Telehealth Following Orthopaedic Procedures

Evaluation of Telehealth Follow-up Appointments Following Orthopaedic Surgery

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.

Study Overview

• Status: Unknown
• Conditions: Post-Op Complication
• Intervention / Treatment: Procedure: In-person office visit; Procedure: Teleheath visit

• Study Type: Interventional
• Enrollment (Anticipated): 198
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Rothman Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: In-person office visit	Procedure: In-person office visit; Post-operative visit to occur in-person with provider
ACTIVE_COMPARATOR: Telehealth visit with provider	Procedure: Teleheath visit; Post-operative visit to occur via telehealth software platform with provider

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rothman Institute Orthopaedics

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 6, 2017
• Primary Completion (ANTICIPATED): June 1, 2019
• Study Completion (ANTICIPATED): December 1, 2019

Study Registration Dates

• First Submitted: April 17, 2019
• First Submitted That Met QC Criteria: April 19, 2019
• First Posted (ACTUAL): April 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 22, 2019
• Last Update Submitted That Met QC Criteria: April 19, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: 2019Horneff

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No