Chronic Diseases in Children
Conditions
Keywords
Comprehensive Care, Telemedicine enhanced with TytoCare devices., Telemedicine, children with medical complexity
Brief summary
The purpose of this study is to assess if the benefits for children with medical complexity (CMC) receiving comprehensive care (CC) in an enhanced medical home can be further improved by enhanced telemedicine program (ETM) provided during clinic hours using mobile devices to measure temperature and oxygen saturation, auscultate the heart & lungs, and view the skin, throat, and tympanic membranes in the home.
Interventions
OTHERComprehensive care (CC) program
To promote prompt effective care for medically complex children at all hours, the investigators developed an outpatient comprehensive care (CC) program at the University of Texas Health Science Center at Houston, which includes 1) a clinic component with both specialist and primary care in the same clinic, 24/7 direct cell phone access to PCPs at all hours, same weekday care for acute illnesses, and a high staff-to-patient-ratio; 2) a hospital component with consultation service provided by PCPs to help optimize treatment, assure ED physicians and hospitalists are well informed, and coordinate discharge planning; and 3) a conventional telemedicine (CTM) program during regular clinic hours to respond to calls from parents seeking medical advice, to evaluate and recommend treatment for minor illnesses, to schedule a clinic visit if an in-person assessment is needed and to conduct appropriate follow-up visits.
DEVICEEnhanced telemedicine (ETM)
An enhanced telemedicine program (using the HIPAA-compliant, mobile TytoCare exam kit device) will be added to CC to allow providers to remotely visualize the skin, throat, \& ears, auscultate the heart \& lungs, and measure illnesses during clinic hours and chronic illnesses during the detailed patient evaluation to be conducted at least every 6 months by "virtual patient rounds" in the home. These visits will involve the parent(s), the primary care physician (PCP), and if needed, any of 10 specialists, particularly pulmonology, gastroenterology, neurology, and physical medicine and rehabilitation. A social worker, nutritionist, or psychologist will be involved as needed. Each PCP will perform 2-3 virtual patient rounds per week to proactively identify medical problems, suboptimal adherence to treatment, dosing errors, or other problems and intervene before CMC develop a serious illness or require avoidable clinic visits, Emergency Department visits, or hospitalizations.
Sponsors
The University of Texas Health Science Center, Houston
The Systems and Policy Research Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* Greater than or equal to 2 hospitalizations or greater than or equal to 1 ICU admission in the year before joining the comprehensive care program * Greater than 50 percent estimated risk of hospitalization without our care as judged by the medical director
Exclusion criteria
* Major heart disease * Mitochondrial disorders * Active cancer * Do-Not-Resuscitate (DNR) order * Patients receiving compassionate care
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Days Care Provided in a Medical Setting | end of study(about 24 months) |
| Total Number of Episodes of Serious Illnesses (Causing Death, Pediatric ICU Admission, and Hospital Stay > 7d). | end of study(about 24 months) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost Effectiveness of ETM | end of study(about 24 months) | this is defined strictly as a reduction in serious illnesses without an increase in health system costs, a decrease in health system costs without an increase in serious illnesses, or a reduction in both |
| Number of Hospital Admissions Due to All-Cause Infections | end of study(about 24 months) | — |
| Average Numbers of Clinic Visits | end of study(about 24 months) | — |
| Average Total Number of Emergency Department Visits | end of study(about 24 months) | — |
| Average Number of Hospital Days | end of study(about 24 months) | — |
| Average Number of Pediatric Intensive Care Unit (PICU) Days | end of study(about 24 months) | — |
| Total Number of Deaths | end of study(about 24 months) | — |
| Parent Ratings of Care Assessed Using the Consumer Assessment of Healthcare Providers and Systems Survey | end of study(about 24 months) | This survey consists of 5 questions. The first 4 are scored from 1(never)-4(always) for a maximum score of 16 , a higher number indicating better care. The fifth question is scored form 0-10 a higher number indicating a better provider. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRicardo A Mosquera, MD
The University of Texas Health Science Center, Houston
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 6.4 years STANDARD_DEVIATION 3.99 |
| Race/Ethnicity, Customized Black | 62 Participants |
| Race/Ethnicity, Customized Hispanic | 124 Participants |
| Race/Ethnicity, Customized Non-Hispanic white | 12 Participants |
| Race/Ethnicity, Customized Other | 39 Participants |
| Region of Enrollment United States | 124 participants |
| Sex: Female, Male Female | 50 Participants |
| Sex: Female, Male Male | 151 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 124 | 6 / 130 |
| other Total, other adverse events | 0 / 124 | 0 / 130 |
| serious Total, serious adverse events | 0 / 124 | 0 / 130 |
Outcome results
None listed