Tele-monitoring of Post Join Arthroplasty Outcomes: A Feasibility Study

NCT04586296 | Completed

• 1 other identifier: IRB-300005894
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to develop an effective telephone mediated follow-up system to reduce the number of unplanned readmissions and emergency department visits after total joint arthroplasty. This will help reduce costs related to unnecessary visits to the hospital as well as catch complications earlier on. The investigators plan to accomplish this by performing a pilot study that will compare the outcomes of using an Interactive Voice Response system through phone call in addition to the standard follow-up protocol. The outcomes of this group will be compared to those receiving the standard of care follow-up protocol.

Conditions

Post-Op Complication

Keywords

telemedicine; knee replacement; hip replacement

Outcome Measures

Primary Outcomes (16)

• Percentage of Patients with acceptable pain control as measured by Visual Analogue scale

  VAS is a patient measured scale to evaluate pain, on a scale of 1-10 with 10 being the worst pain.

  2 week

• Percentage of Patients with acceptable pain control as measured by Visual Analogue scale

  VAS is a patient measured scale to evaluate pain, on a scale of 1-10 with 10 being the worst pain.

  6 weeks

• Percentage of Patients with acceptable pain control as measured by Visual Analogue scale

  VAS is a patient measured scale to evaluate pain, on a scale of 1-10 with 10 being the worst pain.

  12 weeks

• Percentage of Patients with acceptable pain control as measured by Visual Analogue scale

  VAS is a patient measured scale to evaluate pain, on a scale of 1-10 with 10 being the worst pain.

  Baseline

• Percentage of Patients with acceptable joint functionality as measured by hip disability and osteoarthritis outcome score (HOOS)

  HOOS is patient measured scores evaluating Hip function and creates a score out of 100, 100 indicating full functionality.

  Baseline

• Percentage of Patients with acceptable joint functionality as measured by hip disability and osteoarthritis outcome score (HOOS) and knee disability and osteoarthritis outcome score (KOOS)

  KOOS is a patient measured score evaluating Hip function and creates a score out of 100, 100 indicating full functionality.

  Baseline

• Percentage of Patients with acceptable joint functionality as measured by knee disability and osteoarthritis outcome score (KOOS)

  KOOS is a patient measured score evaluating knee function and creates a score out of 100, 100 indicating full functionality.

  2 weeks

• Percentage of Patients with acceptable joint functionality as measured by hip disability and osteoarthritis outcome score (HOOS)

  HOOS is a patient measured score evaluating knee function and creates a score out of 100, 100 indicating full functionality.

  2 weeks

• Percentage of Patients with acceptable joint functionality as measured by hip disability and osteoarthritis outcome score (HOOS)

  HOOS is a patient measured score evaluating Hip function and creates a score out of 100, 100 indicating full functionality.

  6 weeks

• Percentage of Patients with acceptable joint functionality as measured by knee disability and osteoarthritis outcome score (KOOS)

  KOOS is a patient measured score evaluating knee function and creates a score out of 100, 100 indicating full functionality.

  6 weeks

• Percentage of Patients with acceptable joint functionality as measured by hip disability and osteoarthritis outcome score (HOOS)

  HOOS is a patient measured scores evaluating Hip function and creates a score out of 100, 100 indicating full functionality.

  12 weeks

• Percentage of Patients with acceptable joint functionality as measured by knee disability and osteoarthritis outcome score (KOOS)

  KOOS is a patient measured score evaluating Hip and knee function and creates a score out of 100, 100 indicating full functionality.

  12 weeks

• Percentage of Patients with acceptable quality of life as measured by Short Form Health Survey SF-36

  The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.

  Baseline

• Percentage of Patients with acceptable quality of life as measured by Short Form Health Survey SF-36

  The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.

  2 weeks

• Percentage of Patients with acceptable quality of life as measured by Short Form Health Survey SF-36

  The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.

  6 weeks

• Percentage of Patients with acceptable quality of life as measured by Short Form Health Survey SF-36

  The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.

  12 weeks

Study Arms (2)

Telemedicine Group

EXPERIMENTAL

Group that will be receiving the telemedicine intervention in addition to the standard of care post-op.

Other: Telemedicine

Standard Treatment

NO INTERVENTION

Patients will be receiving the standard of care, post op visits at 2, 6, and 12 weeks.

Interventions

Telemedicine OTHER

IVR will consist of a 3 minute call at a decreasing interval from the time of surgery. Questions will assess pain control, signs of infection, prosthesis failure.

Also known as: Integrated Voice Response (IVR)

Telemedicine Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants eligible to undergo the TJA surgical procedure

You may not qualify if:

• Participants who are not eligible to undergo the TJA surgical procedure

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB Highland Hospital

Birmingham, Alabama, 35205, United States

Location

MeSH Terms

Conditions

Postoperative Complications

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Sameer Naranje, MD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 14, 2020
• Study Start: March 16, 2021
• Primary Completion: August 15, 2023
• Study Completion: August 16, 2023
• Last Updated: August 16, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)