Telehealth Following Orthopaedic Procedures | NCT03922737

Studies
Telehealth Following Orthopaedic Procedures

NCT03922737

Sponsor

Rothman Institute Orthopaedics

Status

Unknown status

Last Update Posted

Apr 22, 2019Actual

Enrollment

198Estimated

Phase

Not Applicable

Conditions

Post-Op Complication

Interventions

In-person office visit
Teleheath visit

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 6, 2017Actual

Primary Completion Date

Jun 1, 2019Estimated

Completion Date

Dec 1, 2019Estimated

First Submitted Date

Apr 17, 2019

First Submission Date that Met QC Criteria

Apr 19, 2019

First Posted Date

Apr 22, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2019

Last Update Posted Date

Apr 22, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to evaluate the quality of care provided by a home-based teleheath program as a safe and acceptable alternative to an in-person office visit as determined by satisfaction with the program and the amount of further medical management required by the patients.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

198Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
In-person office visit	Active Comparator		Procedure: In-person office visit
Telehealth visit with provider	Active Comparator		Procedure: Teleheath visit

Interventions

Name	Type	Description	Arm Group Labels	Other Names
In-person office visit	Procedure	Post-operative visit to occur in-person with provider	In-person office visit

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient Satisfaction: Likert Score	Likert Score self-reported patient satisfaction	2 mont post-operative period following surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1. Subjects over 18 and under 75 years of age undergoing elective primary orthopaedic surgery at Thomas Jefferson University Hospital, Rothman Orthopaedic Specialty Hospital or Methodist Hospital who have the capability to utilize a telecommunications platform (computer, tablet or similar device at home with a webcam, microphone and access to high-speed internet).

Exclusion Criteria:

Subjects who are unable to access the telemedicine platform or who are uncomfortable with following up in this fashion
Subjects who are unable or unwilling to provide post-operative radiographs electronically or who are unable or unwilling to obtain them
Subjects with workman's compensation or automotive claims or other ongoing litigation
Subjects that are unable or unwilling to consent for enrollment
Patients under the age of 18 years
Pregnant or breastfeeding women
Patients undergoing surgery for tumor, trauma or infection or who require revision or staged procedures
Patients without English-language proficiency
Patients with unforeseen intra-operative or perioperative complications

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms