Clinical trial NCT06340672: The Effect of AR in Patient Pre-operative Education
Official title: The Effect of Augmented Reality in Patient Pre-operative Education
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anterior Cervical Discectomy and Fusion
Keywords: Augmented Reality
Preoperative Counseling
Patient Education
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this clinical trial is to analyze the effect of augmented reality (AR) on patient education and overall satisfaction when used during preoperative counseling in adults undergoing spinal surgery. The main aims of this study are:

Aim 1: To determine if the use of AR in preoperative consultations is associated with higher levels of patient satisfaction, higher levels of confidence in surgeons, lower levels of preoperative anxiety, and lower patient reported pain scores.

Aim 2: To determine if the use of AR in preoperative consultation will enhance patient education and understanding during the surgical consent process and lead to higher patient retention rates and new patient referrals.

This study will compare AR enhanced preoperative patient counseling with conventional preoperative counseling practices.

Detailed description: This study will be performed on patients scheduled to undergo elective spinal surgery. The study will be a non-blinded, randomized clinical trial with a treatment arm and a control arm. After patient screening to determine eligibility and after patients are informed about the study and potential risks, all patients giving written informed consent will be randomized in a non-blinded manner in a 1:1 ratio to traditional preoperative patient counseling (control arm) or AR enhanced preoperative patient counseling (treatment arm). In the traditional preoperative patient counseling group, surgeons will explain the patients pathology and the surgery with only words and with or without pictures (MRI, CT, etc) and/or a generic 3D model. In the AR enhanced preoperative patient counseling group, the surgeon will have virtual, interactive models of the patients own anatomy projected through AR to show patients while describing the problem and how the surgery will be performed.

For all patients included within the treatment arm, the Medivis Surgical AR and AnatomyX platform will be deployed on the Microsoft Hololens 2 for AR image projection. When using Surgical AR, patient MRI and CT data will be accessed through the University of Pittsburgh Medical Centers Picture Archiving and Communication System (PACS) on the Medivis workstation. During preoperative consultation, the workstation will rapidly access the PACS system to pull the patients imaging and stream it to the Microsoft Hololens 2 AR-headset. For AnatomyX, a generic anatomic model is populated that can clearly present the anatomy involved in a procedure and also allows for a shared interactive space in which the patient, patient family, and surgeon can exist.

Eligibility criteria: Inclusion Criteria:

* 18-80 years-of-age
* Undergoing elective anterior cervical discectomy and fusion (ACDF)

Exclusion Criteria:

* Prior surgery
* Vestibular dysfunction
* Cannot tolerate AR immersion secondary to physical or psychiatric impairments
* Cognitive impairment
* Emergency procedures

Primary outcomes:
measure: Amsterdam Preoperative Anxiety and Information Score (APAIS) survey after preoperative counseling
timeFrame: The APAIS is to be completed within 24 hours after preoperative counseling
measure: Amsterdam Preoperative Anxiety and Information Score (APAIS) survey
timeFrame: The APAIS is to be completed preoperatively on the day of the surgery
measure: Simulator Sickness Questionnaire (SSQ)
timeFrame: The SSQ will be completed within 24 hours after preoperative counseling in patients undergoing AR enhanced patient preoperative counseling
measure: Evaluation of the Experience of General Anesthesia (EVAN-G) Survey
timeFrame: The EVAN-G will be completed within 24 hours after surgery
measure: Time of preoperative patient counseling
timeFrame: Assessed during preoperative patient counseling session
measure: Degree of knowledge acquisition questionnaire at baseline
timeFrame: Knowledge acquisition will be completed within 24 hours after preoperative counseling
measure: Degree of knowledge acquisition questionnaire preoperatively
timeFrame: Knowledge acquisition will be completed preoperatively on the the day of surgery
measure: Degree of knowledge acquisition questionnaire 2 weeks post-operative
timeFrame: Knowledge acquisition will be completed approximately 2 weeks post-operatively
measure: Degree of knowledge acquisition questionnaire 3 months post-operative
timeFrame: Knowledge acquisition will be completed approximately 3 months post-operatively
measure: Degree of knowledge acquisition questionnaire 6 months post-operative
timeFrame: Knowledge acquisition will be completed approximately 6 months post-operatively
measure: Participant age
timeFrame: This will be documented within 24 hours after enrollment
measure: Participant gender
timeFrame: This will be completed within 24 hours after enrollment
measure: Participant's indication for surgery
timeFrame: This will be completed within 24 hours after enrollment
measure: Participant education
timeFrame: This will be completed within 24 hours after enrollment
measure: Participant's past surgeries
timeFrame: This will be completed within 24 hours after enrollment
measure: Names of pain medications
timeFrame: This will be completed within 24 hours after enrollment
measure: Doses of pain medications
timeFrame: This will be completed within 24 hours after enrollment
measure: Prior experience with simulated environments
timeFrame: This will be completed prior to preoperative patient counseling within those individuals assigned to the AR enhanced preoperative counseling treatment arm
measure: Patient understanding of surgery at baseline
timeFrame: Patient understanding will be assessed within 24 hours after preoperative counseling
measure: Patient understanding of surgery preoperatively
timeFrame: Patient understanding will be assessed preoperatively on the the day of surgery
measure: Patient understanding of surgery 2 weeks post-operative
timeFrame: Patient understanding will be assessed approximately 2 weeks post-operatively
measure: Patient understanding of surgery 3 months post-operative
timeFrame: Patient understanding will be assessed approximately 3 months post-operatively
measure: Patient understanding of surgery 6 months post-operative
timeFrame: Patient understanding will be assessed approximately 6 months post-operatively
measure: Patient pain level expectation at baseline
timeFrame: Pain level expectation will be assessed within 24 hours after preoperative counseling
measure: Patient pain level expectation preoperatively
timeFrame: Pain level expectation will be assessed preoperatively on the the day of surgery
measure: Patient pain level 2 weeks post-operatively
timeFrame: Pain level will be assessed approximately 2 weeks post-operatively
measure: Patient pain level 3 months post-operatively
timeFrame: Pain level will be assessed approximately 3 months post-operatively
measure: Patient pain level 6 months post-operatively
timeFrame: Pain level will be assessed around 6 months post-operatively
measure: Confidence in surgeon at baseline
timeFrame: Confidence in surgeon will be assessed within 24 hours after preoperative counseling
measure: Confidence in surgeon preoperatively
timeFrame: Confidence in surgeon will be assessed preoperatively on the the day of surgery
measure: Confidence in surgeon 2 weeks post-operatively
timeFrame: Confidence in surgeon will be assessed approximately 2 weeks post-operatively
measure: Confidence in surgeon 3 months post-operatively
timeFrame: Confidence in surgeon will be assessed approximately 3 months post-operatively
measure: Confidence in surgeon 6 months post-operatively
timeFrame: Confidence in surgeon will be assessed approximately 6 months post-operatively
measure: Patient visit satisfaction level at baseline
timeFrame: Patient preoperative visit satisfaction will be assessed within 24 hours after preoperative counseling
measure: Patient visit satisfaction level preoperatively
timeFrame: Patient preoperative visit satisfaction will be assessed preoperatively on the the day of surgery
measure: Patient satisfaction level with the surgical explanation at baseline
timeFrame: Patient preoperative visit satisfaction will be assessed within 24 hours after preoperative counseling
measure: Patient satisfaction level with the surgical explanation preoperatively
timeFrame: Patient satisfaction with the surgical explanation will be assessed preoperatively on the the day of surgery
measure: Patient postoperative visit satisfaction level 2 weeks post-operatively
timeFrame: Patient postoperative visit satisfaction will be assessed approximately 2 weeks post-operatively
measure: Patient postoperative visit satisfaction level 3 months post-operatively
timeFrame: Patient postoperative visit satisfaction will be assessed approximately 3 months post-operatively
measure: Patient postoperative visit satisfaction level 6 months post-operatively
timeFrame: Patient postoperative visit satisfaction will be assessed approximately 6 months post-operatively
measure: Patient surgery satisfaction level 2 weeks post-operatively
timeFrame: Patient surgery satisfaction will be assessed approximately 2 weeks post-operatively
measure: Patient surgery visit satisfaction level 3 months post-operatively
timeFrame: Patient surgery satisfaction will be assessed approximately 3 months post-operatively
measure: Patient surgery satisfaction level 6 months post-operatively
timeFrame: Patient surgery satisfaction will be assessed approximately 6 months post-operatively
Secondary outcomes:
measure: Patient referral rates
timeFrame: Patient referral rates will be assessed up to 6 months post-operatively
measure: Patient retention rates
timeFrame: Patient retention rates will be assessed up to 6 months post-operatively
measure: Patient preference on the type of preoperative counseling received for the AR-specific participants
timeFrame: This will be assessed immediately following preoperatiive counseling within the treatment group
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh Medical Center
name: Edward Andrews, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bekelis K, Calnan D, Simmons N, MacKenzie TA, Kakoulides G. Effect of an Immersive Preoperative Virtual Reality Experience on Patient Reported Outcomes: A Randomized Controlled Trial. Ann Surg. 2017 Jun;265(6):1068-1073. doi: 10.1097/SLA.0000000000002094.
citation: Collins MK, Ding VY, Ball RL, Dolce DL, Henderson JM, Halpern CH. Novel application of virtual reality in patient engagement for deep brain stimulation: A pilot study. Brain Stimul. 2018 Jul-Aug;11(4):935-937. doi: 10.1016/j.brs.2018.03.012. Epub 2018 Mar 15. No abstract available.
citation: Eastwood D, Manson N, Bigney E, Darling M, Richardson E, Paixao R, Underwood T, Ellis K, Abraham E. Improving postoperative patient reported benefits and satisfaction following spinal fusion with a single preoperative education session. Spine J. 2019 May;19(5):840-845. doi: 10.1016/j.spinee.2018.11.010. Epub 2018 Nov 22.
citation: Panesar SS, Magnetta M, Mukherjee D, Abhinav K, Branstetter BF, Gardner PA, Iv M, Fernandez-Miranda JC. Patient-specific 3-dimensionally printed models for neurosurgical planning and education. Neurosurg Focus. 2019 Dec 1;47(6):E12. doi: 10.3171/2019.9.FOCUS19511.
citation: Rampersaud YR, Canizares M, Perruccio AV, Abraham E, Bailey CS, Christie SD, Evaniew N, Finkelstein JA, Glennie RA, Johnson MG, Nataraj A, Paquet J, Phan P, Weber MH, Thomas K, Manson N, Hall H, Fisher CG. Fulfillment of Patient Expectations After Spine Surgery is Critical to Patient Satisfaction: A Cohort Study of Spine Surgery Patients. Neurosurgery. 2022 Jul 1;91(1):173-181. doi: 10.1227/neu.0000000000001981. Epub 2022 Apr 22.
citation: Sezer S, Piai V, Kessels RPC, Ter Laan M. Information Recall in Pre-Operative Consultation for Glioma Surgery Using Actual Size Three-Dimensional Models. J Clin Med. 2020 Nov 13;9(11):3660. doi: 10.3390/jcm9113660.
citation: Zhuang YD, Zhou MC, Liu SC, Wu JF, Wang R, Chen CM. Effectiveness of personalized 3D printed models for patient education in degenerative lumbar disease. Patient Educ Couns. 2019 Oct;102(10):1875-1881. doi: 10.1016/j.pec.2019.05.006. Epub 2019 May 8.
citation: Delgado CA, McCullers MR, Bloom SW. Evaluating the Efficacy of Surgical Consent. Am Surg. 2023 Aug;89(8):3433-3437. doi: 10.1177/00031348231161702. Epub 2023 Mar 15.