Cervical Spine Surgeries, Lumbar Spine Surgeries
Conditions
Brief summary
To evaluate usefulness of Surgical Theater's Patient Engagement 360VR platform in helping align patient expectations and improve patient satisfaction and understanding in spinal surgery consults.
Detailed description
Surgical Theater is a company that has developed a platform which can be used to describe and explain spinal surgery to patient before they undergo the procedure. The platform specifically implements data from the patient's own MRI and CT scans, creating a 3d reconstruction that can be seen through a virtual reality lens. This technology was developed to help clarify any concerns patient's may have before surgery, and help them better appreciate what will occur in the OR. Surgical theater has FDA clearance for patient interaction and engagement. Our study is to take surgical theater into our clinics and, after a patient is defined as a surgical candidate, use surgical theater to provide spatial learning and comprehension through modeling so they better understand their surgical plan. Only the SRP system will be used for this study (Surgical Planner). The intervention is showing surgical theater to patients identified for surgery in clinic routinely. Surgical theater will be offered to all patients offered surgery. No other changes in practice will be done.
Interventions
DEVICESurgical Theater
The surgical theater platform uses data from MRI and CT scans, creating a 3d image that can be seen by the patient.
Sponsors
University Hospitals Cleveland Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
1. Age range: 18-89. 2. Patients undergoing elective lumbar or cervical spine surgeries 3. Those who are receiving Surgical Theater consultation as part of their clinical care
Exclusion criteria
1. Age \<18 years 2. Non-elective surgery due to emergency, trauma 3. Patients undergoing correction for spinal deformities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline EQ-5D Health-Related Quality of Life at 6 Months After Surgery | Visits 1, 2, 3, 4 - 1. Before 360VR consult (Visit 1) 2. Immediately after 360VR consult (Visit 1) 3. Post-op 6 weeks (Visit 2) 4. Post op 3 months (Visit 3) 5. Post op 6 month (Visit 4) | Reports on 5 dimensions of health: Mobility, Self-care, Usual activities, Pain/Discomfort, Anxiety/Depression. Each score from 1-3 with 1.0 being perfect health. |
| Change From Baseline Pain Disability Questionnaire (PDQ) at 6 Months After Surgery | Visits 1, 2, 3, 4 - 1. Before 360VR consult (Visit 1) 2. Immediately after 360VR consult (Visit 1) 3. Post-op 6 weeks (Visit 2) 4. Post op 3 months (Visit 3) 5. Post op 6 month (Visit 4) | 0-10 Scale to assess how pain affects the ability to function across 15 categories. o 0 (optimal function) to 150 (total disability) |
| Change in Patient Satisfaction and Understanding With HCHAPS (Hospital Consumer Assessment of Healthcare Providers and Systems) at 6 Months After Surgery | Visits 1, 2, 3, 4 - 1. Before 360VR consult (Visit 1) 2. Immediately after 360VR consult (Visit 1) 3. Post-op 6 weeks (Visit 2) 4. Post op 3 months (Visit 3) 5. Post op 6 month (Visit 4) | Understanding - before and after consult, Anxiety level - before and after consult, Satisfaction with consult, HCAHPS - Overall rating of hospital, Satisfied = 9 or 10 rating |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Evaluation of Usefulness To evaluate usefulness of Surgical Theater's Patient Engagement 360VR platform in helping align patient expectations and improve patient satisfaction and understanding in spinal surgery consults.
Surgical Theater: The surgical theater platform uses data from MRI and CT scans, creating a 3d image that can be seen by the patient. | 7 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Study terminated prematurely | 7 |
Baseline characteristics
| Characteristic | Evaluation of Usefulness |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 7 |
| other Total, other adverse events | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
Primary
Change From Baseline EQ-5D Health-Related Quality of Life at 6 Months After Surgery
Reports on 5 dimensions of health: Mobility, Self-care, Usual activities, Pain/Discomfort, Anxiety/Depression. Each score from 1-3 with 1.0 being perfect health.
Time frame: Visits 1, 2, 3, 4 - 1. Before 360VR consult (Visit 1) 2. Immediately after 360VR consult (Visit 1) 3. Post-op 6 weeks (Visit 2) 4. Post op 3 months (Visit 3) 5. Post op 6 month (Visit 4)
Population: Data not collected
Primary
Change From Baseline Pain Disability Questionnaire (PDQ) at 6 Months After Surgery
0-10 Scale to assess how pain affects the ability to function across 15 categories. o 0 (optimal function) to 150 (total disability)
Time frame: Visits 1, 2, 3, 4 - 1. Before 360VR consult (Visit 1) 2. Immediately after 360VR consult (Visit 1) 3. Post-op 6 weeks (Visit 2) 4. Post op 3 months (Visit 3) 5. Post op 6 month (Visit 4)
Population: Data not collected
Primary
Change in Patient Satisfaction and Understanding With HCHAPS (Hospital Consumer Assessment of Healthcare Providers and Systems) at 6 Months After Surgery
Understanding - before and after consult, Anxiety level - before and after consult, Satisfaction with consult, HCAHPS - Overall rating of hospital, Satisfied = 9 or 10 rating
Time frame: Visits 1, 2, 3, 4 - 1. Before 360VR consult (Visit 1) 2. Immediately after 360VR consult (Visit 1) 3. Post-op 6 weeks (Visit 2) 4. Post op 3 months (Visit 3) 5. Post op 6 month (Visit 4)
Population: Data not collected