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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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.

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 groups in NCT05495282
Study groupRoleWhat they receive
Group A: Traditonal LectureNo interventionGroup 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: MicrovideoExperimentalGroup 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.

  1. 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)
  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.

  1. First posted10 Aug 2022
  2. Study start6 Aug 2022
  3. Primary completion2 Mar 2023
  4. Study completion2 Mar 2023

Resources

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)
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

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.

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