Trial Outcomes & Findings for Stroke Team Remote Evaluation Using a Digital Observation Camera (NCT NCT00283868)

NCT ID: NCT00283868

Last Updated: 2015-06-03

Results Overview

This primary measure assesses the appropriateness of decision to treat or not treat with thrombolytics for patients presenting potentially within 3 hours of symptom onset. Appropriateness was assessed using a centralized adjudicating committee, 3 levels of data availability, and an independent medical monitor assessment. The case was presented to the adjudicating committee (blinded to randomization arm) and the committee reviewed patient records (also blinded to randomization arm) to assess whether decision was "appropriate" to give or not give rt-PA.

• Recruitment status: COMPLETED
• Target enrollment: 234 participants
• Primary outcome timeframe: potentially within 3 hours of symptom onset
• Results posted on: 2015-06-03

Participant Flow

Recruitment completed in 4/07

There were 11 initial "run-in" patients used to validate the system but these patients were excluded from the final analysis. There was also 1 patient removed from analysis because of a protocol violation (age < 18) so this patient was excluded rom any analysis (Initial patients=234. 11 Run in=223. 1 removed=222. This accounts for final numbers)

Participant milestones

Measure	Telemedicine Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine	Telephone Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM
Overall Study STARTED	111	111
Overall Study COMPLETED	104	103
Overall Study NOT COMPLETED	7	8

Reasons for withdrawal

Measure	Telemedicine Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine	Telephone Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM
Overall Study Lost to Follow-up	7	8

Baseline Characteristics

Stroke Team Remote Evaluation Using a Digital Observation Camera

Baseline characteristics by cohort

Measure	Telemedicine n=111 Participants Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine	Telephone n=111 Participants Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM	Total n=222 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0.0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	38 Participants n=5 Participants	36 Participants n=7 Participants	74.0 Participants n=5 Participants
Age, Categorical >=65 years	73 Participants n=5 Participants	75 Participants n=7 Participants	148.0 Participants n=5 Participants
Age, Continuous	70.4 years STANDARD_DEVIATION 14.5 • n=5 Participants	69 years STANDARD_DEVIATION 14.9 • n=7 Participants	69.7 years STANDARD_DEVIATION 14.7 • n=5 Participants
Sex: Female, Male Female	57 Participants n=5 Participants	57 Participants n=7 Participants	114.0 Participants n=5 Participants
Sex: Female, Male Male	54 Participants n=5 Participants	54 Participants n=7 Participants	108.0 Participants n=5 Participants
Region of Enrollment United States	111 participants n=5 Participants	111 participants n=7 Participants	222.0 participants n=5 Participants

PRIMARY outcome

Timeframe: potentially within 3 hours of symptom onset

Population: Of the original 234 patients, 11 were run in patients and were not randomized and 1 was removed from any analysis due to a protocol violation resulting in the total 222 patients analyzed. There were 7 lost to follow up in telemedicine and 8 lost to follow up in telephone resulting in 104 analyzed in telemedicine and 103 analyzed in telephone.

This primary measure assesses the appropriateness of decision to treat or not treat with thrombolytics for patients presenting potentially within 3 hours of symptom onset.

Appropriateness was assessed using a centralized adjudicating committee, 3 levels of data availability, and an independent medical monitor assessment. The case was presented to the adjudicating committee (blinded to randomization arm) and the committee reviewed patient records (also blinded to randomization arm) to assess whether decision was "appropriate" to give or not give rt-PA.

Outcome measures

Measure	Telemedicine n=104 Participants Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine	Telephone n=103 Participants Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM
Appropriateness of Decision to Treat or Not Treat With Thrombolytics	98 percentage of participants	82 percentage of participants

SECONDARY outcome

Timeframe: 36 hours

Intracerebral Hemorrhage (ICH) rate at 36 hours. This was assessed by determining whether there was an intracerebral hemmorhage via telephone contact to the hospital where the patient was located. Any follow up imaging (head CT or MRI) was reported to the investigator team for presence of hemorrhage.

Outcome measures

Measure	Telemedicine n=104 Participants Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine	Telephone n=103 Participants Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM
Percentage of Participants With Intracerebral Hemorrhage (ICH)	7 Percentage of participants	8 Percentage of participants

SECONDARY outcome

Timeframe: potentially within 3 hours of symptom onset

This measure assesses the number of total thrombolytic administrations that were given. This was to measure whether there were more participants treated with thrombolytics in one arm of the trial or the other.

Outcome measures

Measure	Telemedicine n=104 Participants Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine	Telephone n=103 Participants Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM
Percentage of Total Thrombolytic Administrations	28 Percentage of participants	23 Percentage of participants

SECONDARY outcome

Timeframe: potentially within 3 hours of symptom onset

time to decision (consult onset to decision). This measure was meant to assess how long it took to do the evaluation.

Outcome measures

Measure	Telemedicine n=104 Participants Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine	Telephone n=103 Participants Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM
Time to Treatment Decision for Administration of Thrombolytics	32 Minutes Standard Deviation 17	23 Minutes Standard Deviation 24

SECONDARY outcome

Timeframe: Time of consultation

Technical Observations: This measure was designed to assess the percentage of evaluations where there were technical observations (difficulties with using the technology) noted by the consultant who performed the evaluation (either telemedicine evaluation or telephone evaluation) in each arm of the trial.

Outcome measures

Measure	Telemedicine n=104 Participants Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine	Telephone n=103 Participants Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM
Percentage of Evaluations With Technical Observations	0 Percentage of Evaluations	12 Percentage of Evaluations

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Brett C. Meyer, MD

University of California, San Diego

Phone: 619-543-7760

Email: bcmeyer@ucsd.edu

Results disclosure agreements

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