Clinical trial NCT04586296: Tele-monitoring of Post Join Arthroplasty Outcomes: A Feasibility Study
Official title: Tele-monitoring of Post Join Arthroplasty Outcomes: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Op Complication
Keywords: telemedicine
knee replacement
hip replacement
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Percentage of Patients with acceptable pain control as measured by Visual Analogue scale
timeFrame: 2 week
measure: Percentage of Patients with acceptable pain control as measured by Visual Analogue scale
timeFrame: 6 weeks
measure: Percentage of Patients with acceptable pain control as measured by Visual Analogue scale
timeFrame: 12 weeks
measure: Percentage of Patients with acceptable pain control as measured by Visual Analogue scale
timeFrame: Baseline
measure: Percentage of Patients with acceptable joint functionality as measured by hip disability and osteoarthritis outcome score (HOOS)
timeFrame: Baseline
measure: 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)
timeFrame: Baseline
measure: Percentage of Patients with acceptable joint functionality as measured by knee disability and osteoarthritis outcome score (KOOS)
timeFrame: 2 weeks
measure: Percentage of Patients with acceptable joint functionality as measured by hip disability and osteoarthritis outcome score (HOOS)
timeFrame: 2 weeks
measure: Percentage of Patients with acceptable joint functionality as measured by hip disability and osteoarthritis outcome score (HOOS)
timeFrame: 6 weeks
measure: Percentage of Patients with acceptable joint functionality as measured by knee disability and osteoarthritis outcome score (KOOS)
timeFrame: 6 weeks
measure: Percentage of Patients with acceptable joint functionality as measured by hip disability and osteoarthritis outcome score (HOOS)
timeFrame: 12 weeks
measure: Percentage of Patients with acceptable joint functionality as measured by knee disability and osteoarthritis outcome score (KOOS)
timeFrame: 12 weeks
measure: Percentage of Patients with acceptable quality of life as measured by Short Form Health Survey SF-36
timeFrame: Baseline
measure: Percentage of Patients with acceptable quality of life as measured by Short Form Health Survey SF-36
timeFrame: 2 weeks
measure: Percentage of Patients with acceptable quality of life as measured by Short Form Health Survey SF-36
timeFrame: 6 weeks
measure: Percentage of Patients with acceptable quality of life as measured by Short Form Health Survey SF-36
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Highland Hospital
state: Alabama
Study officials:
affiliation: Assistant Professor
name: Sameer Naranje, MD
role: PRINCIPAL_INVESTIGATOR
References: