Clinical trial NCT03481595: Improvement of Patient Satisfaction and Overall Outcomes Using HealthLoop
Official title: Improvement of Patient Satisfaction and Overall Outcomes Using HealthLoop to Manage the Episode of Care for THA and TKA Bundles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty, Replacement, Knee
Arthroplasty, Replacement, Hip
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Accelero Health Partners, LLC
name: Zimmer Biomet
First posted: 2018-03-29
Enrollment: 294
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility 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

Primary outcomes:
measure: Percentage of Participants Reporting a Problem Across al PPE-15 Domains
timeFrame: 90 days after index surgery
Secondary outcomes:
measure: Visual Analog Scale (VAS) for Patient Satisfaction
timeFrame: 90 days after index surgery
measure: Length of Hospital Stay
timeFrame: 90 days after index surgery
measure: Number of Participants Discharged to Home
timeFrame: 90 days after index surgery
measure: Number Participants Who Were Readmitted to the Hospital
timeFrame: 90 days after index surgery
measure: Number Participants Who Visited the Emergency Department
timeFrame: 90 days after index surgery
measure: Number Participants With 0, 1, 2, or 3+ Outpatient Visits
timeFrame: 90 days after index surgery
measure: Number of Participants Who Made 0, 1, 2, or 3+ Telephone Calls to the Surgical Team
timeFrame: 90 days after index surgery
measure: Number of Participants Who Had a Reoperation
timeFrame: 90 days after index surgery
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Carlos A Higuera, MD
role: PRINCIPAL_INVESTIGATOR
References: