Improvement of Patient Satisfaction and Clinical Outcomes Using JointCOACH to Manage the Episode of Care for THA and TKA Bundles
Phase: NA
Conditions: Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee
Sponsor: The Cleveland Clinic

 
 
 
Version Date: 12/19/2018 
Confidential 
Page 1 of 14 
 
 
 
Project Protocol 
 
Improvement of Patient Satisfaction and Clinical Outcomes Using 
JointCOACH to Manage the Episode of Care for THA and TKA Bundles 
 
 
Principle Investigator: Carlos Higuera, MD 
Research Program Manager: Alison Klika, MS 
Research Coordinator: Anabelle Visperas, PhD 
 
 
 

 
 
 
Version Date: 12/19/2018 
Confidential 
Page 2 of 14 
Table of Contents: 
1. Project Summary....…………………………………………………………………….… 3 
2. Introduction and Background…...………………………………………………………... 3 
3. Specific Aims..…………………………………………………………………………… 4 
4. Methods.…….……………………………………………………………………………. 5 
4.1 Study Design..……………………………………………………………………. 5 
4.2 Patient Population..……………………………………………………………….. 6 
4.3 Sample Size Calculation....……………………………………………………….. 7 
4.4 Schedule of Events……………………………………………………………….. 8 
4.5 Data Analysis…………………………………………………………………….. 9 
5. References ……………………………………………………………………………… 10 
6. Appendix………………………………………………………………………………..  11 
6.1 Study Metrics…………………………………………………………………… 11 
6.2 ICD-10 codes for relevant metrics……………………………………………… 12 
6.3 Success Thresholds for Study Metrics………………………………………….. 13 
6.4 Provider Satisfaction Survey……………………………………………………. 14 
 
 

 
 
 
Version Date: 12/19/2018 
Confidential 
Page 3 of 14 
1. Project 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.  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.  
 
2. Introduction and Background 
 
Health systems invest significant resources to improve quality and reduce costs.  However, 
this process is typically driven by hospital administration and staff.  Recently, studies have shown 
that when patients are engaged, they take more responsibility for their own health and preventative 
care.  Additionally, these patients are more satisfied with their healthcare experiences and have 
lower rates of healthcare utilization 1,2.  Physicians are in the best position to promote patient 
engagement since they have direct relationships with their own patients.  However, physicians 
need frictionless tools with minimal implementation barriers in order to create and maintain this 
relationship in the follow up period. 
Patient engagement has been referred to as the next blockbuster “drug”, and increasing 
evidence demonstrates that highly engaged patients not only enjoy improved outcomes, but have 
fewer complications, undergo fewer readmissions, and have lower total costs of care 3–5.  While 
these engagement-related outcomes have been shown in several other specialties, relatively little 
has been done to explore this relationship in orthopedics.  The opportunity to demonstrate the 

 
 
 
Version Date: 12/19/2018 
Confidential 
Page 4 of 14 
impact of engagement on outcomes in the orthopedic space is highlighted by the estimated $1.5B 
of medical expenses occurring nationally due to potentially preventable readmissions following 
orthopedic surgeries alone.   
Stryker Performance Solutions JointCOACH™ and the Cleveland Clinic are interested in 
collaborating on a clinical pilot study to demonstrate that high patient engagement leads to 
enhanced preoperative preparation potentially reducing length of stay (LOS), readmissions and 
reoperations, increasing discharge disposition to home rather than another facility, reducing the 
need for in-person follow up, and increasing patient (and provider) satisfaction after elective 
primary hip and knee arthroplasty (THA and TKA).  These improvements can translate to higher 
financial savings through the episode of care especially in light of the alternative payment models. 
 
3. Specific Aims 
Currently in use by orthopedic groups around the country, JointCOACH improves 
perioperative outcomes after THA and TKA and mitigates risk by: 1) enhancing patient 
engagement with providers, 2) allowing patients to play an integral role in patient-reported 
outcomes, 3) generating and relaying actionable pre- and postoperative reporting directly to the 
clinical team, and 4) detecting impending postoperative complications early, enabling timely 
intervention and preventing avoidable complications and readmissions.  The specific aims of this 
proposal are to: 
1. Measure patient satisfaction with and without use of JointCOACH as a tool for patient 
engagement 
2. Understand the degree to which high postoperative engagement can reduce the amount of 
healthcare resource utilization by answering the following questions: 

 
 
