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

 
 
 
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Improvement of Patient Satisfaction and Overall Outcomes Using HealthLoop 
  
 
 
NCT03481595 
07/30/2019 
 
 
 

 
 
 
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Introduction and Background: 
The Problem 
• 
Health systems invest significant resources in their efforts to improve quality and reduce 
costs.  The patient is often left out of this equation. 
• 
Studies have shown that when patients are engaged, they take increased responsibility for 
their own health, and play more active roles in prevention. 
• 
Because physicians have strong relationships with their patients, they are in the best position 
to encourage patient engagement.  However, physicians need frictionless tools with minimal 
implementation barriers in order to facilitate this relationship during follow-up. 
Patient engagement has been referred to as the next blockbuster drug, and increasing evidence 
demonstrates that highly engaged patients experience improved outcomes as well as reductions in 
complications, readmissions, and total costs of care than patients who are not actively involved in his/her 
care.  While these engagement-related outcomes have been shown in primary care, preventive care, and 
mental health specialties, relatively little has been done to explore this relationship in orthopedics.  An 
estimated $1.5 billion is spent annually in the US on readmissions following orthopaedic procedures, 
highlighting the opportunity to impact and improve orthopaedic outcomes.  While some readmissions are 
planned and/or unavoidable, many can be attributed to patient health status, poor discharge planning, 
and non-optimized care coordination.   
GetWell Loop is a SaaS platform that allows physicians to monitor signs and symptoms, and communicate 
with patients during the postoperative recovery process. The platform enables doctors to identify patients 
at risk of decline in the follow up period. Patients are engaged through mobile and web-based surveys, 
reminders, and information personalized to the patient’s specific condition or treatment plan. The 
company’s platform also collects patients’ feedbacks and monitors status against expected progress. 
Alerts are sent to physicians or providers about patients who are at risk of treatment failures, 
complications, or hospital readmissions.  Physicians are informed if patients are trending toward an 
adverse outcome based on the patient’s responses. Along with helping to prevent readmissions, GetWell 
Loop can also help institutions collect patient-reported outcomes (PROs) data, which can be used to 
evaluate and improve quality measures. 
GetWell Loop and the Cleveland Clinic are interested in collaborating on a clinical pilot study to 
demonstrate that high patient engagement leads to enhanced pre-operative preparation potentially 
reducing length of stay (LOS), readmissions / reoperations, discharge disposition to home rather than 
another facility, reduced need for in-person follow up, increased patient (and provider) satisfaction, and 
increased satisfaction survey completion rates after elective primary hip and knee arthroplasty (THA and 
TKA).  These improvements can translate on higher financial savings through the episode especially in light 
of the alternative payment models. 
Specific Aims: GetWell Loop is currently used by orthopedic groups around the country, and is believed 
to improve peri-operative outcomes after THA and TKA and mitigate 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 post-operative reporting directly to the clinical team, and 4. 

 
 
 
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Detecting impending post-operative complications early, enabling timely intervention and preventing 
avoidable complications and readmissions.   
The specific aims of this proposal are to: 
1. 
Measure the impact of using GetWell Loop on patient (and provider) satisfaction 
2. 
Understand the degree to which high post-operative engagement reduces the need for 
in-person or telephone follow up appointment time 
a. 
Does the use of GetWell Loop lead to fewer potentially avoidable healthcare 
utilization encounters such as Emergency Department and hospital visits 
(including readmissions and reoperations)? 
b. 
Does utilizing GetWell Loop improve clinical workflow by minimizing telephone 
calls and thereby offloading support staff, allowing them to be more efficient? 
c. 
Does utilizing GetWell Loop 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 GetWell Loop allow the practice to identify patients whose in-
person follow up needs are minimal, thereby freeing new referrals slots and 
enhancing same-day access? 
e. 
Does GetWell Loop improve the throughput of patients by eliminating 
unnecessary follow-up appointments? 
3. 
Measure length of stay, discharge disposition (home versus extended care facility) and 
90 days readmission and reoperation rates 
a. 
Does the early detection of adverse signs/symptoms that develop between 
clinical encounters result in earlier intervention that thereby reduces 
readmission and reoperations? 
b. 
Do Patient Reported Outcomes (PROs), collected at intervals between clinical 
encounters, provide useful information which facilitates the detections of post-
acute complications prior to the next clinical encounter? 
c. 
Does patient adherence to instructions as well as recommended activity levels, 
captured through continuous activity monitoring such as the Jawbone Up Band 
(a wristband capable of measuring activity), predict time to recovery, functional 
outcomes, and potential failure rates? (optional) 
4. 
Evaluate the financial impact of GetWell Loop in the episode of care 
 

