Improvement of Patient Satisfaction and Overall Outcomes Using HealthLoop

Arthroplasty, Replacement, Knee Clinical Trial

Official title:

Improvement of Patient Satisfaction and Overall Outcomes Using HealthLoop to Manage the Episode of Care for THA and TKA Bundles

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03481595
• Other study ID #: 17-1496
• Status: Completed
• Phase: N/A
• Start date: April 17, 2018
• Est. completion date: June 17, 2020

Study information

• Verified date: October 2021
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the usefulness and results of orthopedic patients having access to a cell phone App called HealthLoop to utilize during the postoperative time period, compared to patients who have the usual postoperative management. The researchers want to investigate whether there any differences in outcomes and satisfaction in patients and providers.

Description:

The purpose of this study is to assess the usefulness and results of orthopedic patients having access to a cell phone App called HealthLoop to utilize during the postoperative time period, compared to patients who have the usual postoperative management. The researchers want to investigate whether there any differences in outcomes and satisfaction in patients and providers.

HealthLoop is a mobile-device application (cell phone App) that allows physicians to monitor for signs and symptoms of potential adverse events, and communicate with patients during the postoperative recovery process. The platform enables doctors to identify patients at risk of decline in the follow up period. Patients are engaged through mobile and web-based surveys, reminders, and information personalized to the patient's specific condition or treatment plan. Alerts are sent to physicians about patients who are at risk of treatment failures, complications, or hospital readmissions. Physicians are informed if patients are trending toward an adverse outcome based on the patient's responses.

Patients who choose to participate in this Research Study will be randomly assigned (like a flip of a coin) to one of two groups. Group A will receive standard, routine medical care. Group B will be asked to use the HealthLoop application on their mobile device during the post-operative period in addition to standard, routine medical care. Patients will not be able to choose which group they will be in.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 294
• Est. completion date: June 17, 2020
• Est. primary completion date: June 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Primary total hip arthroplasty or total knee arthroplasty patient

• Personal or surrogate consent to participate

• Patient has internet access or mobile access with a valid email address at the time of enrollment

Exclusion Criteria:

• Staged arthroplasty procedure within 6 months of the index procedure

• Abandoned email address of record

• Less than 14 days until date of surgery

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip
• Arthroplasty, Replacement, Knee

Intervention

Device:
• HealthLoop mobile application
Patients will utilize the HealthLoop mobile application on their mobile device during the post-operative period in addition to standard, routine medical care.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
The Cleveland Clinic	Accelero Health Partners, LLC, Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Reporting a Problem Across al PPE-15 Domains	15-item patient experience questionnaire. Each response will be categorized as a problem or non-problem and reported as the percent of respondents reporting a problem, averaged across all PPE-15 domains.	90 days after index surgery
Secondary	Visual Analog Scale (VAS) for Patient Satisfaction	Satisfaction measurement tool measured on a scale from 0-100 mm. Where 0 = not satisfied and 100 = entirely satisfied.	90 days after index surgery
Secondary	Length of Hospital Stay	A count of the number of days the patient was admitted to the hospital after the index procedure prior to being discharged. Measured in days.	90 days after index surgery
Secondary	Number of Participants Discharged to Home	Was the patient routinely discharged to home? Reported as yes or no.	90 days after index surgery
Secondary	Number Participants Who Were Readmitted to the Hospital	A count of the number of hospital readmissions related to the index procedure within 90 days after the index procedure.	90 days after index surgery
Secondary	Number Participants Who Visited the Emergency Department	A count of the number of emergency department visits related to the index procedure within 90 days after the index procedure.	90 days after index surgery
Secondary	Number Participants With 0, 1, 2, or 3+ Outpatient Visits	A count of the number of outpatient follow-up visits with the surgical team related to the index procedure within 90 days after the index procedure.	90 days after index surgery
Secondary	Number of Participants Who Made 0, 1, 2, or 3+ Telephone Calls to the Surgical Team	A count of the number of telephone calls with the surgical team related to the index procedure within 90 days after the index procedure.	90 days after index surgery
Secondary	Number of Participants Who Had a Reoperation	A count of the number of reoperations related to the index procedure within 90 days after the index procedure.	90 days after index surgery