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| Name | Class |
|---|---|
| Stryker Orthopaedics | INDUSTRY |
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JointCOACH is a web-based communication platform that enables joint replacement patients to communicate with their care team via computer or smartphone throughout their episode of care, from the time that surgery is scheduled until at least 90 days postoperatively.
Patients will receive the following information at key intervals: 1) instructions about how to prepare for surgery, 2) information about the procedure, 3) information about medications and pain control, 4) information about postoperative recovery and rehabilitation. In addition, several surveys will be distributed using JointCOACH to keep patients involved in their own recovery and to keep the surgical team informed of their progress. The proposed research will help determine if JointCOACH can improve patient satisfaction and clinical outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care Group | No Intervention | The Standard of Care Group will receive standard, routine medical care and will communicate with their surgeon and clinical care team through conventional methods such as phone. | |
| Experimental (JointCOACH) Group | Experimental | The Experimental Group will receive standard, routine medical care and utilize a web-based communication platform called JointCOACH to communicate with their care team via computer or smartphone throughout their episode of care. They will also receive information personalized to their treatment plan and will be asked to complete online questionnaires. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JointCOACH | Other | Patients randomized to this group will utilize JointCOACH to communicate with their surgical team, receive information |
|
| Measure | Description | Time Frame |
|---|---|---|
| Picker Patient Experience (PPE-15) Questionnaire | It is a 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. | 30 and 90 days after index surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) for Patient Satisfaction | It is a satisfaction measurement tool using a scale from 0-100, where 0 = completely dissatisfied and 100 = completely satisfied. | 30 and 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33581971 | Derived | Visperas AT, Greene KA, Krebs VE, Klika AK, Piuzzi NS, Higuera-Rueda CA. A Web-Based Interactive Patient-Provider Software Platform Does Not Increase Patient Satisfaction or Decrease Hospital Resource Utilization in Total Knee and Hip Arthroplasty Patients in a Single Large Hospital System. J Arthroplasty. 2021 Jul;36(7):2290-2296.e1. doi: 10.1016/j.arth.2021.01.037. Epub 2021 Jan 21. |
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Patients were consented and randomized into the standard of care (SOC) or JointCOACH group during the same visit. Since patients were randomized at time of consent, those that eventually had cancelled surgeries were removed from the Total Started in Participant Flow.
Recruitment period - May 2018 - March 2020 Recruitment location - single large academic healthcare system
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care Group | The Standard of Care Group will receive standard, routine medical care and will communicate with their surgeon and clinical care team through conventional methods such as phone. |
| FG001 | Experimental (JointCOACH) Group | The Experimental Group will receive standard, routine medical care and utilize a web-based communication platform called JointCOACH to communicate with their care team via computer or smartphone throughout their episode of care. They will also receive information personalized to their treatment plan and will be asked to complete online questionnaires. JointCOACH: Patients randomized to this group will utilize JointCOACH to communicate with their surgical team, receive information |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care Group | The Standard of Care Group will receive standard, routine medical care and will communicate with their surgeon and clinical care team through conventional methods such as phone. |
| BG001 | Experimental (JointCOACH) Group |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Picker Patient Experience (PPE-15) Questionnaire | It is a 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 | percentage of problem responses | 30 and 90 days after index surgery |
|
3 month period after surgery
Adverse events were manually collected
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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 | Standard of Care Group | The Standard of Care Group will receive standard, routine medical care and will communicate with their surgeon and clinical care team through conventional methods such as phone. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Manipulation Under Anesthesia | Musculoskeletal and connective tissue disorders | Systematic Assessment | Manipulation Under Anesthesia is done to increase range of motion after total joint arthroplasty. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anabelle Visperas | Cleveland Clinic | 216-444-2416 | vispera@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 | Dec 19, 2018 | Sep 8, 2020 | Prot_SAP_000.pdf |
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It is 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 |
| Discharge Disposition | Number of patient routinely discharged to home | 90 days after index surgery |
| Number of Participants With Readmissions | It is a count of the number patients with hospital readmissions related to the index procedure within 30 and 90 days after the index procedure. | 30 and 90 days after index surgery |
| Number of Participants With Reoperations | It is a count of the number of reoperations related to the index procedure within 30 and 90 days after the index procedure. | 30 and 90 days after index surgery |
| Number of Subjects With Emergency Department Visits | It is a count of the number of subjects with emergency department visits related to the index procedure within 30 and 90 days after the index procedure. | 30 and 90 days after index surgery |
| Number of Outpatient Follow-Up Visits | It is a count of the number of outpatient follow-up visits with the surgical team related to the index procedure within 30 and 90 days after the index procedure. | 30 and 90 days after index surgery |
| Number of Telephone Calls | It is a count of the number of telephone calls with the surgical team related to the index procedure within 30 and 90 days after the index procedure. | 30 and 90 days after index surgery |
| Provider Satisfaction Survey- JointCOACH Satisfaction | It is a 2 question survey regarding provider experience using JointCOACH measured using a 5-point Likert scale, where 1 = very dissatisfied and 5 = very satisfied. | 90 days after the last patient enrolled has had surgery. approximately 22 months after the first patient enrolled. All study-related intervention is complete at this time. |
| Provider Satisfaction Survey- JointCOACH Recommendation | It is a 2 question survey regarding provider experience using JointCOACH measured using a 5-point Likert scale, where 1 = very dissatisfied and 5 = very satisfied. | 90 days after the last patient enrolled has had surgery. All study-related intervention is complete at this time. |
| Unplanned SNF discharge |
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The Experimental Group will receive standard, routine medical care and utilize a web-based communication platform called JointCOACH to communicate with their care team via computer or smartphone throughout their episode of care. They will also receive information personalized to their treatment plan and will be asked to complete online questionnaires. JointCOACH: Patients randomized to this group will utilize JointCOACH to communicate with their surgical team, receive information |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Age-Adjusted Charlson Comorbidity Index | Age-adjusted Charlson Comorbidity Score is derived by the summation of the weighted scores of 19 medical conditions found to be associated with survival and age. The lower the score the healthier the patient. The higher the score, the higher morbidity. Range is from 0-37. | Mean | Standard Deviation | index score |
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| Education Level | Count of Participants | Participants |
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| Employment Status | Count of Participants | Participants |
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| ASA Classification | The American Society of Anesthesiologists Physical Status Classification (ASA I to ASA VI) grades patients on their perioperative risk. Examples of ASA classifications include: ASA I - a normal healthy patient, ASA III - a patient with severe systemic disease, ASA V- a moribund patient who is not expected to survive without the operation. | Count of Participants | Participants |
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| Diagnosis | Count of Participants | Participants |
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| Secondary | Visual Analog Scale (VAS) for Patient Satisfaction | It is a satisfaction measurement tool using a scale from 0-100, where 0 = completely dissatisfied and 100 = completely satisfied. | Posted | Mean | Standard Deviation | score on a scale | 30 and 90 days after index surgery |
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| Secondary | Length of Hospital Stay | It is 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 | Discharge Disposition | Number of patient routinely discharged to home | Posted | Count of Participants | Participants | 90 days after index surgery |
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| Secondary | Number of Participants With Readmissions | It is a count of the number patients with hospital readmissions related to the index procedure within 30 and 90 days after the index procedure. | Posted | Count of Participants | Participants | 30 and 90 days after index surgery |
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| Secondary | Number of Participants With Reoperations | It is a count of the number of reoperations related to the index procedure within 30 and 90 days after the index procedure. | Posted | Count of Participants | Participants | 30 and 90 days after index surgery |
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| Secondary | Number of Subjects With Emergency Department Visits | It is a count of the number of subjects with emergency department visits related to the index procedure within 30 and 90 days after the index procedure. | Posted | Count of Participants | Participants | 30 and 90 days after index surgery |
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| Secondary | Number of Outpatient Follow-Up Visits | It is a count of the number of outpatient follow-up visits with the surgical team related to the index procedure within 30 and 90 days after the index procedure. | Posted | Mean | Standard Deviation | visits | 30 and 90 days after index surgery |
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| Secondary | Number of Telephone Calls | It is a count of the number of telephone calls with the surgical team related to the index procedure within 30 and 90 days after the index procedure. | Posted | Mean | Standard Deviation | calls | 30 and 90 days after index surgery |
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| Secondary | Provider Satisfaction Survey- JointCOACH Satisfaction | It is a 2 question survey regarding provider experience using JointCOACH measured using a 5-point Likert scale, where 1 = very dissatisfied and 5 = very satisfied. | Providers - Surgeon (n=4), Physician Assistant (n=2), Nurse Practitioner (n=1), Nurse (n=3). Providers were not considered enrolled but did contribute to this assessment. | Posted | Count of Participants | Participants | 90 days after the last patient enrolled has had surgery. approximately 22 months after the first patient enrolled. All study-related intervention is complete at this time. |
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| Secondary | Provider Satisfaction Survey- JointCOACH Recommendation | It is a 2 question survey regarding provider experience using JointCOACH measured using a 5-point Likert scale, where 1 = very dissatisfied and 5 = very satisfied. | Providers - Surgeon (n=4), Physician Assistant (n=2), Nurse Practitioner (n=1), Nurse (n=3). Providers were not considered enrolled but did contribute to this assessment. | Posted | Count of Participants | Participants | 90 days after the last patient enrolled has had surgery. All study-related intervention is complete at this time. |
|
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| 0 |
| 204 |
| 2 |
| 204 |
| 0 |
| 204 |
| EG001 | Experimental (JointCOACH) Group | The Experimental Group will receive standard, routine medical care and utilize a web-based communication platform called JointCOACH to communicate with their care team via computer or smartphone throughout their episode of care. They will also receive information personalized to their treatment plan and will be asked to complete online questionnaires. JointCOACH: Patients randomized to this group will utilize JointCOACH to communicate with their surgical team, receive information | 0 | 195 | 1 | 195 | 0 | 195 |
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| Satisfied |
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| Very Satisfied |
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| Likely |
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| Very Likely |
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