PediatricsSTARSNCT03320122
School-Based Tele-Physiatry Assistance for Rehabilitative and Therapeutic Services
A study testing Telemedicine, In-Person Pediatric Physiatrist and In-Person Non-Pediatric Physiatrist in people with Pediatrics and Physical and Rehabilitation Medicine, run by University of California, Davis at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatrics, Physical and Rehabilitation Medicine, Physical Therapy Modalities
- What is being tested?
- Telemedicine, In-Person Pediatric Physiatrist and In-Person Non-Pediatric Physiatrist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Children with special health care needs not enrolled in the CCS Medical Therapy Program.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis, Medical Center
Sacramento, California, 95817
About this study
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
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.
Read the 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.
- Being tested
- Telemedicine, In-Person Pediatric Physiatrist, In-Person Non-Pediatric Physiatrist
- Keywords
- Telemedicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemedicineOther
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 PhysiatristOther
UC Davis pediatric physiatrists will drive out to the school-based MTUs to provide medical direction in person.
In-Person Non-Pediatric PhysiatristOther
A contracted physician (i.e., a non pediatric physiatrist) would provide medical direction in person.
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine | Experimental | Medical Direction will be provided by pediatric physiatrists using telemedicine. Receives: Other: Telemedicine |
| In-Person Pediatric Physiatrist | Active comparator | Medical Direction will be provided by pediatric physiatrists in-person. Receives: 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. Receives: Other: In-Person Non-Pediatric Physiatrist |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start1 Feb 2017
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PediatricsStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Marcin, MD, MPH, Principal investigator, UC Davis Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03320122
- Sponsor's protocol ID
- 994055
- Acronym
- STARS
- Status last verified
- Nov 2023
- First submitted
- 20 Oct 2017
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03320122
- Acronym / sponsor ID
- STARS / 994055
- Keywords
- Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 25 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Telemedicine | Experimental | Other: TelemedicineMedical Direction will be provided by pediatric physiatrists using telemedicine. |
| In-Person Pediatric Physiatrist | Active comparator | Other: In-Person Pediatric PhysiatristMedical Direction will be provided by pediatric physiatrists in-person. |
| In-Person Non-Pediatric Physiatrist | Active comparator | Other: In-Person Non-Pediatric PhysiatristMedical Direction will be provided by contracted physicians (i.e., non-pediatric physiatrists) in-person care. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Children with special health care needs not enrolled in the CCS Medical Therapy Program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelemedicineMedical 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. | Other | Telemedicine |
| In-Person Pediatric PhysiatristUC Davis pediatric physiatrists will drive out to the school-based MTUs to provide medical direction in person. | Other | In-Person Pediatric Physiatrist |
| In-Person Non-Pediatric PhysiatristA contracted physician (i.e., a non pediatric physiatrist) would provide medical direction in person. | Other | In-Person Non-Pediatric Physiatrist |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Learn more or sign up for the study here!Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Marcin, MD, MPH principal investigator
UC Davis Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine, In-Person Pediatric Physiatrist and In-Person Non-Pediatric Physiatrist in people with Pediatrics and Physical and Rehabilitation Medicine, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent/Guardian Satisfaction Survey (time frame: Over 1 day for each patient). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.