Arthroplasty, Replacement, HipNCT03499028
Improvement of Patient Satisfaction and Clinical Outcomes Using JointCOACH
A study testing JointCOACH in people with Arthroplasty, Replacement, Hip and Arthroplasty, Replacement, Knee, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee
- What is being tested?
- JointCOACH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 446 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Staged arthroplasty procedure within 6 months of the index procedure
- Abandoned email address of record (e.g. bounce of email from clinic)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- JointCOACH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JointCOACHOther
Patients randomized to this group will utilize JointCOACH to communicate with their surgical team, receive information
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: JointCOACH |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 and 90 days after index surgery
Secondary outcomes (10)
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.
Measured: 30 and 90 days after index surgery
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)
Measured: 90 days after index surgery
Discharge Disposition
Number of patient routinely discharged to home
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 90 days after the last patient enrolled has had surgery. All study-related intervention is complete at this time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start1 May 2018
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthroplasty, Replacement, HipStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 446 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Orthopaedics
- Responsible party
- Sponsor
- Investigators
- Carlos A Higuera, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03499028
- Sponsor's protocol ID
- 18-063
- Status last verified
- Apr 2021
- First submitted
- 9 Apr 2018
- Last updated
- 20 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33581971
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Patient Satisfaction and Clinical Outcomes Using JointCOACH to Manage the Episode of Care for THA and TKA Bundles
- ClinicalTrials.gov ID
- NCT03499028
- Acronym / sponsor ID
- 18-063
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 446 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Stryker Orthopaedics
- Study start
- 1 May 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 17 Apr 2018 (actual)
- Results
- Posted 20 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: JointCOACHThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Staged arthroplasty procedure within 6 months of the index procedure
- Abandoned email address of record (e.g. bounce of email from clinic)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JointCOACHPatients randomized to this group will utilize JointCOACH to communicate with their surgical team, receive information | Other | Experimental (JointCOACH) Group |
Primary outcome
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.
10 secondary outcomes
Visual Analog Scale (VAS) for Patient Satisfaction
Time frame: 30 and 90 days after index surgery
Length of Hospital Stay
Time frame: 90 days after index surgery
Discharge Disposition
Time frame: 90 days after index surgery
Number of Participants With Readmissions
Time frame: 30 and 90 days after index surgery
Number of Participants With Reoperations
Time frame: 30 and 90 days after index surgery
Number of Subjects With Emergency Department Visits
Time frame: 30 and 90 days after index surgery
Number of Outpatient Follow-Up Visits
Time frame: 30 and 90 days after index surgery
Number of Telephone Calls
Time frame: 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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33581971Visperas 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos A Higuera, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JointCOACH in people with Arthroplasty, Replacement, Hip and Arthroplasty, Replacement, Knee, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Picker Patient Experience (PPE-15) Questionnaire (time frame: 30 and 90 days after index surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03499028, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2021.