 
Version Date: 12/19/2018 
Confidential 
Page 5 of 14 
a. Will the use of JointCOACH decrease the number of potentially avoidable 
healthcare utilization encounters such as Emergency Department (ED) and 
hospital visits (i.e. readmissions and reoperations)? 
b. Does utilizing JointCOACH improve clinical workflow by minimizing telephone 
calls and thereby offloading support staff, allowing them to be more efficient? 
c. Does utilizing JointCOACH reduce the volume of on-call pages by addressing 
patient questions up front, alleviating concerns, and providing them with the 
information they need when they need it? 
d. Does utilizing JointCOACH allow the practice to identify patients whose in-person 
follow-up needs are minimal? 
3. Measure additional potential benefits including shorter length of hospital stay, discharge 
disposition to home rather than a facility and decreased 90 day readmissions and 
reoperations by answering the following: 
a. Does utilizing JointCOACH lead to early detection of adverse signs/symptoms that 
develop between clinical encounters and result in reduced readmissions and 
reoperations? 
4. Evaluate the financial impact of JointCOACH in the episode of care (% difference in 
Charges between JointCOACH and standard of care groups) 
 
4. Methods  
4.1 Study Design 
The study design is a prospective, randomized trial in which patients undergoing elective 
primary hip or knee arthroplasty will be offered perioperative use of JointCOACH vs standard of 
care.  A total of 400 patients will be enrolled (200 in each group). The following outcome measures 
will be collected at the intervals specified in the Schedule of Events:  

 
 
 
Version Date: 12/19/2018 
Confidential 
Page 6 of 14 
 Demographics (Age, gender, BMI) 
 Comorbidities (Age-Adjusted Charlson Comorbidity Index) 
 Surgical details (ASA (or other comorbidity index), Length of surgery (incision to 
closure), procedure type, operative limb, surgeon) 
 Length of hospital stay and discharge disposition 
 Number of ED visits and follow-up visits within 90 days 
 Number of phone calls and on-call pages within 90 days  
 Readmissions and reoperations within 90 days 
 Patient satisfaction (VAS satisfaction and PPE-15) 
 Provider satisfaction (5-point Likert scale) 
 
4.2 Patient Population 
 
The Cleveland Clinic Orthopedic Institute practice patients from Main Campus surgeons 
(Mesko, Krebs, Greene, Kamath, Piuzzi), Lutheran Hospital surgeons (Mesko, Krebs), 
Marymount surgeons (Kamath, Piuzzi), and Medina Hospital surgeons (Greene) will be assessed 
for eligibility. 
 
Inclusion criteria 
1. Undergoing primary total hip or primary total knee arthroplasty 
2. Willing to sign an IRB approved informed consent form 
3. Have internet access or mobile access with a valid email address at the time of enrollment 
4. Above the age of 18 years  
 
Exclusion criteria 
1. Staged arthroplasty procedure within 6 months of the index procedure 

 
 
 
Version Date: 12/19/2018 
Confidential 
Page 7 of 14 
2. Abandoned email address of record (e.g. bounce of email from clinic) 
3. Planned discharge to a Skilled Nursing Facility 
 
4.3 Sample Size Calculation 
We will enroll 400 patients (200 in each group).  This sample size was estimated using 
patient reported satisfaction based on the PPE-15 questionnaire as the primary endpoint. Currently, 
it is not known what will be a clinically relevant difference so we conservatively estimated that a 
10% difference in patient satisfaction (difference in % of respondents indicating a problem on the 
PPE-15 between treatment and control groups) would be relevant.  Based on data published in a 
study by Jenkinson et al, we used a mean of 24.7% (± 7.7) for the percent of respondents across 
all PPE-15 domains that identified a problem with their experience6.  Setting alpha equal to 0.05 
and power equal to 80%, we determined that we will need 153 patients in each group.  However, 
we will enroll 200 patients in each group to account for withdrawals and non-responders.   
 
 
 

 
 
 
ersion Date: 12/19/2018 
Confidential 
Page 8 of 14 
4.4 Schedule of Events 
Evaluation 
Preop 
Intraop 
Inpatient 
D1 
D2 
D3 
D4 
D6 
D8 
D10 
D12 
W1-2 
W4-6 
D30 
D90 
Demographics 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Medical History / Comorbidities 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Surgical Details 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Discharge (LOS, disposition) 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Track Readmission / Reoperation 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
Track ED visits, office visits 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
Track calls and on-call pages 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
Adverse Events  
 
X 
X 
 
 
 
 
 
 
 
 
 
 
X 
X 
Postop Check-in Check-up 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
Recovery Goals 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
 
 
HOOS Jr / KOOS Jr 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Promise 10 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Patient Satisfaction (VAS and PPE-15) 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
Provider Satisfaction (5-point Likert) 
 
 
 
 
 
 
 
 
 
 
 
 
X 

 
 
 
Version Date: 12/19/2018 
Confidential 
Page 9 of 14 
4.5 Data Analysis Plan 
The difference in percent of respondents indicating a problem on the PPE-15 between 
treatment and control groups will be calculated as [percent of standard of care respondents 
reporting a problem, averaged across all PPE-15 domains] – [percent of JointCOACH 
respondents reporting a problem, averaged across all PPE-15 domains], such that a positive 
difference indicates that the JointCOACH group was more satisfied than the standard of care 
group, while a negative value indicates the opposite.  A superiority hypothesis test using the two-
independent sample t-test will be used to statistically evaluate the difference in the average 
satisfaction between groups.  
 
 
 
 

 
 
 
Version Date: 12/19/2018 
Confidential 
Page 10 of 14 
5. References 
1.  
Coulter A, Ellins J. Effectiveness of strategies for informing, educating, and involving 
patients. BMJ. 2007;335(7609):24-27. doi:10.1136/bmj.39246.581169.80. 
2.  
Hibbard JH, Greene J, Overton V. Patients with lower activation associated with higher 
costs; delivery systems should know their patients’ “scores”. Health Aff (Millwood). 
2013;32(2):216-222. doi:10.1377/hlthaff.2012.1064. 
3.  
Graarup J, Ferrari P, Howard LS. Patient engagement and self-management in pulmonary 
arterial hypertension. Eur Respir Rev. 2016;25(142):399-407. 
doi:10.1183/16000617.0078-2016. 
4.  
Lee CS, Bidwell JT, Paturzo M, et al. Patterns of self-care and clinical events in a cohort 
of adults with heart failure: 1 year follow-up. Heart Lung. 2018;47(1):40-46. 
doi:10.1016/j.hrtlng.2017.09.004. 
5.  
Ryu B, Kim N, Heo E, et al. Impact of an Electronic Health Record-Integrated Personal 
Health Record on Patient Participation in Health Care: Development and Randomized 
Controlled Trial of MyHealthKeeper. J Med Internet Res. 2017;19(12):e401. 
doi:10.2196/jmir.8867. 
6.  
Jenkinson C, Coulter A, Bruster S. The Picker Patient Experience Questionnaire: 
development and validation using data from in-patient surveys in five countries. Int J Qual 
Heal care  J Int Soc Qual Heal Care. 2002;14(5):353-358. 
 
 
 

 
 
 
Version Date: 12/19/2018 
Confidential 
Page 11 of 14 
6. Appendix 
6.1 Study Metrics 
Metric 
Justification  
Patient Reported satisfaction – VAS and PPE-15 
-Substantial opportunity for the Cleveland Clinic to 
differentiate itself among health systems and enhance 
revenue associated with patient satisfaction measures 
Patient utilization and compliance 
- Substantial opportunity for national exposure as related 
to national directives to drive patient engagement (See 
NCQA’s Leadership Series: Focus on Patient 
Engagement at 
http://www.qualityprofiles.org/leadership_series/patient
_engagement/index_patient_engagement.asp ) 
Physician and staff satisfaction 
- Opportunity to demonstrate clinical adoption rates and 
low barriers to implementation. 
Total 90 day post-operative cost from index date+1 
(same day) or from index date + LOS (inpatient)* 
 
*Claims submitted within 90 days must be limited to 
ICD-10 listed below (or if hospitalization due to 
ICD-10 below) in order to exclude unrelated claims. 
Joint Coach templates should be able to either prevent 
the complication, or through early detection at the clinic 
level, reduce expense through minimized emergency 
room visits and readmissions. 
 
 
30 day post-op hospitalization rate (this is a 
readmission if initially an inpatient procedure, or an 
admission if initially an outpatient procedure)* 
*Must be associated with ICD-10s listed below in 
order to exclude unrelated readmissions. 
 
30-day ED Visit Rate* 
*Must be associated with ICD-10s listed below in 
order to exclude unrelated ED visits. 
 
Number of follow up visits within 90 days 
Demonstration to physicians and practices the potential 
to improve throughput and workflow efficiency by 
minimizing the number of follow up visits required. 
Potentially preventable readmissions and 
complications identified using JointCOACH 
 
Potentially preventable admissions, events, ED visits.  
Using an approach similar to 3M’s Potentially 
Preventable Events grouping software, we will examine 
all events (ED visits, admissions, complications) for 
relation to index event, and compare this rate to prior 
year.  Data may be supplemented by Physician survey. 
http://solutions.3m.com/wps/portal/3M/en_US/Health-
Information-Systems/HIS/Products-and-
Services/Products-List-A-Z/PPR-and-PPC-Grouping-
Software/ 
 
 
 
 

 
 
 
Version Date: 12/19/2018 
Confidential 
Page 12 of 14 
6.2 ICD-10 codes for relevant metrics 
Description  
1. Must be in 1st or 2nd diagnosis and must not be chronic, or 
2. If patient is admitted, must be in 1st or 2nd diagnosis on hospital discharge. 
ICD-10 
 
Infection and inflammatory reaction due to internal prosthetic device, implant, and graft  
 
Due to unspecified implant, device, and graft 
 
Due to internal joint prosthesis 
 
Due to other internal orthopedic device, implant and graft 
 
 
T8579XA 
T8450XA 
T8460XA 
Other complications of internal prosthetic device, implant, and graft 
 
Due to unspecified implant, device, and graft 
 
Due to internal joint prosthesis 
 
Due to other internal orthopedic device, implant, and graft 
 
T859XXA 
T8481XA-
T8486XA; 
T8489XA; 
T849XXA 
 
Postoperative infection 
 
Other post-operative infection (abscess, septicemia) 
 
K6811 
T814XXA 
Disruption of wound 
 
Dehiscence of operation wound 
 
T8130XA-
T8132XA 
Infections of Skin and Subcutaneous Tissue 
 
Upper arm and forearm 
 
Leg except foot 
 
Abscess NOS, Cellulitis NOS 
 
LO3119 
LO3129 
LO390 
LO391 
 
Gastrointestinal hemorrhage 
 
Hematemesis 
 
Melena 
 
Hemorrhage of gastrointestinal tract, unspecified 
 
K920 
K921 
K922 
Hemorrhage NOS 
R58 
Venous embolism and thrombosis of deep vessels of lower extremity 
 
Of unspecified site 
I82409 
I8291 
Pulmonary embolism and infarction 
I2690 
I2692 
I2699 
T82817A, 
T82818A 
Since ED coding is often not as precise as the above, we will likely need to also have 
these below 
 
Fever unspecified 
R502 
R509 
R5081-
R5094 
R6883 
Systemic inflammatory response syndrome due to infectious process without acute organ 
dysfunction 
A419 
Severe sepsis 
R6520 
Joint Replacement DRGs 
461-462, 
469-470 
Hip and Knee specific DRGs 
466-468, 
488-489 
 
 

 
 
 
Version Date: 12/19/2018 
Confidential 
Page 13 of 14 
6.3 Success Thresholds for Study Metrics 
Metric  
Threshold 
Rationale 
Patient reported () satisfaction  
≥ 70% satisfied or very 
satisfied 
Value is consistent 
with most of the 
Medicare value based 
purchasing programs.  
70% also exceeds 
thresholds targeted by 
several other large 
health systems. 
Patient engagement 
≥ 70% of members are ≥ 60% 
engaged with the Joint Coach 
software 
 
Physician satisfaction 
> 80% physician satisfaction 
 
Total 90 day post-operative 
cost (claims submitted) from 
index date+1 (same day) or 
from index date + LOS 
(inpatient) 
 
No increase in cost during 
pilot study relative to cost 
averaged across 3 prior years 
(costs to be adjusted for 
inflation using either the 
medical care component of 
the Bureau of Labor Statistics 
Consumer Price Index, or The 
health system internal 
inflation index if available.) 
Standard inflationary 
cost adjustment in 
medical economics is 
the medical care 
component of the CPI, 
or using a 3% discount 
rate. 
30-day post-op hospitalization 
rate 
< 4% considering the UHC 
national average 
 
30-day ED visit rate 
 
 
Number of follow up visits 
within 90 days 
 
 
Potentially preventable 
admissions 
 
 
 
 
 

 
 
 
Version Date: 12/19/2018 
Confidential 
Page 14 of 14 
Provider Satisfaction Survey 
 
What is your role? 
 Surgeon      Physician Assistant      Nurse 
 
How satisfied are you with the use of JointCOACH? 
 Very Dissatisfied      Dissatisfied      Neutral      Satisfied      Very Satisfied  
 
How likely are you to recommend JointCOACH to others?   
 Very Unlikely      Unlikely      Neutral      Likely      Very Likely