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

NCT03320122 | Completed

• 1 other identifier: 994055
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatrics; Physical and Rehabilitation Medicine; Physical Therapy Modalities

Keywords

Telemedicine

Outcome Measures

Primary Outcomes (4)

• Parent/Guardian Satisfaction Survey

  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.

  Over 1 day for each patient

• Evidence-Based Hip Surveillance Program Survey

  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.

  Over 1 day for each patient

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

  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.

  Over 1 day for each patient

• Economic Efficiency

  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.

  Up to 4 years

Study Arms (3)

Telemedicine

EXPERIMENTAL

Medical Direction will be provided by pediatric physiatrists using telemedicine.

Other: Telemedicine

In-Person Pediatric Physiatrist

ACTIVE COMPARATOR

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

Other: In-Person Pediatric Physiatrist

In-Person Non-Pediatric Physiatrist

ACTIVE COMPARATOR

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

Other: In-Person Non-Pediatric Physiatrist

Interventions

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.

Telemedicine

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 Pediatric Physiatrist

In-Person Non-Pediatric Physiatrist OTHER

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

In-Person Non-Pediatric Physiatrist

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis, Medical Center

Sacramento, California, 95817, United States

Location

Related Links

• Learn more or sign up for the study here!

MeSH Terms

Interventions

Telemedicine

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• James Marcin, MD, MPH

  UC Davis Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 20, 2017
• First Posted: October 25, 2017
• Study Start: February 1, 2017
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

US (1)