Traditional Lecture Versus Procedural Video
Condition: Educational Problems
Study type: Interventional

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. 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.
    

Intervention name(s): Microvideo
Intervention type(s): Other
Intervention description(s): Asynchronous 10-minute micro-video on the topic for which no face-to-face interaction with faculty will be conducted.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Single-center cross over design
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science