Pregnancy Related
Conditions
Keywords
Collaboration Live, Telemedicine, Ultrasound
Brief summary
Collaboration Live is a prospective, single-arm clinical study of subjects who provide written consent. Subjects are scanned using a Philips EPIQ 5 or EPIQ 7 Ultrasound System equipped with Collaboration Live software. The study investigator will evaluate performance of the Collaboration Live tool with regard to performance of conferencing, sharing and control capabilities. Adverse events will be reported and the study investigator will assess potential relationship to the study device or study procedure. Additionally, the utility of Collaboration Live in remote consult of study patients will be evaluated. No patient follow-up beyond the initial consultation will be conducted with the Collaboration Live software solution.
Interventions
DEVICENon-diagnostic software solution
Collaboration Live is a non-diagnostic software solution intended for use with Philips (Philips Ultrasound, 22100 Bothell Everett Highway, Bothell, Washington 98021) EPIQ and Affiniti Series Ultrasound Systems (software version 5.0.2) that allows users to communicate (by text, voice, screen share, webcam video and remote takeover) from an ultrasound system or workstation to a remote destination.
Sponsors
Philips Clinical & Medical Affairs Global
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subject is at least 18 years of age * Subject in indicated for a routine Obstetrics/Gynecology ultrasound examination at the site. * Subject is willing and capable of providing informed consent and participating in this study
Exclusion criteria
* A medical condition or co-morbidity that would be unduly affected by study participation, per investigator discretion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Clinically Acceptable Performance of Remote Control Functionality | Intra-procedural (1 day) | The system responds to the remote input as intended and without a delay interfering with the conduct of the exam. Additionally, a clinically acceptable exam would result in no adverse events related to the control feature |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Success Rates for Key Tasks in the Collaborative Exam | Intra-procedural (1 day) | Establishing the remote connection, establishing text chat, establishing voice call, establishing webcam feed, establishing screen share, establishing remote control |
| Travel Reduction Attributable to Use of Collaboration Live | Intra-procedural (1 day) | Distance between the scanning facility and the investigator's location will be recorded (in miles). |
| Ease of Use | Intra-procedural (1 day) | 5-point (Likert) scale data will be reported by the investigator.( 5 = Strongly agree, 4 = Agree, 3 = Neutral, 2 = Disagree, 1 = Strongly disagree) |
| Number of Participants With Technical Issues | Intra-procedural (1 day) | Number of subjects for which device deficiencies are reported |
| Patient Feedback Regarding Remote Consultation | 1 day | Tele-medicine Satisfaction Questionnaire |
| Impact of Remote Consultation on Reimbursement | 30 days | Submitted charges and reimbursement rates for remote patient consultation data will be recorded and compared to standard rates for in-person consultation |
| User Feedback Regarding Streaming, Image Quality and Overall Experience | Intra-procedural (1 day) | 5-point (Likert) scale data will be reported by the investigator. ( 5 = Very good, 4 = Good, 3 = Acceptable, 2 = Poor, 1 = Very Poor) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental - Collaboration Live Software Non-diagnostic software solution: Collaboration Live is a non-diagnostic software solution intended for use with Philips (Philips Ultrasound, 22100 Bothell Everett Highway, Bothell, Washington 98021) EPIQ and Affiniti Series Ultrasound Systems (software version 5.0.2) that allows users to communicate (by text, voice, screen share, webcam video and remote takeover) from an ultrasound system or workstation to a remote destination. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Experimental - Collaboration Live Software |
|---|---|
| Age, Continuous | 28.6 years STANDARD_DEVIATION 7 |
| Body Mass Index | 34.0 kg/m^2 STANDARD_DEVIATION 7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Gestational age | 27.8 weeks STANDARD_DEVIATION 6.6 |
| 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 | 30 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Rate of Clinically Acceptable Performance of Remote Control Functionality
