TerminatedNot Applicable

Impact of Surgical Theater's Patient Engagement

Stopped: Lack of support/funding

United States7 participantsStarted 2022-01-01

Plain-language 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.

Who can participate

Age range

18 Years – 89 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age range: 18-89.
. Patients undergoing elective lumbar or cervical spine surgeries
. Those who are receiving Surgical Theater consultation as part of their clinical care

Exclusion criteria

. Age \<18 years
. Non-elective surgery due to emergency, trauma
. Patients undergoing correction for spinal deformities

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change From Baseline EQ-5D Health-Related Quality of Life at 6 Months After Surgery

Timeframe: 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)

Change From Baseline Pain Disability Questionnaire (PDQ) at 6 Months After Surgery

Timeframe: 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)

Change in Patient Satisfaction and Understanding With HCHAPS (Hospital Consumer Assessment of Healthcare Providers and Systems) at 6 Months After Surgery

Timeframe: 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)

Trial details

NCT IDNCT05334212

SponsorUniversity Hospitals Cleveland Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-02-02

Results submitted2022-12-05

View on ClinicalTrials.gov More Lumbar Spine Surgeries trials

Who can participate

Age range

18 Years – 89 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age range: 18-89.
. Patients undergoing elective lumbar or cervical spine surgeries
. Those who are receiving Surgical Theater consultation as part of their clinical care

Exclusion criteria

. Age \<18 years
. Non-elective surgery due to emergency, trauma
. Patients undergoing correction for spinal deformities

What they're measuring

Change From Baseline EQ-5D Health-Related Quality of Life at 6 Months After Surgery

Timeframe: 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)

Change From Baseline Pain Disability Questionnaire (PDQ) at 6 Months After Surgery

Timeframe: 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)

Change in Patient Satisfaction and Understanding With HCHAPS (Hospital Consumer Assessment of Healthcare Providers and Systems) at 6 Months After Surgery

Timeframe: 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)