- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03499028
Improvement of Patient Satisfaction and Clinical Outcomes Using JointCOACH
April 19, 2021 updated by: The Cleveland Clinic
Improvement of Patient Satisfaction and Clinical Outcomes Using JointCOACH to Manage the Episode of Care for THA and TKA Bundles
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
446
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Cleveland Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
NO_INTERVENTION: 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: 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.
|
Patients randomized to this group will utilize JointCOACH to communicate with their surgical team, receive information
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Picker Patient Experience (PPE-15) Questionnaire
Time Frame: 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.
|
30 and 90 days after index surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale (VAS) for Patient Satisfaction
Time Frame: 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.
|
30 and 90 days after index surgery
|
|
Length of Hospital Stay
Time Frame: 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)
|
90 days after index surgery
|
|
Discharge Disposition
Time Frame: 90 days after index surgery
|
Number of patient routinely discharged to home
|
90 days after index surgery
|
|
Number of Participants With Readmissions
Time Frame: 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.
|
30 and 90 days after index surgery
|
|
Number of Participants With Reoperations
Time Frame: 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.
|
30 and 90 days after index surgery
|
|
Number of Subjects With Emergency Department Visits
Time Frame: 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.
|
30 and 90 days after index surgery
|
|
Number of Outpatient Follow-Up Visits
Time Frame: 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.
|
30 and 90 days after index surgery
|
|
Number of Telephone Calls
Time Frame: 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.
|
30 and 90 days after index surgery
|
|
Provider Satisfaction Survey- JointCOACH Satisfaction
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.
|
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
Time Frame: 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.
|
90 days after the last patient enrolled has had surgery. All study-related intervention is complete at this time.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 1, 2018
Primary Completion (ACTUAL)
June 30, 2020
Study Completion (ACTUAL)
June 30, 2020
Study Registration Dates
First Submitted
April 9, 2018
First Submitted That Met QC Criteria
April 9, 2018
First Posted (ACTUAL)
April 17, 2018
Study Record Updates
Last Update Posted (ACTUAL)
April 20, 2021
Last Update Submitted That Met QC Criteria
April 19, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 18-063
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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