School-Based Tele-Physiatry Assistance for Rehabilitative and Therapeutic Services (STARS)

University of California (UC) Davis

Status: Completed

Conditions: Pediatrics; Physical and Rehabilitation Medicine; Physical Therapy Modalities

Treatments: Other: In-Person Pediatric Physiatrist; Other: In-Person Non-Pediatric Physiatrist; Other: Telemedicine

Study type: Interventional

Funder types: Other

Identifiers

NCT03320122

994055

Details and patient eligibility

About

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.

Full 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.

Enrollment: 350 patients

Sex: All

Ages: Under 21 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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350 participants in 3 patient groups

Telemedicine

Experimental group

Description:

Medical Direction will be provided by pediatric physiatrists using telemedicine.

Treatment:

Other: Telemedicine

In-Person Pediatric Physiatrist

Active Comparator group

Description:

Medical Direction will be provided by pediatric physiatrists in-person.

Treatment:

Other: In-Person Pediatric Physiatrist

In-Person Non-Pediatric Physiatrist

Active Comparator group

Description:

Medical Direction will be provided by contracted physicians (i.e., non-pediatric physiatrists) in-person care.

Treatment:

Other: In-Person Non-Pediatric Physiatrist