lecture method performed by a single faculty member. The traditional lecture will consist of a PowerPoint lecture for 30 minutes, a demonstration of the refilling and programming technique for 10 minutes, and participant hands-on practice refilling and programming a baclofen pump for 20 minutes. Group A will have time to practice refilling and programming baclofen pumps with the guidance of a single faculty member during the traditional 60-minute lecture. In contrast, Group B (n=30) will receive an asynchronous 10-minute micro-video on the topic for which no face-to-face interaction with faculty will be conducted. The micro-video will be provided on a 12.9-inch iPad pro for each participant to view individually. The micro-video group will also have the opportunity to practice pump refilling before the post-evaluation. Participants in Group B will have the micro-video instruction available while practicing hands-on baclofen pump refilling and programming. The maximum time allowed to view the micro-video and practice hands-on baclofen pump refilling and programming will be 30-minutes. The time that each participant in group B spends reviewing the micro-video and practicing hands-on pump refilling and programming will be recorded. The participant may view and rewind the video as many times as needed in the 30-minute period. The live demonstration and the procedural video describe identical steps involved in refilling and programming the baclofen pump.
The participants from both groups will then be subjected to post-intervention baclofen pump refilling and programming graded with the same rubric following exposure to the traditional lecture or asynchronous micro-video. The investigator that provided initial pre-intervention baclofen pump rubric grading will assess baclofen refilling and programming for both groups according to pre-specified criteria in the rubric. The investigator providing evaluation will be blinded to the instructional method. Subjects will be tested individually to eliminate any group practice effects of observing other subjects while testing. Rubric scoring will be recorded for both groups.
Day 2 - 4 to 5 hour:
Between six and eight weeks after the initial intervention, participants from both groups will perform a second post-intervention baclofen pump refilling and programming on a simulated patient with the same blinded investigator during six sessions of ten subjects each. This session will occur at Carilion Roanoke Community Hospital and will last four to five hours. Participants will be graded with the same rubric to see if knowledge was retained. Rubric scoring will be recorded for both groups. Subjects will be tested individually to eliminate any group practice effects of observing other subjects while testing. A traditional 60-minute lecture for Group B will follow the second post-intervention baclofen pump refilling and programming, and the asynchronous micro-video will be shared with Group A.
Following exposure to both methods of instruction, participants will provide feedback on the learning methods using structured focus groups (figure 1). Six focus group sessions will be performed with the ten subjects in each education session. Each focus group will last about 30 minutes to minimize participants' fatigue. One of the study investigators will serve as a trained moderator will lead the qualitative, semi-structured group interview to assess their overall experiences with traditional lecture versus an asynchronous micro-video (Appendix B). This will include new information learned by participants during the study, including discussing participant learning preferences that may inform future education practice for filling and programming baclofen pumps. The focus groups will be recorded and transcribed verbatim.
- Conditions
- Educational Problems
- Being tested
- Microvideo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicrovideoOther
Asynchronous 10-minute micro-video on the topic for which no face-to-face interaction with faculty will be conducted.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Traditonal Lecture | No intervention | Group A (n=30) will receive a baclofen pump refill and programming instruction via the traditional lecture method performed by a single faculty member. The traditional lecture will consist of a PowerPoint lecture for 30 minutes, a demonstration of the refilling and programming technique for 10 minutes, and participant hands-on practice refilling and programming a baclofen pump for 20 minutes. Group A will have time to practice refilling and programming baclofen pumps with the guidance of a single faculty member during the traditional 60-minute lecture. |
| Group B: Microvideo | Experimental | Group B (n=30) will receive an asynchronous 10-minute micro-video on the topic for which no face-to-face interaction with faculty will be conducted. The micro-video will be provided on a 12.9-inch iPad pro for each participant to view individually. The micro-video group will also have the opportunity to practice pump refilling before the post-evaluation. Participants in Group B will have the micro-video instruction available while practicing hands-on baclofen pump refilling and programming. The maximum time allowed to view the micro-video and practice hands-on baclofen pump refilling and programming will be 30-minutes. The time that each participant in group B spends reviewing the micro-video and practicing hands-on pump refilling and programming will be recorded. The participant may view and rewind the video as many times as needed in the 30-minute period. The live demonstration and the procedural video describe identical steps involved in refilling and programming the baclofen pump. Receives: Other: Microvideo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rubric scores
The primary outcome of the proposed study is to measure the effectiveness of procedural micro-video compared to traditional lectures in transferring skills for refilling and programming a baclofen pump using the rubric for baclofen pump refilling and programming at three-time points (pre-intervention, post-intervention, and six to eight weeks following intervention).
Measured: 3 months
Secondary outcomes (1)
Perceived effectiveness of learning modality
The secondary learning outcome measures the learner's perceived effectiveness of procedural video compared with a traditional lecture using qualitative research methods.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start6 Aug 2022
- Primary completion2 Mar 2023
- Study completion2 Mar 2023
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 Educational ProblemsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single-center cross over design
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carilion Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Justin L Weppner, DO, Principal investigator, Carilion Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495282
- Sponsor's protocol ID
- IRB-21-1513
- Status last verified
- Jun 2023
- First submitted
- 5 Aug 2022
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weppner J, Conti A, Locklear TM, Mayer RS. Traditional Lecture Versus Procedural Video Randomized Trial: Comparative Analysis of Instructional Methods for Teaching Baclofen Pump Management. Am J Phys Med Rehabil. 2024 Jun 1;103(6):510-517. doi: 10.1097/PHM.0000000000002397. Epub 2023 Dec 21.
PubMed 38261785
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traditional Lecture Versus Procedural Video Randomized Trial: Comparative Analysis of Instructional Methods for Teaching Baclofen Pump Management
- ClinicalTrials.gov ID
- NCT05495282
- Acronym / sponsor ID
- IRB-21-1513
- Conditions
- Educational Problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Carilion ClinicUniversity, hospital or other
- Study start
- 6 Aug 2022 (actual)
- Primary completion
- 2 Mar 2023 (actual)
- Study completion
- 2 Mar 2023 (actual)
- First posted
- 10 Aug 2022 (actual)
- 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 study would consist of teaching pain management and physical medicine and rehabilitation physicians how to program and refill a baclofen pump with two different methods. A baclofen pump is a device that delivers a medication called baclofen to the spinal canal. The baclofen pump is surgically implanted near the abdomen, with a thin, flexible tube running to the spinal canal to deliver the medication. The study aims to measure the effectiveness of procedural video compared to traditional lectures in transferring skills for refilling and programming a baclofen pump. This will be a controlled study consisting of two randomly assigned groups of physicians with inexperience with refilling and programming baclofen pumps. Before randomization, all participants will be tested on baclofen pump refilling and programming on the baclofen pump simulator. The control group will then receive a traditional 60-minute lecture on teaching baclofen pump management, while the intervention group will watch a 10-minute video on baclofen pump management. The traditional lecture will consist of a PowerPoint lecture for 30 minutes, a demonstration of the refilling and programming technique for 10 minutes, and participant hands-on practice refilling and programming a baclofen pump for 20 minutes. The intervention group will have 30 minutes to view the video and practice hands-on baclofen pump refilling and programming. The video may be viewed as many times as needed over the 30 minutes. The participants will then be re-tested on baclofen pump refilling and programming on the simulator. Six to eight weeks later, the participants will have repeat testing on baclofen pump refilling and programming on the simulator to see if knowledge was retained over time. Once repeat testing is complete, the control group will review the 10-minute video, and the intervention group will receive the 60-minute traditional lecture. The study will conclude with an approximately 30-minute focus group discussing the two education methods.
Detailed description
Day 1 - 6 to 8 hours:
The study will be performed at Carilion Roanoke Community Hospital. Participants will be enrolled in a study to evaluate traditional lecture versus an asynchronous micro-video for teaching baclofen pump refilling and programming skills. Demographic information will be collected for each participant (table 1). Six education sessions will be conducted with ten participants per session. The duration of the session will be six to eight hours. All participants will perform pre-intervention baclofen pump refilling and programming in the simulated environment graded using a rubric for baclofen pump management. A SynchroMed II baclofen pump simulator will be used to simulate baclofen pump refilling and programming during the study. The participant will interrogate the pump, refill the pump with simulated intrathecal baclofen, and program the pump by increasing the daily rate of intrathecal baclofen by 10%. The scenarios used for the study will be the same for all simulations. Subjects will be tested individually to eliminate any group practice effects of observing other subjects testing. The rubric will be graded and recorded by one consistent investigator. The rubric has a minimum score of 0.5 and a maximum score of 10, with four steps referred to as "fatal flaws" that must be completed correctly to receive a passing score. A passing score on the rubric is a 9/10 with no "fatal flaws." The rubric for baclofen pump management has been studied in physical medicine \& rehabilitation residents, and non-published data showed a mean evaluation score and experience refilling and programming baclofen pumps to be highly correlated (Pearson coefficient = 0.899, p-value = 0.0489). Cronbach's alpha was calculated and was 0.91 showing good internal consistency.
Participants will be randomly allocated to either the micro-video intervention group or the traditional lecture control group. Randomization would be done using the random number generator formula in Microsoft Excel. They would be informed of their group allocation. The participants will not be blinded as they would come to know if they are placed in the intervention or the control group. Group A (n=30) will receive a baclofen pump refill and programming instruction via the traditional lecture method performed by a single faculty member. The traditional lecture will consist of a PowerPoint lecture for 30 minutes, a demonstration of the refilling and programming technique for 10 minutes, and participant hands-on practice refilling and programming a baclofen pump for 20 minutes. Group A will have time to practice refilling and programming baclofen pumps with the guidance of a single faculty member during the traditional 60-minute lecture. In contrast, Group B (n=30) will receive an asynchronous 10-minute micro-video on the topic for which no face-to-face interaction with faculty will be conducted. The micro-video will be provided on a 12.9-inch iPad pro for each participant to view individually. The micro-video group will also have the opportunity to practice pump refilling before the post-evaluation. Participants in Group B will have the micro-video instruction available while practicing hands-on baclofen pump refilling and programming. The maximum time allowed to view the micro-video and practice hands-on baclofen pump refilling and programming will be 30-minutes. The time that each participant in group B spends reviewing the micro-video and practicing hands-on pump refilling and programming will be recorded. The participant may view and rewind the video as many times as needed in the 30-minute period. The live demonstration and the procedural video describe identical steps involved in refilling and programming the baclofen pump.
The participants from both groups will then be subjected to post-intervention baclofen pump refilling and programming graded with the same rubric following exposure to the traditional lecture or asynchronous micro-video. The investigator that provided initial pre-intervention baclofen pump rubric grading will assess baclofen refilling and programming for both groups according to pre-specified criteria in the rubric. The investigator providing evaluation will be blinded to the instructional method. Subjects will be tested individually to eliminate any group practice effects of observing other subjects while testing. Rubric scoring will be recorded for both groups.
Day 2 - 4 to 5 hour:
Between six and eight weeks after the initial intervention, participants from both groups will perform a second post-intervention baclofen pump refilling and programming on a simulated patient with the same blinded investigator during six sessions of ten subjects each. This session will occur at Carilion Roanoke Community Hospital and will last four to five hours. Participants will be graded with the same rubric to see if knowledge was retained. Rubric scoring will be recorded for both groups. Subjects will be tested individually to eliminate any group practice effects of observing other subjects while testing. A traditional 60-minute lecture for Group B will follow the second post-intervention baclofen pump refilling and programming, and the asynchronous micro-video will be shared with Group A.
Following exposure to both methods of instruction, participants will provide feedback on the learning methods using structured focus groups (figure 1). Six focus group sessions will be performed with the ten subjects in each education session. Each focus group will last about 30 minutes to minimize participants' fatigue. One of the study investigators will serve as a trained moderator will lead the qualitative, semi-structured group interview to assess their overall experiences with traditional lecture versus an asynchronous micro-video (Appendix B). This will include new information learned by participants during the study, including discussing participant learning preferences that may inform future education practice for filling and programming baclofen pumps. The focus groups will be recorded and transcribed verbatim.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single-center cross over design
| Arm | Type | Receives |
|---|---|---|
| Group A: Traditonal Lecture | No intervention | –Group A (n=30) will receive a baclofen pump refill and programming instruction via the traditional lecture method performed by a single faculty member. The traditional lecture will consist of a PowerPoint lecture for 30 minutes, a demonstration of the refilling and programming technique for 10 minutes, and participant hands-on practice refilling and programming a baclofen pump for 20 minutes. Group A will have time to practice refilling and programming baclofen pumps with the guidance of a single faculty member during the traditional 60-minute lecture. |
| Group B: Microvideo | Experimental | Other: MicrovideoGroup B (n=30) will receive an asynchronous 10-minute micro-video on the topic for which no face-to-face interaction with faculty will be conducted. The micro-video will be provided on a 12.9-inch iPad pro for each participant to view individually. The micro-video group will also have the opportunity to practice pump refilling before the post-evaluation. Participants in Group B will have the micro-video instruction available while practicing hands-on baclofen pump refilling and programming. The maximum time allowed to view the micro-video and practice hands-on baclofen pump refilling and programming will be 30-minutes. The time that each participant in group B spends reviewing the micro-video and practicing hands-on pump refilling and programming will be recorded. The participant may view and rewind the video as many times as needed in the 30-minute period. The live demonstration and the procedural video describe identical steps involved in refilling and programming the baclofen pump. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Board Certified or Board Eligible in Physical Medicine \& Rehabilitation or Pain Management
- A 25 to 70-year-old novice baclofen pump provider which is defined as refilling and programming less than ten baclofen pumps in simulation or clinical encounters in the past two years.
Key exclusion criteria (1 listed)
- A experienced baclofen provider as defined refilling and programming more than ten baclofen pumps in simulation or clinical encounters in the past two years.
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 |
|---|---|---|
| MicrovideoAsynchronous 10-minute micro-video on the topic for which no face-to-face interaction with faculty will be conducted. | Other | Group B: Microvideo |
Primary outcome
Rubric scores
Time frame: 3 months
The primary outcome of the proposed study is to measure the effectiveness of procedural micro-video compared to traditional lectures in transferring skills for refilling and programming a baclofen pump using the rubric for baclofen pump refilling and programming at three-time points (pre-intervention, post-intervention, and six to eight weeks following intervention).
1 secondary outcome
Perceived effectiveness of learning modality
Time frame: 3 months
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 23 Jun 2023.
- Derived from this study: PubMed 38261785Weppner J, Conti A, Locklear TM, Mayer RS. Traditional Lecture Versus Procedural Video Randomized Trial: Comparative Analysis of Instructional Methods for Teaching Baclofen Pump Management. Am J Phys Med Rehabil. 2024 Jun 1;103(6):510-517. doi: 10.1097/PHM.0000000000002397. Epub 2023 Dec 21.
- Individual participant dataSharing planned: No
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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.
Justin L Weppner, DO principal investigator
Carilion Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microvideo in people with Educational Problems, run by Carilion Clinic 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 2 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 23 Jun 2023. 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?
Rubric scores (time frame: 3 months). 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 NCT05495282, 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 23 Jun 2023.