NCT03961711

Brief Summary

The objective of this study is to evaluate patient perspective on telemedicine used in 3 week post operative visits for knee and hip arthroplasty. It is hypothesized that patient satisfaction with telemedicine follow-up is equal to patient satisfaction with in-office followup. Patient satisfaction will be assessed at the 3-week and 9-week post-operative timepoints.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2019

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 23, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2020

Completed
Last Updated

August 4, 2020

Status Verified

August 1, 2020

Enrollment Period

1 year

First QC Date

May 22, 2019

Last Update Submit

August 3, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patient reported satisfaction

    Client Satisfaction Questionnaire (CSQ-8) will be used to assess patient satisfaction of the 3 week encounter both at 3 and 9 weeks post-operatively. The scale of the survey ranges from 8-32, with 32 being the best score and 8 being the worst. The higher a patient scores, the more satisfied the patient is with the care provided.

    9 weeks

Other Outcomes (4)

  • Patient reported pain level

    9 weeks

  • Adverse Events

    9 weeks

  • Time spent during 3-week post-operative encounter

    3 weeks

  • +1 more other outcomes

Study Arms (2)

Telemedicine encounter

EXPERIMENTAL

Patients will undergo a Telemedicine encounter with the physician at the 3-week post-operative timepoint following a total hip or total knee arthroplasty.

Procedure: Telemedicine

In-person Clinic Visit

ACTIVE COMPARATOR

Patients will undergo an in-person clinic encounter with the physician at the 3-week post-operative timepoint following a total hip or total knee arthroplasty.

Procedure: In-Person Clinic Visit

Interventions

TelemedicinePROCEDURE

Patients will undergo a Telemedicine encounter with the physician at the 3-week post-operative timepoint following a total hip or total knee arthroplasty.

Telemedicine encounter

Patients will undergo an in-person clinic encounter with the physician at the 3-week post-operative timepoint following a total hip or total knee arthroplasty.

In-person Clinic Visit

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • There will be two arms of this study, knee and hip patients.

You may not qualify if:

  • lack of access to a telephone
  • history of wound complications
  • venous thromboembolism (deep vein thrombosis and/or pulmonary embolism),
  • significant cardiac history (myocardial infarction, angina, stroke, lower limb ischemia)
  • Subject with any condition (including cognitive impairment) that, in the opinion of the investigator, might interfere with the evaluation of the study objectives.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Steadman Hawkins Clinic of the Carolinas

Greenville, South Carolina, 29615, United States

Location

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis, Hip

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Brian Burnikel, MD

    Steadman Hawkins Clinic of the Carolinas - Greenville Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2019

First Posted

May 23, 2019

Study Start

May 10, 2019

Primary Completion

May 22, 2020

Study Completion

May 22, 2020

Last Updated

August 4, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations