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Completed

NCT Number: NCT03320122

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

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.

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Key information

Conditions

Pediatrics Physical Therapy Modalities Physical and Rehabilitation Medicine

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Davis, Medical Center

Sacramento, California, 95817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telemedicine

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

Other

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

In-Person Non-Pediatric Physiatrist

Other

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

Primary outcomes

  1. Parent/Guardian Satisfaction Survey

    Time frame: Over 1 day for each patient

    The effect of providing pediatric physiatrist medical direction across groups will be measured through satisfaction surveys that will be distributed to participating parents and guardians. Satisfaction surveys will utilize a seven-point Likert scale and the investigators will assess the inter-item reliability, dimensionality and construct validity of satisfaction scales using standard multivariable analysis techniques. A higher score represents a higher satisfaction rate. The investigators postulate that a minimally important clinically significant difference is approximately 0.50 points, while a difference of 0.30 is tolerably close for purposes of non-inferiority.

  2. Evidence-Based Hip Surveillance Program Survey

    Time frame: Over 1 day for each patient

    The hip surveillance survey utilizes several Yes/No responses to compare guideline adherence between the three cohorts and the questions are directly linked to the clinical expectations and explicit guidelines for the appropriate timing and frequency of x-rays and exams. Adherence rates will be compared by adjusted odds ratios.

  3. European Quality of Life-5 Dimensions (EQ-5D) Survey

    Time frame: Over 1 day for each patient

    The EQ-5D is a quality of life assessment tool for measuring "utility." The "utility" is a comprehensive health measure, ranging from 0 (death) to 1 (perfect health), based on an individual's health state in five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The utility for a certain health condition is calculated by applying an established formula that assigns weights to each of the levels in each dimension determined by this health condition. These data on a quality of life will be used in a cost-effectiveness analysis.

  4. Economic Efficiency

    Time frame: Up to 4 years

    Cost analysis will estimate cost changes resulting from the introduction of this new model of care from the perspectives of patients and families, physicians and healthcare providers, and payers. The proposed economic evaluative methods will integrate all of the effectiveness results from patient encounter data and EQ-5D survey data. Cost analysis will estimate return-on-investment indicating the cost-saving amount per $1 investment in telemedicine compared to MTUs without telemedicine.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

School-Based Tele-Physiatry Assistance for Rehabilitative and Therapeutic Services for Children With Special Health Care Needs Living in Rural and Underserved Communities

Acronym: STARS

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Oct 25, 2017
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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