Improvement of Patient Satisfaction and Overall Outcomes Using HealthLoop

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

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.

Study Overview

• Status: Completed
• Conditions: Arthroplasty, Replacement, Knee; Arthroplasty, Replacement, Hip
• Intervention / Treatment: Device: HealthLoop mobile application

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 294
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Group A; Group A will receive standard, routine medical care. If you are randomized to standard, routine medical care you will need to communicate with your Doctor and clinical care team through conventional methods such as over the phone or through MyChart.
EXPERIMENTAL: Group B; Group B will be asked to use the HealthLoop mobile application on their mobile device during the post-operative period in addition to standard, routine medical care. Patients randomized to use the Health Loop app will be able to communicate with their Doctor and clinical care team directly through the app. Patients will also participate in mobile and web-based surveys, receive reminders related to their healthcare, and receive information personalized to their treatment plan.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Number of Participants Discharged to Home	Was the patient routinely discharged to home? Reported as yes or no.	90 days after index surgery
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
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
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
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
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

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: Zimmer Biomet; Accelero Health Partners, LLC

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 17, 2018
• Primary Completion (ACTUAL): June 17, 2020
• Study Completion (ACTUAL): June 17, 2020

Study Registration Dates

• First Submitted: March 2, 2018
• First Submitted That Met QC Criteria: March 27, 2018
• First Posted (ACTUAL): March 29, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 24, 2021
• Last Update Submitted That Met QC Criteria: October 28, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 17-1496

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes