Improvement of Patient Satisfaction and Overall Outcomes Using HealthLoop

• ClinicalTrials.gov Identifier: NCT03481595
• Recruitment Status: Completed
• First Posted: March 29, 2018
• Results First Posted: November 24, 2021
• Last Update Posted: November 24, 2021
• Sponsor: The Cleveland Clinic
• Collaborators: Accelero Health Partners, LLC; Zimmer Biomet
• Information provided by (Responsible Party): Carlos Higuera-Rueda, The Cleveland Clinic

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Arthroplasty, Replacement, Knee; Arthroplasty, Replacement, Hip	Device: HealthLoop mobile application	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 294 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Improvement of Patient Satisfaction and Overall Outcomes Using HealthLoop to Manage the Episode of Care for THA and TKA Bundles
• Actual Study Start Date: April 17, 2018
• Actual Primary Completion Date: June 17, 2020
• Actual Study Completion Date: June 17, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants Reporting a Problem Across al PPE-15 Domains [ Time Frame: 90 days after index surgery ]
   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.

Secondary Outcome Measures :

1. Visual Analog Scale (VAS) for Patient Satisfaction [ Time Frame: 90 days after index surgery ]
   Satisfaction measurement tool measured on a scale from 0-100 mm. Where 0 = not satisfied and 100 = entirely satisfied.
2. Length of Hospital Stay [ Time Frame: 90 days after index surgery ]
   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.
3. Number of Participants Discharged to Home [ Time Frame: 90 days after index surgery ]
   Was the patient routinely discharged to home? Reported as yes or no.
4. Number Participants Who Were Readmitted to the Hospital [ Time Frame: 90 days after index surgery ]
   A count of the number of hospital readmissions related to the index procedure within 90 days after the index procedure.
5. Number Participants Who Visited the Emergency Department [ Time Frame: 90 days after index surgery ]
   A count of the number of emergency department visits related to the index procedure within 90 days after the index procedure.
6. Number Participants With 0, 1, 2, or 3+ Outpatient Visits [ Time Frame: 90 days after index surgery ]
   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.
7. Number of Participants Who Made 0, 1, 2, or 3+ Telephone Calls to the Surgical Team [ Time Frame: 90 days after index surgery ]
   A count of the number of telephone calls with the surgical team related to the index procedure within 90 days after the index procedure.
8. Number of Participants Who Had a Reoperation [ Time Frame: 90 days after index surgery ]
   A count of the number of reoperations related to the index procedure within 90 days after the index procedure.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Ohio

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Sponsors and Collaborators

The Cleveland Clinic

Accelero Health Partners, LLC

Zimmer Biomet

Investigators

• Principal Investigator: Carlos A Higuera, MD; The Cleveland Clinic

  Study Documents (Full-Text)

Documents provided by Carlos Higuera-Rueda, The Cleveland Clinic:

Study Protocol and Statistical Analysis Plan  [PDF] July 30, 2019

More Information

• Responsible Party: Carlos Higuera-Rueda, Vice Chair for Quality and Patient Safety, The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT03481595
• Other Study ID Numbers: 17-1496
• First Posted: March 29, 2018
• Results First Posted: November 24, 2021
• Last Update Posted: November 24, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes