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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03481595

Enrollment

294

Registered

2018-03-29

Start date

2018-04-17

Completion date

2020-06-17

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee

Brief summary

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.

Interventions

DEVICEHealthLoop 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants Reporting a Problem Across al PPE-15 Domains	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

Measure	Time frame	Description
Number of Participants Discharged to Home	90 days after index surgery	Was the patient routinely discharged to home? Reported as yes or no.
Number Participants Who Were Readmitted to the Hospital	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.
Number Participants Who Visited the Emergency Department	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.
Length of Hospital Stay	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.
Number of Participants Who Made 0, 1, 2, or 3+ Telephone Calls to the Surgical Team	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.
Visual Analog Scale (VAS) for Patient Satisfaction	90 days after index surgery	Satisfaction measurement tool measured on a scale from 0-100 mm. Where 0 = not satisfied and 100 = entirely satisfied.
Number of Participants Who Had a Reoperation	90 days after index surgery	A count of the number of reoperations related to the index procedure within 90 days after the index procedure.
Number Participants With 0, 1, 2, or 3+ Outpatient Visits	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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.	143
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. 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.	127
Total	270

Baseline characteristics

Characteristic	Group A	Group B	Total
Age, Continuous	66 years STANDARD_DEVIATION 9	65 years STANDARD_DEVIATION 8	66 years STANDARD_DEVIATION 8
Race and Ethnicity Not Collected	—	—	0 Participants
Sex: Female, Male Female	81 Participants	67 Participants	148 Participants
Sex: Female, Male Male	62 Participants	60 Participants	122 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 143	1 / 127
other Total, other adverse events	12 / 143	10 / 127
serious Total, serious adverse events	11 / 143	14 / 127

Outcome results

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.