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Tele-Clinic Visits in Pediatric Marfan Patients Using Parental Echo: The Future?

Primary Purpose

Marfan Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tele-Clinic Visits Using Parent-Acquired Echos
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Marfan Syndrome

Eligibility Criteria

5 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 5-19 years of age (patient)
  • seen in at least 2 prior clinic visits
  • Marfan syndrome by revised Ghent criteria
  • presence of parent at home

Exclusion Criteria:

  • prior aortic surgery
  • known cardiomyopathy
  • known arrhythmia
  • aortic root > 4.5 cm in prior clinic visit
  • pregnancy

Sites / Locations

  • Lucile Packard Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tele-Visit Using Parental Home Echo

Arm Description

All parents will have hands-on echo training. We will test if a tele-visit using parental home echo is clinically reliable compared to an on-site clinic visit, costs less, and improves parental sense of empowerment.

Outcomes

Primary Outcome Measures

Percent of tele-visits with a clinical visit match-score of ≥13/15 points
This scoring system was determined after surveying pediatric MFS physicians nationwide and includes these sections: Echo, vital signs, height and weight, interim medical history, cardiac auscultation, and determination of follow up time and medication dose/type.

Secondary Outcome Measures

To test if a tele-visit using parental home echo costs less than an on-site clinic visit.
The outcome will be the costs of tele-visit and clinic visit. Two cost components will be estimated and combined costs will be compared: (1) Payer cost: Actual cost to deliver a tele-visit with home echo (as it is not currently covered by insurance) vs. Medical or private insurance reimbursement rates for clinic visit with an echo; and (2) Patient-cost: time and travel costs for parents.
To test if a tele-visit using parental home echo costs less than an on-site clinic visit.
Secondary outcome will be lost school time for the patient.
To determine if this intervention increases parental sense of empowerment.
The outcome will be the change in Family Empowerment Score (a validated questionnaire to assess empowerment in parents of children with illness) from study start to study end.
To determine if this intervention increases parental sense of empowerment.
Secondary outcomes will be parent/patient satisfaction survey results for televisits and clinic visits using the CAHPS survey for Children, as well as patient, parent and physician interviews.

Full Information

First Posted
June 18, 2018
Last Updated
March 15, 2021
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT03581682
Brief Title
Tele-Clinic Visits in Pediatric Marfan Patients Using Parental Echo: The Future?
Official Title
Tele-Clinic Visits in Pediatric Marfan Patients Using Parental Echo: The Future?
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
August 1, 2020 (Actual)
Study Completion Date
August 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Marfan syndrome (MFS), a connective tissue disorder seen in 1 in 3,000 individuals, causes progressive aortic root dilation that can result in aortic dissection and sudden death. Clinical care focuses on monitoring the aortic root by serial echocardiography (echo) to guide medical treatment and elective aortic root surgery in a specialized clinic every 6-12 months. This monitoring protocol, coupled with surgical intervention, has doubled the median life expectancy which was previously only 32 years. However, this surveillance carries significant health care costs at >$50 million dollars/year on echos alone (at $3-4K each) in children and adolescents in the US, as well as substantial burden on families residing far from specialized centers. A clinic visit delivered to MFS patients via live-video conferencing at home (tele-visit) could shift this paradigm, if a home echo could be obtained. Here, the investigator will train parents of Pediatric Marfan patients to take echo images using a hand held device, height, weight, blood pressure, medical history, and listen to the heart of their child. Then, the investigators will ask them to take the equipment home and collect the same data at home during a tele-clinic visit, with further instruction by the study team through secure live-video conferencing.
Detailed Description
In the proposed intervention, every patient (n=60) will have a tele-visit and an on-site clinic visit 1 day apart. Parents will have a 1-hour hands-on training session to acquire basic echo images on their children with the same hand-held device that will be used during the tele-visit. Tele-visit elements will include interim medical history by the parent and patient, and weight, height, vital signs, digital cardiac auscultation, and home echo (transferred via Internet for remote interpretation), all obtained by the parent. Two MFS physicians, following our routine MFS care protocol, will administer either the tele-visit or on-site clinic visit, masked to the findings of the other. Two independent echo readers will analyze home and clinic echos to measure reproducibility.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marfan Syndrome

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tele-Visit Using Parental Home Echo
Arm Type
Experimental
Arm Description
All parents will have hands-on echo training. We will test if a tele-visit using parental home echo is clinically reliable compared to an on-site clinic visit, costs less, and improves parental sense of empowerment.
Intervention Type
Other
Intervention Name(s)
Tele-Clinic Visits Using Parent-Acquired Echos
Intervention Description
Every patient will have a tele-visit and an on-site clinic visit 1 day apart 3-6 months after the training session. Parents will have a 1-hour hands-on training session to acquire basic echo images on their children with the same hand-held device that they will use during the tele-visit. The parents will also have an in-service on how to take weight, height, and blood pressure measurements, and how to use the digital stethoscope. A tele-visit will be schedule a day prior to the patient's regularly scheduled clinic visit. Tele-visit elements will include interim medical history by the parent and patient, and weight, height, vital signs, digital cardiac auscultation, and home echo, all obtained by the parent. Two MFS physicians, following our routine MFS care protocol, will administer either the tele-visit or on-site clinic visit, masked to the findings of the other.
Primary Outcome Measure Information:
Title
Percent of tele-visits with a clinical visit match-score of ≥13/15 points
Description
This scoring system was determined after surveying pediatric MFS physicians nationwide and includes these sections: Echo, vital signs, height and weight, interim medical history, cardiac auscultation, and determination of follow up time and medication dose/type.
Time Frame
3-6 months
Secondary Outcome Measure Information:
Title
To test if a tele-visit using parental home echo costs less than an on-site clinic visit.
Description
The outcome will be the costs of tele-visit and clinic visit. Two cost components will be estimated and combined costs will be compared: (1) Payer cost: Actual cost to deliver a tele-visit with home echo (as it is not currently covered by insurance) vs. Medical or private insurance reimbursement rates for clinic visit with an echo; and (2) Patient-cost: time and travel costs for parents.
Time Frame
3-6 months
Title
To test if a tele-visit using parental home echo costs less than an on-site clinic visit.
Description
Secondary outcome will be lost school time for the patient.
Time Frame
3-6 months
Title
To determine if this intervention increases parental sense of empowerment.
Description
The outcome will be the change in Family Empowerment Score (a validated questionnaire to assess empowerment in parents of children with illness) from study start to study end.
Time Frame
3-6 months
Title
To determine if this intervention increases parental sense of empowerment.
Description
Secondary outcomes will be parent/patient satisfaction survey results for televisits and clinic visits using the CAHPS survey for Children, as well as patient, parent and physician interviews.
Time Frame
3-6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 5-19 years of age (patient) seen in at least 2 prior clinic visits Marfan syndrome by revised Ghent criteria presence of parent at home Exclusion Criteria: prior aortic surgery known cardiomyopathy known arrhythmia aortic root > 4.5 cm in prior clinic visit pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seda Tierney, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lucile Packard Children's Hospital
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33453199
Citation
Chen A, Punn R, Collins RT, Chen JH, Stauffer KJ, Wang R, Alexander S, MacMillen Lechich K, Murphy DJ, Chung S, Selamet Tierney ES. Tele-Clinic Visits in Pediatric Patients with Marfan Syndrome Using Parentally Acquired Echocardiography. J Pediatr. 2021 May;232:140-146. doi: 10.1016/j.jpeds.2021.01.004. Epub 2021 Jan 13.
Results Reference
derived

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Tele-Clinic Visits in Pediatric Marfan Patients Using Parental Echo: The Future?

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