 
 
 
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Methods: The study design is a prospective randomized trial in which patients undergoing selected hip 
and knee orthopedic procedures will be offered peri-operative use of GetWell Loop vs standard care.  
Approximately 300 patients will be enrolled (150 in each group). 
Phase 1: 6 month run-in with 9 month follow (total of 12 month long study). Will collect the following 
outcome measures:  
 
Demographics (Age, gender, BMI) 
 
Comorbidities 
 
Surgery details (Length of surgery, laterality, surgeon) 
 
LOS and discharge disposition 
 
Number/length of follow up visits within 90 days (in person and telephone) 
 
90 days readmission and reoperations 
 
Patient and provider satisfaction survey completion rates 
 
Patient satisfaction (VAS scale and PPE-15) 
Phase 2: 3 months for statistical analysis and writing manuscript. 
 
Study Participants 
A. Patients – Total Hip and Total Knee Arthroplasty patients treated at Avon Hospital 
a. Inclusion criteria 
i. Primary THA or TKA patient 
ii. Personal consent to participate 
iii. Have internet access or mobile access with a valid email address at the time of 
enrollment 
iv. Above the age of 18 and are capable of consent 
v. English speaking patient 
b. Exclusion criteria 
i. Staged arthroplasty procedure within 6 months of the index procedure 
ii. Abandoned email address of record (e.g. bounce of email from clinic). If so, then 
data may be censored in the pilot analysis 
iii. Less than 14 days until scheduled surgery 

 
 
 
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iv. Outpatient surgery 
 
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 GetWell Loop respondents reporting a problem, 
averaged across all PPE-15 domains], such that a positive difference indicates that the GetWell Loop 
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.  All other outcomes will be analyzed 
using chi-square tests for categorical variables and t-tests for continuous variables. Regression analysis 
will be conducted for multivariate analysis. 
 
Schedule of Events 
Evaluation 
History 
/ PreOp 
IntraOp 
90 days postop 
(Chart Review) 
90 days 
postop 
(survey) 
1 year             
(study completion) 
Demographics 
X 
      
 
      
 
Medical 
History/Comorbidities 
X 
      
 
      
 
Surgical Details 
      
X 
 
      
 
Discharge (LOS, disposition) 
 
 
X 
 
 
Track 
Readmission/Reoperation 
 
 
 
X 
 
Track ED visits, office visits 
 
 
 
X 
 
Track calls and on-call pages 
 
 
 
X 
 
Adverse Events  
 
 
X 
X 
 
Patient Satisfaction 
VAS and PPE-15 
      
      
 
X 
 
Provider Satisfaction Survey 
      
      
 
 
X 
 
 

 
 
 
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Study Metrics 
Metric 
Justification  
Patient satisfaction 
VAS and PPE-15 (attached) 
-Substantial opportunity for the Cleveland Clinic to 
differentiate itself among health systems and 
enhance revenue associated with patient 
satisfaction measures 
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-10s listed below (or to 
hospitalization due to ICD-10s below) in order 
to exclude unrelated claims. 
GetWell Loop 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. 
 
 
90 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. 
 
90-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 
Potentially preventable admissions, events, ED 
visits.  Using an approach similar to 3M’s 

 
 
 
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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/H
ealth-Information-Systems/HIS/Products-and-
Services/Products-List-A-Z/PPR-and-PPC-Grouping-
Software/ 
 
 
  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 
 

 
 
 
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 
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 
 
 

 
 
 
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