The system responds to the remote input as intended and without a delay interfering with the conduct of the exam. Additionally, a clinically acceptable exam would result in no adverse events related to the control feature
Time frame: Intra-procedural (1 day)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental - Collaboration Live Software | Rate of Clinically Acceptable Performance of Remote Control Functionality | 100 Percentage of total exams |
95% CI: [88.4, 100]
Secondary
Ease of Use
5-point (Likert) scale data will be reported by the investigator.( 5 = Strongly agree, 4 = Agree, 3 = Neutral, 2 = Disagree, 1 = Strongly disagree)
Time frame: Intra-procedural (1 day)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Experimental - Collaboration Live Software | Ease of Use | Physician assessment | Strongly Agree | 26 Participants |
| Experimental - Collaboration Live Software | Ease of Use | Physician assessment | Agree | 4 Participants |
| Experimental - Collaboration Live Software | Ease of Use | Sonographer Assessment | Strongly Agree | 28 Participants |
| Experimental - Collaboration Live Software | Ease of Use | Sonographer Assessment | Agree | 2 Participants |
Secondary
Impact of Remote Consultation on Reimbursement
Submitted charges and reimbursement rates for remote patient consultation data will be recorded and compared to standard rates for in-person consultation
Time frame: 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental - Collaboration Live Software | Impact of Remote Consultation on Reimbursement | 96.9 percentage of standard amount | Standard Deviation 7.2 |
Secondary
Number of Participants With Technical Issues
Number of subjects for which device deficiencies are reported
Time frame: Intra-procedural (1 day)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental - Collaboration Live Software | Number of Participants With Technical Issues | 2 Participants |
Secondary
Patient Feedback Regarding Remote Consultation
Tele-medicine Satisfaction Questionnaire
Time frame: 1 day
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Experimental - Collaboration Live Software | Patient Feedback Regarding Remote Consultation | Good | 0 Participants |
| Experimental - Collaboration Live Software | Patient Feedback Regarding Remote Consultation | Very Good | 30 Participants |
Secondary
Success Rates for Key Tasks in the Collaborative Exam
Establishing the remote connection, establishing text chat, establishing voice call, establishing webcam feed, establishing screen share, establishing remote control
Time frame: Intra-procedural (1 day)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental - Collaboration Live Software | Success Rates for Key Tasks in the Collaborative Exam | 100 percentage of participants |
Secondary
Travel Reduction Attributable to Use of Collaboration Live
Distance between the scanning facility and the investigator's location will be recorded (in miles).
Time frame: Intra-procedural (1 day)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental - Collaboration Live Software | Travel Reduction Attributable to Use of Collaboration Live | 38.0 miles | Standard Deviation 18.6 |
Secondary
User Feedback Regarding Streaming, Image Quality and Overall Experience
5-point (Likert) scale data will be reported by the investigator. ( 5 = Very good, 4 = Good, 3 = Acceptable, 2 = Poor, 1 = Very Poor)
Time frame: Intra-procedural (1 day)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Experimental - Collaboration Live Software | User Feedback Regarding Streaming, Image Quality and Overall Experience | Physician Assessment | Acceptable | 0 Participants |
| Experimental - Collaboration Live Software | User Feedback Regarding Streaming, Image Quality and Overall Experience | Physician Assessment | Good | 3 Participants |
| Experimental - Collaboration Live Software | User Feedback Regarding Streaming, Image Quality and Overall Experience | Physician Assessment | Very Good | 27 Participants |
| Experimental - Collaboration Live Software | User Feedback Regarding Streaming, Image Quality and Overall Experience | Sonorapher | Acceptable | 1 Participants |
| Experimental - Collaboration Live Software | User Feedback Regarding Streaming, Image Quality and Overall Experience | Sonorapher | Good | 4 Participants |
| Experimental - Collaboration Live Software | User Feedback Regarding Streaming, Image Quality and Overall Experience | Sonorapher | Very Good | 25 Participants |