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The specific aims of the study are to:
Eligible children of interested parent(s) will be randomly assigned to either the control group (standard care) or the intervention group (Tyto device). Randomization will be performed using an online randomization program to generate group assignments for the 25 subjects. Subjects will be stratified by whether they have a tracheostomy or not and be assigned 1.5:1 to achieve 15 children in the device group and 10 children in the control group. Informed consent will be obtained for children in each group.
Children/families in the control group will continue to get usual care through the CCCMC program, and will be able to access their providers via telephone for urgent care needs and scheduled follow up. For evaluation purposes, data collection will include the monthly encounter tracking that is done routinely as part of the CCCMC program, and research surveys completed by both parents and HCPs. Parents will complete a Parent Survey by phone once each month for the 3-month study period. The CCCMC HCPs will complete the Provider Survey electronic survey with each telephone encounter where the HCP would have liked to use the device.
For those assigned to the device group, parents will be instructed to contact their CCCMC HCP as usual, see bullet points above, when health concerns arise and their HCP will decide if she would like a telehealth visit. Telehealth/video visits may also be scheduled in advance as a matter of routine follow-up care. In the event that an exam is deemed necessary by the HCP, the parent or caregiver will be directed to connect via the remote exam device. The provider will conduct a 2-way live interactive audio/video visit with the patient. The parent or caregiver will use the remote exam device to provide temperature, lung sounds, heart sounds, oropharyngeal exam, skin exam and/or ear exam as clinically indicated. Direction for necessary treatment, referral to an ED, clinic or inpatient care will be at the discretion of the CCCMC provider. For evaluation purposes, in addition to the monthly encounter tracking that is done as part of the CCCMC program, both parents and HCPs will complete surveys. Parents will complete a Parent Survey by phone once each month for the 3-month study period. The CCCMC HCPs will complete the Provider Survey via a Qualtrics link with each telehealth encounter.
Additional data collected will include subject demographics, and encounter data that is routinely collected as a part of the CCCMC program. Images of patient encounters will be transmitted in real time via the telemedicine device encrypted software. Provider Survey data will be gathered via Qualtrics. Tyto will retain / store data obtained from device group encounters in a de-identified way for development purposes only.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | Usual care | |
| Telemedicine Group | Experimental | TytoCare Device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TytoCare Device | Device | Tyto is a handheld, mobile device designed for capture and transmission of ear/throat/skin images and lung/heart auscultations. It may be used to perform non-invasive, medical examinations, either on a patient (by another person, most commonly a family member, or by a medical professional) or self-performed by the patient, for remote review by a medical practitioner. It is suitable for use on patients in both clinical and home environment. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of In-person Health Care Encounters | Hospital day length of stay reported as the total number of hospital days in the group. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Provider Survey | Success of connection for telemedicine visits. | 3 months |
| Parent Survey | Overall satisfaction with device, comfort with Device, satisfaction with clinician interactions and development of plans of care; Questions asked using 4 point Likert scale (4 = Very Satisfied , 1=Very Dissatisfied). Higher score more satisfaction |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Patricia M Notario, MD | Advocate Children's Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30628860 | Derived | Notario PM, Gentile E, Amidon M, Angst D, Lefaiver C, Webster K. Home-Based Telemedicine for Children with Medical Complexity. Telemed J E Health. 2019 Nov;25(11):1123-1132. doi: 10.1089/tmj.2018.0186. Epub 2019 Jan 30. |
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Will share only aggregate and overall project results through poster and/or oral presentations at local, regional and national meetings.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Received usual care through the pediatric complex care program at our institution. This included 24/7 availability by the program clinicians for phone calls and electronic message from caregivers. The clinicians provided primary care and consultative services focusing on outpatient comprehensive care visits. The team also provided inpatient consultation. |
| FG001 | Telemedicine Group | Received the TytoCare Device in addition to usual care. TytoCare Device: Tyto is a handheld, mobile device designed for capture and transmission of ear/throat/skin images and lung/heart auscultations. It may be used to perform non-invasive, medical examinations, either on a patient (by another person, most commonly a family member, or by a medical professional) or self-performed by the patient, for remote review by a medical practitioner. It is suitable for use on patients in both clinical and home environment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Received usual care through the pediatric complex care program at our institution. This included 24/7 availability by the program clinicians for phone calls and electronic message from caregivers. The clinicians provided primary care and consultative services focusing on outpatient comprehensive care visits. The team also provided inpatient consultation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Frequency of In-person Health Care Encounters | Hospital day length of stay reported as the total number of hospital days in the group. | Posted | Number | days | 3 months |
|
4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | Received usual care through the pediatric complex care program at our institution. This included 24/7 availability by the program clinicians for phone calls and electronic message from caregivers. The clinicians provided primary care and consultative services focusing on outpatient comprehensive care visits. The team also provided inpatient consultation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patricia M Notario, MD | Billings Clinic | 406-238-2143 | pnotario@billingsclinic.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 29, 2016 | Jul 17, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| 3 months |
| BG001 |
| Telemedicine Group |
Received the TytoCare Device in addition to usual care. TytoCare Device: Tyto is a handheld, mobile device designed for capture and transmission of ear/throat/skin images and lung/heart auscultations. It may be used to perform non-invasive, medical examinations, either on a patient (by another person, most commonly a family member, or by a medical professional) or self-performed by the patient, for remote review by a medical practitioner. It is suitable for use on patients in both clinical and home environment. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Number of specialists involved in the care of the patient | Mean | Standard Deviation | specialists |
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| Trach: present | Count of Participants | Participants |
|
| Number of medical diagnoses active at enrollment | Mean | Standard Deviation | diagnoses |
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| Secondary | Provider Survey | Success of connection for telemedicine visits. | Control group participants did not have data for telemedicine device use as they did not have access to this. | Posted | Count of Units | Visit Connections | 3 months | Visit Connections | Visit Connections |
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| Secondary | Parent Survey | Overall satisfaction with device, comfort with Device, satisfaction with clinician interactions and development of plans of care; Questions asked using 4 point Likert scale (4 = Very Satisfied , 1=Very Dissatisfied). Higher score more satisfaction | Control group participants did not answer questions regarding the tele health device in the satisfaction survey as they did not have access to this. | Posted | Median | Inter-Quartile Range | units on a scale | 3 months |
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|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Telemedicine Group | Received the TytoCare Device in addition to usual care. TytoCare Device: Tyto is a handheld, mobile device designed for capture and transmission of ear/throat/skin images and lung/heart auscultations. It may be used to perform non-invasive, medical examinations, either on a patient (by another person, most commonly a family member, or by a medical professional) or self-performed by the patient, for remote review by a medical practitioner. It is suitable for use on patients in both clinical and home environment. | 0 | 15 | 0 | 15 | 0 | 15 |
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| Connection was problematic for telemedicine visit |
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| Not able to get connection with telemedicine visit |
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| Comfortable with telehealth device |
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| Interaction with clinicians |
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| Complex care program satisfaction |
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