Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERJointCOACH
Patients randomized to this group will utilize JointCOACH to communicate with their surgical team, receive information
Sponsors
Stryker Orthopaedics
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Undergoing primary total hip or primary total knee arthroplasty * Willing to sign an IRB approved informed consent form * Have internet access or mobile access with a valid email address at the time of enrollment * Above the age of 18 years
Exclusion criteria
* Staged arthroplasty procedure within 6 months of the index procedure * Abandoned email address of record (e.g. bounce of email from clinic)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Picker Patient Experience (PPE-15) Questionnaire | 30 and 90 days after index surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospital Stay | 90 days after index surgery | 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) |
| Discharge Disposition | 90 days after index surgery | Number of patient routinely discharged to home |
| Number of Participants With Readmissions | 30 and 90 days after index surgery | 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. |
| Number of Participants With Reoperations | 30 and 90 days after index surgery | It is a count of the number of reoperations related to the index procedure within 30 and 90 days after the index procedure. |
| Visual Analog Scale (VAS) for Patient Satisfaction | 30 and 90 days after index surgery | It is a satisfaction measurement tool using a scale from 0-100, where 0 = completely dissatisfied and 100 = completely satisfied. |
| Number of Outpatient Follow-Up Visits | 30 and 90 days after index surgery | 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. |
| Number of Telephone Calls | 30 and 90 days after index surgery | 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. |
| Provider Satisfaction Survey- JointCOACH Satisfaction | 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. | 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. |
| Provider Satisfaction Survey- JointCOACH Recommendation | 90 days after the last patient enrolled has had surgery. All study-related intervention is complete at this time. | 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. |
| Number of Subjects With Emergency Department Visits | 30 and 90 days after index surgery | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment period - May 2018 - March 2020 Recruitment location - single large academic healthcare system
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 204 |
| 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 | 195 |
| Total | 399 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 12 | 9 |
| Overall Study | Unplanned SNF discharge | 5 | 8 |
| Overall Study | Withdrawal by Subject | 5 | 8 |
Baseline characteristics
| Characteristic | Total | Experimental (JointCOACH) Group | Standard of Care Group |
|---|---|---|---|
| Age-Adjusted Charlson Comorbidity Index | 2.75 index score STANDARD_DEVIATION 1.62 | 2.85 index score STANDARD_DEVIATION 1.7 | 2.67 index score STANDARD_DEVIATION 1.6 |
| Age, Continuous | 65 years STANDARD_DEVIATION 10 | 66 years STANDARD_DEVIATION 9 | 65 years STANDARD_DEVIATION 10 |
| ASA Classification I | 3 Participants | 2 Participants | 1 Participants |
| ASA Classification II | 135 Participants | 68 Participants | 67 Participants |
| ASA Classification III | 256 Participants | 123 Participants | 133 Participants |
| ASA Classification IV | 5 Participants | 2 Participants | 3 Participants |
| Body Mass Index (BMI) | 31.76 kg/m^2 STANDARD_DEVIATION 5.83 | 31.48 kg/m^2 STANDARD_DEVIATION 2.85 | 32.04 kg/m^2 STANDARD_DEVIATION 5.9 |
| Diagnosis Osteoarthritis | 378 Participants | 188 Participants | 190 Participants |
| Diagnosis Osteonecrosis | 12 Participants | 3 Participants | 9 Participants |
| Diagnosis Other | 4 Participants | 2 Participants | 2 Participants |
| Diagnosis Post-traumatic Osteoarthritis | 4 Participants | 1 Participants | 3 Participants |
| Diagnosis Rheumatoid Arthritis | 1 Participants | 1 Participants | 0 Participants |
| Education Level Advanced | 29 Participants | 15 Participants | 14 Participants |
| Education Level Bachelor's Degree | 100 Participants | 43 Participants | 57 Participants |
| Education Level Did Not Complete High School | 2 Participants | 0 Participants | 2 Participants |
| Education Level High School | 94 Participants | 47 Participants | 47 Participants |
| Education Level Master's Degree | 52 Participants | 26 Participants | 26 Participants |
| Education Level Some College | 122 Participants | 64 Participants | 58 Participants |
| Employment Status Employed | 160 Participants | 76 Participants | 84 Participants |
| Employment Status Homemaker | 6 Participants | 5 Participants | 1 Participants |
| Employment Status Retired | 216 Participants | 108 Participants | 108 Participants |
| Employment Status Unemployed | 17 Participants | 6 Participants | 11 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 384 Participants | 189 Participants | 195 Participants |
| Region of Enrollment United States | 399 participants | 195 participants | 204 participants |
| Sex: Female, Male Female | 215 Participants | 102 Participants | 113 Participants |
| Sex: Female, Male Male | 184 Participants | 93 Participants | 91 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 204 | 0 / 195 |
| other Total, other adverse events | 0 / 204 | 0 / 195 |
| serious Total, serious adverse events | 2 / 204 | 1 / 195 |
Outcome results
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.
Time frame: 30 and 90 days after index surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care Group | Picker Patient Experience (PPE-15) Questionnaire | 30 days after index surgery | 13 percentage of problem responses | Standard Deviation 18 |
| Standard of Care Group | Picker Patient Experience (PPE-15) Questionnaire | 90 days after index surgery | 11.1 percentage of problem responses | Standard Deviation 16 |
| Experimental (JointCOACH) Group | Picker Patient Experience (PPE-15) Questionnaire | 30 days after index surgery | 13 percentage of problem responses | Standard Deviation 18 |
| Experimental (JointCOACH) Group | Picker Patient Experience (PPE-15) Questionnaire | 90 days after index surgery | 12.3 percentage of problem responses | Standard Deviation 17 |
Secondary
Discharge Disposition
Number of patient routinely discharged to home
Time frame: 90 days after index surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care Group | Discharge Disposition | 199 Participants |
| Experimental (JointCOACH) Group | Discharge Disposition | 187 Participants |
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)
Time frame: 90 days after index surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care Group | Length of Hospital Stay | 1.4 days | Standard Deviation 0.8 |
| Experimental (JointCOACH) Group | Length of Hospital Stay | 1.5 days | Standard Deviation 0.8 |
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.
Time frame: 30 and 90 days after index surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care Group | Number of Outpatient Follow-Up Visits | 30 days after surgery | 0.80 visits | Standard Deviation 0.49 |
| Standard of Care Group | Number of Outpatient Follow-Up Visits | 90 days after surgery | 1.79 visits | Standard Deviation 0.56 |
| Experimental (JointCOACH) Group | Number of Outpatient Follow-Up Visits | 30 days after surgery | 0.80 visits | Standard Deviation 0.55 |
| Experimental (JointCOACH) Group | Number of Outpatient Follow-Up Visits | 90 days after surgery | 1.84 visits | Standard Deviation 0.6 |
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.
Time frame: 30 and 90 days after index surgery
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard of Care Group | Number of Participants With Readmissions | 30 days after surgery | 0 Participants |
| Standard of Care Group | Number of Participants With Readmissions | 90 days after surgery | 2 Participants |
| Experimental (JointCOACH) Group | Number of Participants With Readmissions | 30 days after surgery | 1 Participants |
| Experimental (JointCOACH) Group | Number of Participants With Readmissions | 90 days after surgery | 3 Participants |
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.
Time frame: 30 and 90 days after index surgery
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard of Care Group | Number of Participants With Reoperations | 30 days after surgery | 0 Participants |
| Standard of Care Group | Number of Participants With Reoperations | 90 days after surgery | 0 Participants |
| Experimental (JointCOACH) Group | Number of Participants With Reoperations | 30 days after surgery | 0 Participants |
| Experimental (JointCOACH) Group | Number of Participants With Reoperations | 90 days after surgery | 0 Participants |
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.
Time frame: 30 and 90 days after index surgery
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard of Care Group | Number of Subjects With Emergency Department Visits | 30 days after surgery | 0 Participants |
| Standard of Care Group | Number of Subjects With Emergency Department Visits | 90 days after surgery | 0 Participants |
| Experimental (JointCOACH) Group | Number of Subjects With Emergency Department Visits | 30 days after surgery | 1 Participants |
| Experimental (JointCOACH) Group | Number of Subjects With Emergency Department Visits | 90 days after surgery | 1 Participants |
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.
Time frame: 30 and 90 days after index surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care Group | Number of Telephone Calls | 30 days after surgery | 1.28 calls | Standard Deviation 1.61 |
| Standard of Care Group | Number of Telephone Calls | 90 days after surgery | 2.03 calls | Standard Deviation 2.15 |
| Experimental (JointCOACH) Group | Number of Telephone Calls | 30 days after surgery | 1.31 calls | Standard Deviation 1.58 |
| Experimental (JointCOACH) Group | Number of Telephone Calls | 90 days after surgery | 2.06 calls | Standard Deviation 2.25 |
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.
Time frame: 90 days after the last patient enrolled has had surgery. All study-related intervention is complete at this time.
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard of Care Group | Provider Satisfaction Survey- JointCOACH Recommendation | Unlikely | 0 Participants |
| Standard of Care Group | Provider Satisfaction Survey- JointCOACH Recommendation | Neutral | 4 Participants |
| Standard of Care Group | Provider Satisfaction Survey- JointCOACH Recommendation | Very Unlikely | 0 Participants |
| Standard of Care Group | Provider Satisfaction Survey- JointCOACH Recommendation | Likely | 4 Participants |
| Standard of Care Group | Provider Satisfaction Survey- JointCOACH Recommendation | Very Likely | 2 Participants |
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.
Time frame: 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.
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard of Care Group | Provider Satisfaction Survey- JointCOACH Satisfaction | Very Unsatisfied | 0 Participants |
| Standard of Care Group | Provider Satisfaction Survey- JointCOACH Satisfaction | Unsatisfied | 0 Participants |
| Standard of Care Group | Provider Satisfaction Survey- JointCOACH Satisfaction | Neutral | 3 Participants |
| Standard of Care Group | Provider Satisfaction Survey- JointCOACH Satisfaction | Satisfied | 5 Participants |
| Standard of Care Group | Provider Satisfaction Survey- JointCOACH Satisfaction | Very Satisfied | 2 Participants |
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.
Time frame: 30 and 90 days after index surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care Group | Visual Analog Scale (VAS) for Patient Satisfaction | 30 days after index surgery | 94.2 score on a scale | Standard Deviation 12.4 |
| Standard of Care Group | Visual Analog Scale (VAS) for Patient Satisfaction | 90 days after index surgery | 94.2 score on a scale | Standard Deviation 11.1 |
| Experimental (JointCOACH) Group | Visual Analog Scale (VAS) for Patient Satisfaction | 30 days after index surgery | 93.6 score on a scale | Standard Deviation 10.6 |
| Experimental (JointCOACH) Group | Visual Analog Scale (VAS) for Patient Satisfaction | 90 days after index surgery | 94.7 score on a scale | Standard Deviation 9.9 |