Trial Outcomes & Findings for Improvement of Patient Satisfaction and Clinical Outcomes Using JointCOACH (NCT NCT03499028)
NCT ID: NCT03499028
Last Updated: 2021-04-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
446 participants
Primary outcome timeframe
30 and 90 days after index surgery
Results posted on
2021-04-20
Participant Flow
Recruitment period - May 2018 - March 2020 Recruitment location - single large academic healthcare system
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.
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
226
|
220
|
|
Overall Study
COMPLETED
|
204
|
195
|
|
Overall Study
NOT COMPLETED
|
22
|
25
|
Reasons for withdrawal
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
12
|
9
|
|
Overall Study
Withdrawal by Subject
|
5
|
8
|
|
Overall Study
Unplanned SNF discharge
|
5
|
8
|
Baseline Characteristics
Improvement of Patient Satisfaction and Clinical Outcomes Using JointCOACH
Baseline characteristics by cohort
| Measure |
Standard of Care Group
n=204 Participants
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
n=195 Participants
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
|
Total
n=399 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 10 • n=99 Participants
|
66 years
STANDARD_DEVIATION 9 • n=107 Participants
|
65 years
STANDARD_DEVIATION 10 • n=206 Participants
|
|
Sex: Female, Male
Female
|
113 Participants
n=99 Participants
|
102 Participants
n=107 Participants
|
215 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
91 Participants
n=99 Participants
|
93 Participants
n=107 Participants
|
184 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
195 Participants
n=99 Participants
|
189 Participants
n=107 Participants
|
384 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
204 participants
n=99 Participants
|
195 participants
n=107 Participants
|
399 participants
n=206 Participants
|
|
Body Mass Index (BMI)
|
32.04 kg/m^2
STANDARD_DEVIATION 5.9 • n=99 Participants
|
31.48 kg/m^2
STANDARD_DEVIATION 2.85 • n=107 Participants
|
31.76 kg/m^2
STANDARD_DEVIATION 5.83 • n=206 Participants
|
|
Age-Adjusted Charlson Comorbidity Index
|
2.67 index score
STANDARD_DEVIATION 1.6 • n=99 Participants
|
2.85 index score
STANDARD_DEVIATION 1.7 • n=107 Participants
|
2.75 index score
STANDARD_DEVIATION 1.62 • n=206 Participants
|
|
Education Level
Did Not Complete High School
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Education Level
High School
|
47 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
94 Participants
n=206 Participants
|
|
Education Level
Some College
|
58 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
122 Participants
n=206 Participants
|
|
Education Level
Bachelor's Degree
|
57 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
|
Education Level
Master's Degree
|
26 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Education Level
Advanced
|
14 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Employment Status
Unemployed
|
11 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Employment Status
Employed
|
84 Participants
n=99 Participants
|
76 Participants
n=107 Participants
|
160 Participants
n=206 Participants
|
|
Employment Status
Homemaker
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Employment Status
Retired
|
108 Participants
n=99 Participants
|
108 Participants
n=107 Participants
|
216 Participants
n=206 Participants
|
|
ASA Classification
I
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
ASA Classification
II
|
67 Participants
n=99 Participants
|
68 Participants
n=107 Participants
|
135 Participants
n=206 Participants
|
|
ASA Classification
III
|
133 Participants
n=99 Participants
|
123 Participants
n=107 Participants
|
256 Participants
n=206 Participants
|
|
ASA Classification
IV
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Diagnosis
Osteoarthritis
|
190 Participants
n=99 Participants
|
188 Participants
n=107 Participants
|
378 Participants
n=206 Participants
|
|
Diagnosis
Osteonecrosis
|
9 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Diagnosis
Post-traumatic Osteoarthritis
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Diagnosis
Rheumatoid Arthritis
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Diagnosis
Other
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 30 and 90 days after index surgeryIt 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.
Outcome measures
| Measure |
Standard of Care Group
n=204 Participants
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
n=195 Participants
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
|
|---|---|---|
|
Picker Patient Experience (PPE-15) Questionnaire
30 days after index surgery
|
13 percentage of problem responses
Standard Deviation 18
|
13 percentage of problem responses
Standard Deviation 18
|
|
Picker Patient Experience (PPE-15) Questionnaire
90 days after index surgery
|
11.1 percentage of problem responses
Standard Deviation 16
|
12.3 percentage of problem responses
Standard Deviation 17
|
SECONDARY outcome
Timeframe: 30 and 90 days after index surgeryIt is a satisfaction measurement tool using a scale from 0-100, where 0 = completely dissatisfied and 100 = completely satisfied.
