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| Name | Class |
|---|---|
| Accelero Health Partners, LLC | OTHER |
| Zimmer Biomet | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | No Intervention | 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. | |
| Group B | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HealthLoop mobile application | Device | Patients will utilize the HealthLoop mobile application on their mobile device during the post-operative period in addition to standard, routine medical care. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos A Higuera, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Group B |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | percent of participants | 90 days after index surgery |
|
90 days following total knee or total hip arthroplasty
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| swelling | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carlos Higuera | Cleveland Clinic Florida | 9546595430 | higuerc@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 30, 2019 | Oct 28, 2021 | Prot_SAP_001.pdf |
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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 |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 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. | Posted | Mean | Standard Deviation | days | 90 days after index surgery |
|
|
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| Secondary | Number of Participants Discharged to Home | Was the patient routinely discharged to home? Reported as yes or no. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 90 days after index surgery |
|
|
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| 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. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 90 days after index surgery |
|
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| 0 |
| 143 |
| 11 |
| 143 |
| 12 |
| 143 |
| EG001 | 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. | 1 | 127 | 14 | 127 | 10 | 127 |
| Manipulation under anesthesia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Hyperkalemia | Endocrine disorders | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
|
| Effusions | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Gastrointestinal bleed | Gastrointestinal disorders | Systematic Assessment |
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| deep vein thrombosis | Vascular disorders | Systematic Assessment |
|
| Cellulitis | Infections and infestations | Systematic Assessment |
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| Seizure | Nervous system disorders | Systematic Assessment |
|
| Allergy | Immune system disorders | Systematic Assessment |
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| Transverse myelitis | Nervous system disorders | Systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | Systematic Assessment |
|
| GI distress | Gastrointestinal disorders | Systematic Assessment |
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| pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Suture abscess | Infections and infestations | Systematic Assessment |
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| Sepsis | Infections and infestations | Systematic Assessment |
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| Hiccups (hospitalized) | Nervous system disorders | Systematic Assessment |
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| hypotension | General disorders | Systematic Assessment |
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| UTI | Renal and urinary disorders | Systematic Assessment |
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| nausea | General disorders | Systematic Assessment |
|
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| 2 follow up visits |
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| 3 or more follow up visits |
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| 2 phone encounters |
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| 3 or more phone encounters |
|