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OpenTrials
Completed

NCT Number: NCT04586296

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

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.

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Key information

Conditions

Post-Op Complication Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UAB Highland Hospital

Birmingham, Alabama, 35205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants eligible to undergo the TJA surgical procedure

Exclusion criteria

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

Treatment and study plan

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.

Other names: Integrated Voice Response (IVR)

Primary outcomes

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

    Time frame: 2 week

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

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

    Time frame: 6 weeks

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

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

    Time frame: 12 weeks

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

  6. 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)

    Time frame: Baseline

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

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

    Time frame: 2 weeks

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

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

    Time frame: 2 weeks

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

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

    Time frame: 6 weeks

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

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

    Time frame: 6 weeks

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

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

    Time frame: 12 weeks

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

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

    Time frame: 12 weeks

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

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

    Time frame: Baseline

    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.

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

    Time frame: 2 weeks

    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.

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

    Time frame: 6 weeks

    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.

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

    Time frame: 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 14, 2020
Registry last updated
Aug 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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