Trial Outcomes & Findings for Impact of Surgical Theater's Patient Engagement (NCT NCT05334212)

NCT ID: NCT05334212

Last Updated: 2023-02-13

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

7 participants

Primary outcome 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)

Results posted on

2023-02-13

Participant Flow

Participant milestones

Participant milestones
Measure
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.
Overall Study
STARTED
7
Overall Study
COMPLETED
0
Overall Study
NOT COMPLETED
7

Reasons for withdrawal

Reasons for withdrawal
Measure
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.
Overall Study
Study terminated prematurely
7

Baseline Characteristics

Impact of Surgical Theater's Patient Engagement

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Evaluation of Usefulness
n=7 Participants
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.
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
4 Participants
n=5 Participants
Age, Categorical
>=65 years
3 Participants
n=5 Participants
Sex: Female, Male
Female
6 Participants
n=5 Participants
Sex: Female, Male
Male
1 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
Race (NIH/OMB)
White
7 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants

PRIMARY outcome

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)

Population: Data not collected

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

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)

Population: Data not collected

0-10 Scale to assess how pain affects the ability to function across 15 categories. o 0 (optimal function) to 150 (total disability)

Outcome measures

Outcome data not reported

PRIMARY outcome

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)

Population: Data not collected

Understanding - before and after consult, Anxiety level - before and after consult, Satisfaction with consult, HCAHPS - Overall rating of hospital, Satisfied = 9 or 10 rating

Outcome measures

Outcome data not reported

Adverse Events

Evaluation of Usefulness

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Gabriel Smith

University Hospitals Cleveland Medical Center

Phone: (440)827-5088

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place