Traditional Lecture Versus Procedural Video

NCT05495282 | Completed

• 1 other identifier: IRB-21-1513
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Educational Problems

Outcome Measures

Primary Outcomes (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).

  3 months

Secondary Outcomes (1)

• Perceived effectiveness of learning modality

  3 months

Study Arms (2)

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.

Other: Microvideo

Interventions

Microvideo OTHER

Asynchronous 10-minute micro-video on the topic for which no face-to-face interaction with faculty will be conducted.

Group B: Microvideo

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• A experienced baclofen provider as defined refilling and programming more than ten baclofen pumps in simulation or clinical encounters in the past two years.

Sponsors & Collaborators

• Carilion Clinic: lead

Study Sites (1)

Carilion Roanoke Community Hospital

Roanoke, Virginia, 24013, United States

Location

Related Publications (1)

• 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.

  PMID: 38261785 DERIVED

Study Officials

• Justin L Weppner, DO

  Carilion Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator and outcomes assessor will be masked
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center cross over design

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 10, 2022
• Study Start: August 6, 2022
• Primary Completion: March 2, 2023
• Study Completion: March 2, 2023
• Last Updated: June 23, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)