Outcome measures
| Measure |
Standard of Care Group
n=204 Participants
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
n=195 Participants
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
|
|---|---|---|
|
Visual Analog Scale (VAS) for Patient Satisfaction
30 days after index surgery
|
94.2 score on a scale
Standard Deviation 12.4
|
93.6 score on a scale
Standard Deviation 10.6
|
|
Visual Analog Scale (VAS) for Patient Satisfaction
90 days after index surgery
|
94.2 score on a scale
Standard Deviation 11.1
|
94.7 score on a scale
Standard Deviation 9.9
|
SECONDARY outcome
Timeframe: 90 days after index surgeryIt 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)
Outcome measures
| Measure |
Standard of Care Group
n=204 Participants
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
n=195 Participants
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
|
|---|---|---|
|
Length of Hospital Stay
|
1.4 days
Standard Deviation 0.8
|
1.5 days
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: 90 days after index surgeryNumber of patient routinely discharged to home
Outcome measures
| Measure |
Standard of Care Group
n=204 Participants
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
n=195 Participants
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
|
|---|---|---|
|
Discharge Disposition
|
199 Participants
|
187 Participants
|
SECONDARY outcome
Timeframe: 30 and 90 days after index surgeryIt is a count of the number patients with hospital readmissions related to the index procedure within 30 and 90 days after the index procedure.
Outcome measures
| Measure |
Standard of Care Group
n=204 Participants
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
n=195 Participants
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
|
|---|---|---|
|
Number of Participants With Readmissions
30 days after surgery
|
0 Participants
|
1 Participants
|
|
Number of Participants With Readmissions
90 days after surgery
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 30 and 90 days after index surgeryIt is a count of the number of reoperations related to the index procedure within 30 and 90 days after the index procedure.
Outcome measures
| Measure |
Standard of Care Group
n=204 Participants
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
n=195 Participants
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
|
|---|---|---|
|
Number of Participants With Reoperations
30 days after surgery
|
0 Participants
|
0 Participants
|
|
Number of Participants With Reoperations
90 days after surgery
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 and 90 days after index surgeryIt 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.
Outcome measures
| Measure |
Standard of Care Group
n=204 Participants
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
n=195 Participants
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
|
|---|---|---|
|
Number of Subjects With Emergency Department Visits
30 days after surgery
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Emergency Department Visits
90 days after surgery
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 and 90 days after index surgeryIt 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.
Outcome measures
| Measure |
Standard of Care Group
n=204 Participants
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
n=195 Participants
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
|
|---|---|---|
|
Number of Outpatient Follow-Up Visits
30 days after surgery
|
0.80 visits
Standard Deviation 0.49
|
0.80 visits
Standard Deviation 0.55
|
|
Number of Outpatient Follow-Up Visits
90 days after surgery
|
1.79 visits
Standard Deviation 0.56
|
1.84 visits
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: 30 and 90 days after index surgeryIt 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.
Outcome measures
| Measure |
Standard of Care Group
n=204 Participants
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
n=195 Participants
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
|
|---|---|---|
|
Number of Telephone Calls
30 days after surgery
|
1.28 calls
Standard Deviation 1.61
|
1.31 calls
Standard Deviation 1.58
|
|
Number of Telephone Calls
90 days after surgery
|
2.03 calls
Standard Deviation 2.15
|
2.06 calls
Standard Deviation 2.25
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Standard of Care Group
n=10 Participants
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
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
|
|---|---|---|
|
Provider Satisfaction Survey- JointCOACH Satisfaction
Very Unsatisfied
|
0 Participants
|
—
|
|
Provider Satisfaction Survey- JointCOACH Satisfaction
Unsatisfied
|
0 Participants
|
—
|
|
Provider Satisfaction Survey- JointCOACH Satisfaction
Neutral
|
3 Participants
|
—
|
|
Provider Satisfaction Survey- JointCOACH Satisfaction
Satisfied
|
5 Participants
|
—
|
|
Provider Satisfaction Survey- JointCOACH Satisfaction
Very Satisfied
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Standard of Care Group
n=10 Participants
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
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
|
|---|---|---|
|
Provider Satisfaction Survey- JointCOACH Recommendation
Very Unlikely
|
0 Participants
|
—
|
|
Provider Satisfaction Survey- JointCOACH Recommendation
Unlikely
|
0 Participants
|
—
|
|
Provider Satisfaction Survey- JointCOACH Recommendation
Neutral
|
4 Participants
|
—
|
|
Provider Satisfaction Survey- JointCOACH Recommendation
Likely
|
4 Participants
|
—
|
|
Provider Satisfaction Survey- JointCOACH Recommendation
Very Likely
|
2 Participants
|
—
|
Adverse Events
Standard of Care Group
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental (JointCOACH) Group
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard of Care Group
n=204 participants at risk
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
n=195 participants at risk
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
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Manipulation Under Anesthesia
|
0.98%
2/204 • 3 month period after surgery
Adverse events were manually collected
|
0.51%
1/195 • 3 month period after surgery
Adverse events were manually collected
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place