Clinical trial NCT03320122: School-Based Tele-Physiatry Assistance for Rehabilitative and Therapeutic Services
Official title: School-Based Tele-Physiatry Assistance for Rehabilitative and Therapeutic Services for Children With Special Health Care Needs Living in Rural and Underserved Communities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatrics
Physical and Rehabilitation Medicine
Physical Therapy Modalities
Keywords: Telemedicine
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2017-10-25
Enrollment: 350
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The proposed program will target MTUs and patients in counties were pediatric physiatrists and other multidisciplinary team members are underrepresented. In this proposed model, the investigators will randomly select at least 350 patient encounters: approximately 175 children will receive care using tele-physiatrist medical direction; 101 children will receive care from a pediatric physiatrist who travels to the MTU to provide in-person care; and 74 children will receive care under a non-pediatric specialist's medical directorship. Once the care model has been created at each site, patients from each cohort will be selected using a clustered, clinic based randomization scheme.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Using a randomized trial design, the goal of this project is to prospectively compare outcomes from a telemedicine-based model of care to two cohorts: patients who receive in-person pediatric physiatrist medical direction (the "gold standard"), and those who receive medical oversight from non-specialist community providers. This project will determine the impact of this new model of care using telemedicine on parent/guardian satisfaction, adherence rates to an evidence-based hip surveillance program, and economic efficiency.

Detailed description: During this study, a novel model of care will be developed and tested using telehealth technologies to bring necessary medical expertise to children with special health care needs living in rural and underserved communities. This model of care will be implemented in eight school-based Medical Therapy Units (MTUs) in northern California using a randomized design. The investigators hypothesize that this model of care will result in 1) equal satisfaction of the care received in-person from pediatric physiatrists and increased satisfaction of the care received from non-pediatric specialists; 2) equal adherence rates to an evidence-based hip surveillance program when compared to children who receive care from in-person pediatric physiatry care and better adherence than children who receive care from non-pediatric specialists; and 3) cost savings when compared to medical direction provided in-person by pediatric physiatrists and non-pediatric specialist providers.

The first 6 months of the project will be a "ramp-up" period during which the protocol will be re-reviewed during MTU site visits and necessary contracts and approvals will be in place. The last 6 months will be reserved for data analysis, study closeout, and manuscript preparation. The intervention phase will include various designs of implementation. For those schools currently without pediatric physiatry services, the investigators will provide MTU services using telemedicine and add in-person clinics. For those schools where medical direction is provided by non-pediatric physiatrists, the investigators will augment current services using telemedicine to provide medical direction to some children using pediatric physiatrists. For those schools where pediatric physiatrists travel long distances to provide medical direction during scheduled clinics, the investigators will similarly add additional telemedicine services such that an augmented mixed model of in-person and telemedicine pediatric physiatrist medical direction will be provided.

Eligibility criteria: Inclusion Criteria:

* Participants will include children with special health care needs enrolled in the CCS Medical Therapy Program receiving care at one of the participating sites during the study period.

Exclusion Criteria:

* Children with special health care needs not enrolled in the CCS Medical Therapy Program.

Primary outcomes:
measure: Parent/Guardian Satisfaction Survey
timeFrame: Over 1 day for each patient
measure: Evidence-Based Hip Surveillance Program Survey
timeFrame: Over 1 day for each patient
measure: European Quality of Life-5 Dimensions (EQ-5D) Survey
timeFrame: Over 1 day for each patient
measure: Economic Efficiency
timeFrame: Up to 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis, Medical Center
state: California
Study officials:
affiliation: UC Davis Health
name: James Marcin, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: