Anterior Cervical Discectomy and Fusion
Conditions
Keywords
Augmented Reality, Preoperative Counseling, Patient Education
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.
Interventions
OTHERAugmented Reality Enhanced Preoperative Counseling
For patients undergoing AR enhanced preoperative counseling, headset-based AR holograms of standardized patient anatomy through AnatomyX as well as patient specific anatomy through SurgicalAR will be projected to assist the surgeon in educating the patient throughout preoperative counseling.
Control patients will undergo standard preoperative counseling.
Sponsors
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient surgery satisfaction level 6 months post-operatively | Patient surgery satisfaction will be assessed approximately 6 months post-operatively | A visual analog scales ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied |
| Patient postoperative visit satisfaction level 6 months post-operatively | Patient postoperative visit satisfaction will be assessed approximately 6 months post-operatively | A visual analog scales ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied |
| Patient surgery satisfaction level 2 weeks post-operatively | Patient surgery satisfaction will be assessed approximately 2 weeks post-operatively | A visual analog scales ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied |
| Patient surgery visit satisfaction level 3 months post-operatively | Patient surgery satisfaction will be assessed approximately 3 months post-operatively | A visual analog scales ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied |
| Participant's past surgeries | This will be completed within 24 hours after enrollment | A list of the surgeries the patient has had in the past will be recorded |
| Names of pain medications | This will be completed within 24 hours after enrollment | The name of each pain medication a patient is taking at the time of the intervention will be recorded |
| Doses of pain medications | This will be completed within 24 hours after enrollment | The dose of each pain medication a patient is taking at the time of the intervention will be recorded |
| Amsterdam Preoperative Anxiety and Information Score (APAIS) survey after preoperative counseling | The APAIS is to be completed within 24 hours after preoperative counseling | The APAIS is a a preoperative anxiety score with 6 domains. The anxiety score ranges from 4 to 20 and encompasses anxiety for the surgery and the anesthesia. Higher scores represent greater levels of anxiety. |
| Amsterdam Preoperative Anxiety and Information Score (APAIS) survey | The APAIS is to be completed preoperatively on the day of the surgery | The APAIS is a a preoperative anxiety score with 6 domains. The anxiety score ranges from 4 to 20 and encompasses anxiety for the surgery and the anesthesia. Higher scores represent greater levels of anxiety. |
| Simulator Sickness Questionnaire (SSQ) | The SSQ will be completed within 24 hours after preoperative counseling in patients undergoing AR enhanced patient preoperative counseling | The SSQ is used to quantify simulator sickness within individuals during or following the use of extended reality environments across 3 domains. The total score ranges from 0-235.62 with higher scores representing higher sickness. |
| Evaluation of the Experience of General Anesthesia (EVAN-G) Survey | The EVAN-G will be completed within 24 hours after surgery | The EVAN-G is a patient satisfaction score with 6 domains. The score ranges from 0-100 with higher scores representing higher satisfaction. |
| Time of preoperative patient counseling | Assessed during preoperative patient counseling session | The total time it takes for a surgeon to perform preoperative patient counseling will be recorded. |
| Degree of knowledge acquisition questionnaire at baseline | Knowledge acquisition will be completed within 24 hours after preoperative counseling | Degree of knowledge acquisition will be determined by a qualitative post-counseling questionnaire and a short quiz asking patients about the anatomy involved in their surgery, how their pathology causes their symptoms, the steps of the surgery, and expected complications. The qualitative questionnaire will be recorded, transcribed, and coded using grounded theory to assess patient knowledge. The quiz score ranges from 0-20 with higher scores representing higher satisfaction. |
| Degree of knowledge acquisition questionnaire preoperatively | Knowledge acquisition will be completed preoperatively on the the day of surgery | Degree of knowledge acquisition will be determined by a qualitative post-counseling questionnaire and a short quiz asking patients about the anatomy involved in their surgery, how their pathology causes their symptoms, the steps of the surgery, and expected complications. The qualitative questionnaire will be recorded, transcribed, and coded using grounded theory to assess patient knowledge. The quiz score ranges from 0-20 with higher scores representing higher satisfaction. |
| Degree of knowledge acquisition questionnaire 2 weeks post-operative | Knowledge acquisition will be completed approximately 2 weeks post-operatively | Degree of knowledge acquisition will be determined by a qualitative post-counseling questionnaire and a short quiz asking patients about the anatomy involved in their surgery, how their pathology causes their symptoms, the steps of the surgery, and expected complications. The qualitative questionnaire will be recorded, transcribed, and coded using grounded theory to assess patient knowledge. The quiz score ranges from 0-20 with higher scores representing higher satisfaction. |
| Degree of knowledge acquisition questionnaire 3 months post-operative | Knowledge acquisition will be completed approximately 3 months post-operatively | Degree of knowledge acquisition will be determined by a qualitative post-counseling questionnaire and a short quiz asking patients about the anatomy involved in their surgery, how their pathology causes their symptoms, the steps of the surgery, and expected complications. The qualitative questionnaire will be recorded, transcribed, and coded using grounded theory to assess patient knowledge. The quiz score ranges from 0-20 with higher scores representing higher satisfaction. |
| Degree of knowledge acquisition questionnaire 6 months post-operative | Knowledge acquisition will be completed approximately 6 months post-operatively | Degree of knowledge acquisition will be determined by a qualitative post-counseling questionnaire and a short quiz asking patients about the anatomy involved in their surgery, how their pathology causes their symptoms, the steps of the surgery, and expected complications. The qualitative questionnaire will be recorded, transcribed, and coded using grounded theory to assess patient knowledge. The quiz score ranges from 0-20 with higher scores representing higher satisfaction. |
| Participant age | This will be documented within 24 hours after enrollment | The patients age at the time of the intervention will be recorded |
| Participant gender | This will be completed within 24 hours after enrollment | The patients gender will be recorded |
| Participant's indication for surgery | This will be completed within 24 hours after enrollment | The patients primary diagnosis that is the reason for surgery will be recorded |
| Participant education | This will be completed within 24 hours after enrollment | The patients number of years of formal education will be recorded |
| Prior experience with simulated environments | This will be completed prior to preoperative patient counseling within those individuals assigned to the AR enhanced preoperative counseling treatment arm | This will be assessed using a Likert 1-5 scale with 1 being no experience with extended reality environments and 5 being very experienced with extended reality environments |
| Patient understanding of surgery at baseline | Patient understanding will be assessed within 24 hours after preoperative counseling | A visual analog scale ranging from 1-10 with 1 being very unclear and 10 being very clear |
| Patient understanding of surgery preoperatively | Patient understanding will be assessed preoperatively on the the day of surgery | A visual analog scale ranging from 1-10 with 1 being very unclear and 10 being very clear |
| Patient understanding of surgery 2 weeks post-operative | Patient understanding will be assessed approximately 2 weeks post-operatively | A visual analog scale ranging from 1-10 with 1 being very unclear and 10 being very clear |
| Patient understanding of surgery 3 months post-operative | Patient understanding will be assessed approximately 3 months post-operatively | A visual analog scale ranging from 1-10 with 1 being very unclear and 10 being very clear |
| Patient understanding of surgery 6 months post-operative | Patient understanding will be assessed approximately 6 months post-operatively | A visual analog scale ranging from 1-10 with 1 being very unclear and 10 being very clear |
| Patient pain level expectation at baseline | Pain level expectation will be assessed within 24 hours after preoperative counseling | A visual analog scale ranging from 1-10 with 1 being no pain and 10 being worst pain of patients life. |
| Patient pain level expectation preoperatively | Pain level expectation will be assessed preoperatively on the the day of surgery | A visual analog scale ranging from 1-10 with 1 being no pain and 10 being worst pain of patients life. |
| Patient pain level 2 weeks post-operatively | Pain level will be assessed approximately 2 weeks post-operatively | A visual analog scale ranging from 1-10 with 1 being no pain and 10 being worst pain of patients life. |
| Patient pain level 3 months post-operatively | Pain level will be assessed approximately 3 months post-operatively | A visual analog scale ranging from 1-10 with 1 being no pain and 10 being worst pain of patients life. |
| Patient pain level 6 months post-operatively | Pain level will be assessed around 6 months post-operatively | A visual analog scale ranging from 1-10 with 1 being no pain and 10 being worst pain of patients life. |
| Confidence in surgeon at baseline | Confidence in surgeon will be assessed within 24 hours after preoperative counseling | A visual analog scale ranging from 1-10 with 1 being no confidence and 10 being total confidence |
| Confidence in surgeon preoperatively | Confidence in surgeon will be assessed preoperatively on the the day of surgery | A visual analog scale ranging from 1-10 with 1 being no confidence and 10 being total confidence |
| Confidence in surgeon 2 weeks post-operatively | Confidence in surgeon will be assessed approximately 2 weeks post-operatively | A visual analog scale ranging from 1-10 with 1 being no confidence and 10 being total confidence |
| Confidence in surgeon 3 months post-operatively | Confidence in surgeon will be assessed approximately 3 months post-operatively | A visual analog scale ranging from 1-10 with 1 being no confidence and 10 being total confidence |
| Confidence in surgeon 6 months post-operatively | Confidence in surgeon will be assessed approximately 6 months post-operatively | A visual analog scale ranging from 1-10 with 1 being no confidence and 10 being total confidence |
| Patient visit satisfaction level at baseline | Patient preoperative visit satisfaction will be assessed within 24 hours after preoperative counseling | A visual analog scale ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied |
| Patient visit satisfaction level preoperatively | Patient preoperative visit satisfaction will be assessed preoperatively on the the day of surgery | A visual analog scale ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied |
| Patient satisfaction level with the surgical explanation at baseline | Patient preoperative visit satisfaction will be assessed within 24 hours after preoperative counseling | A visual analog scale ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied |
| Patient satisfaction level with the surgical explanation preoperatively | Patient satisfaction with the surgical explanation will be assessed preoperatively on the the day of surgery | A visual analog scale ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied |
| Patient postoperative visit satisfaction level 2 weeks post-operatively | Patient postoperative visit satisfaction will be assessed approximately 2 weeks post-operatively | A visual analog scales ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied |
| Patient postoperative visit satisfaction level 3 months post-operatively | Patient postoperative visit satisfaction will be assessed approximately 3 months post-operatively | A visual analog scales ranging from 1-10 with 1 being no satisfaction and 10 being very satisfied |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient retention rates | Patient retention rates will be assessed up to 6 months post-operatively | Patient retention rates will be tracked for 6 months following surgical intervention |
| Patient preference on the type of preoperative counseling received for the AR-specific participants | This will be assessed immediately following preoperatiive counseling within the treatment group | Within the AR enhanced preoperative counseling treatment group, an additional preoperative variable collected will be if the patient found generic anatomy through AnatomyX, their own anatomy through SurgicalAR, or both the best method for AR counseling |
| Patient referral rates | Patient referral rates will be assessed up to 6 months post-operatively | Patient referral rates will be tracked for 6 months following surgical intervention |
Countries
United States
Outcome results
None listed