Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05495282 |
| Other study ID # |
IRB-21-1513 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 6, 2022 |
| Est. completion date |
March 2, 2023 |
Study information
| Verified date |
June 2023 |
| Source |
Carilion Clinic |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
