School-Based Tele-Physiatry Assistance for Rehabilitative and Therapeutic Services

NCT ID: NCT03320122

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2023-07-31

Brief Summary

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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

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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.

Conditions

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Pediatrics Physical and Rehabilitation Medicine Physical Therapy Modalities

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Telemedicine

Medical Direction will be provided by pediatric physiatrists using telemedicine.

Group Type EXPERIMENTAL

Telemedicine

Intervention Type OTHER

Medical direction will be provided to MTUs through a video-based conferencing unit. Each telemedicine unit includes a Rubbermaid medical grade cart with a Polycom RealPresence 500 Series high-resolution video-conferencing unit flat screen to display video. Each cart also comes with an Uninterrupted Power Supply (UPS) to make the unit mobile if needed or to properly shut it down in the event of power failure.

In-Person Pediatric Physiatrist

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

Group Type ACTIVE_COMPARATOR

In-Person Pediatric Physiatrist

Intervention Type OTHER

UC Davis pediatric physiatrists will drive out to the school-based MTUs to provide medical direction in person.

In-Person Non-Pediatric Physiatrist

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

Group Type ACTIVE_COMPARATOR

In-Person Non-Pediatric Physiatrist

Intervention Type OTHER

A contracted physician (i.e., a non pediatric physiatrist) would provide medical direction in person.

Interventions

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Telemedicine

Medical direction will be provided to MTUs through a video-based conferencing unit. Each telemedicine unit includes a Rubbermaid medical grade cart with a Polycom RealPresence 500 Series high-resolution video-conferencing unit flat screen to display video. Each cart also comes with an Uninterrupted Power Supply (UPS) to make the unit mobile if needed or to properly shut it down in the event of power failure.

Intervention Type OTHER

In-Person Pediatric Physiatrist

UC Davis pediatric physiatrists will drive out to the school-based MTUs to provide medical direction in person.

Intervention Type OTHER

In-Person Non-Pediatric Physiatrist

A contracted physician (i.e., a non pediatric physiatrist) would provide medical direction in person.

Intervention Type OTHER

Eligibility Criteria

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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.
Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James Marcin, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

UC Davis Health

Locations

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University of California, Davis, Medical Center

Sacramento, California, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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994055

Identifier Type: -

Identifier Source: org_study_id

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