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

NCT ID: NCT04586296

Last Updated: 2023-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-16
• Study Completion Date: 2023-08-16

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.

Detailed Description

Upon patient education and consent to participate in this study, patients will be randomized via online randomizer during their baseline visit into either Treatment As Usual (TAU) or Integrated Voice Response (IVR) cohorts. During this baseline visit, the patients in the IVR group will be given specific information on the nature of the calls and what to expect. Both groups will fill out a form for assessing their baseline pain and functionality. Both groups will receive standard total joint arthroplasty. After this, the TAU group will receive the standard of care which involves appropriate pain management and scheduled clinic follow-ups lasting approximately 60 minutes at 2 weeks, 6 weeks, and 12 weeks along with additional visits if required. Clinic visits will assess pain via VAS scale, joint functionality via HOOS and KOOS scale, and quality of life via SF-36.

In addition to the standard of care follow-up visits as in the TAU group, the IVR group will also receive automated phone calls lasting up to 3 minutes, which will be the focus of this research study. These phone calls will be daily for the first week, every other day the second week, twice a week for weeks 3-6, and weekly for weeks 7-12. The content of these calls will assess pain management, wound healing and screen for potential complications through a series of questions (questionnaire script attached). At the completion of each call, the patient will be instructed to either continue standard treatment or visit the emergency department based on the content of their response. If there is reason for concern, the PI will automatically be informed.

Survey questions pertaining to the patients outcomes and satisfaction will be completed in clinic and collected by the PI. The responses and data relating to IVR calls will made available through computer software designed by our team on the secure REDcap network.

Conditions

Post-Op Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Telemedicine Group

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

Group Type: EXPERIMENTAL

Telemedicine

Intervention Type: 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.

Standard Treatment

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Telemedicine

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.

Intervention Type: OTHER

Other Intervention Names

Integrated Voice Response (IVR)

Eligibility Criteria

Inclusion Criteria

• Participants eligible to undergo the TJA surgical procedure

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Sameer Naranje

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sameer Naranje, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

UAB Highland Hospital

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

IRB-300005894

Identifier Type: -

Identifier Source: org_study_id