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CompletedNCT03499028Updated Apr 20, 2021Results posted

Improvement of Patient Satisfaction and Clinical Outcomes Using JointCOACH

An interventional study of JointCOACH in Arthroplasty, Replacement, Hip and Arthroplasty, Replacement, Knee, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-20.

Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
446
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Arthroplasty, Replacement, Hip
  • Arthroplasty, Replacement, Knee
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Staged arthroplasty procedure within 6 months of the index procedure
  • Abandoned email address of record (e.g. bounce of email from clinic)
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
446 participants (actual)

Study arms

  • 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.

    Other: JointCOACH

Interventions

  • OtherJointCOACH

    Patients randomized to this group will utilize JointCOACH to communicate with their surgical team, receive information

05

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Discharge Disposition

    Number of patient routinely discharged to home

    Time frame: 90 days after index surgery

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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.

  10. 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.

06

Results

Posted Apr 20, 2021

Participant flow

Recruitment period - May 2018 - March 2020 Recruitment location - single large academic healthcare system

Participant flow — Overall Study
MilestoneStandard of Care GroupExperimental (JointCOACH) Group
Started226220
Completed204195
Not completed2225
Withdrew: Lost to follow-up129
Withdrew: Withdrawal by subject58
Withdrew: Unplanned snf discharge58

Outcome measures

PrimaryPicker 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
Reported as:
Mean · percentage of problem responses
Picker Patient Experience (PPE-15) Questionnaire
percentage of problem responsesStandard of Care GroupExperimental (JointCOACH) Group
30 days after index surgery13 ± 1813 ± 18
90 days after index surgery11.1 ± 1612.3 ± 17
SecondaryVisual 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
Reported as:
Mean · score on a scale
Visual Analog Scale (VAS) for Patient Satisfaction
score on a scaleStandard of Care GroupExperimental (JointCOACH) Group
30 days after index surgery94.2 ± 12.493.6 ± 10.6
90 days after index surgery94.2 ± 11.194.7 ± 9.9
SecondaryLength 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
Reported as:
Mean · days
Length of Hospital Stay
daysStandard of Care GroupExperimental (JointCOACH) Group
Length of Hospital Stay1.4 ± 0.81.5 ± 0.8
SecondaryDischarge Disposition

Number of patient routinely discharged to home

Time frame:
90 days after index surgery
Reported as:
Count of participants · Participants
Discharge Disposition
ParticipantsStandard of Care GroupExperimental (JointCOACH) Group
Discharge Disposition199187
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With Readmissions
ParticipantsStandard of Care GroupExperimental (JointCOACH) Group
30 days after surgery01
90 days after surgery23
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With Reoperations
ParticipantsStandard of Care GroupExperimental (JointCOACH) Group
30 days after surgery00
90 days after surgery00
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Subjects With Emergency Department Visits
ParticipantsStandard of Care GroupExperimental (JointCOACH) Group
30 days after surgery01
90 days after surgery01
SecondaryNumber 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
Reported as:
Mean · visits
Number of Outpatient Follow-Up Visits
visitsStandard of Care GroupExperimental (JointCOACH) Group
30 days after surgery0.80 ± 0.490.80 ± 0.55
90 days after surgery1.79 ± 0.561.84 ± 0.6
SecondaryNumber 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
Reported as:
Mean · calls
Number of Telephone Calls
callsStandard of Care GroupExperimental (JointCOACH) Group
30 days after surgery1.28 ± 1.611.31 ± 1.58
90 days after surgery2.03 ± 2.152.06 ± 2.25
SecondaryProvider 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.
Reported as:
Count of participants · Participants
Provider Satisfaction Survey- JointCOACH Satisfaction
ParticipantsProvider Satisfaction
Very Unsatisfied0
Unsatisfied0
Neutral3
Satisfied5
Very Satisfied2
SecondaryProvider 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.
Reported as:
Count of participants · Participants
Provider Satisfaction Survey- JointCOACH Recommendation
ParticipantsProvider Satisfaction
Very Unlikely0
Unlikely0
Neutral4
Likely4
Very Likely2

Adverse events

Collected over 3 month period after surgery. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Standard of Care Group0/204 (0%)2/204 (1%)0/204 (0%)
Experimental (JointCOACH) Group0/195 (0%)1/195 (0.5%)0/195 (0%)
Most frequent serious events
Most frequent serious events
EventStandard of Care GroupExperimental (JointCOACH) Group
Manipulation Under AnesthesiaMusculoskeletal and connective tissue disorders2/2041/195

Baseline characteristics

Age, Continuous
Age, Continuous(years)Standard of Care GroupExperimental (JointCOACH) GroupTotal
Mean65 ± 1066 ± 965 ± 10
Sex: Female, Male
Sex: Female, Male(Participants)Standard of Care GroupExperimental (JointCOACH) GroupTotal
Female113102215
Male9193184
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Standard of Care GroupExperimental (JointCOACH) GroupTotal
American Indian or Alaska Native000
Asian101
Native Hawaiian or Other Pacific Islander000
Black or African American8513
White195189384
More than one race011
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)Standard of Care GroupExperimental (JointCOACH) GroupTotal
United States204195399
Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m^2)Standard of Care GroupExperimental (JointCOACH) GroupTotal
Mean32.04 ± 5.931.48 ± 2.8531.76 ± 5.83
Age-Adjusted Charlson Comorbidity Index
Age-Adjusted Charlson Comorbidity Index(index score)Standard of Care GroupExperimental (JointCOACH) GroupTotal
Mean2.67 ± 1.62.85 ± 1.72.75 ± 1.62
Education Level
Education Level(Participants)Standard of Care GroupExperimental (JointCOACH) GroupTotal
Did Not Complete High School202
High School474794
Some College5864122
Bachelor's Degree5743100
Master's Degree262652
Advanced141529
Employment Status
Employment Status(Participants)Standard of Care GroupExperimental (JointCOACH) GroupTotal
Unemployed11617
Employed8476160
Homemaker156
Retired108108216

2 further baseline measures are reported on the registry.

07

Study locations

1 site
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
08

References and documents

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 documents

  • Protocol and statistical analysis plan · Dec 19, 2018

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03499028
Lead sponsor
The Cleveland Clinic
Collaborators
Stryker Orthopaedics
Responsible party
Sponsor
First posted
Apr 17, 2018
Start date
May 1, 2018
Primary completion
Jun 30, 2020
Completion
Jun 30, 2020
Results posted
Apr 20, 2021
Last update
Apr 20, 2021

Study contacts

Carlos A Higuera, MD
principal investigator · The Cleveland Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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