Dartmouth-Hitchcock GreenCare Registry for Total Knee Replacement

Completed

• Conditions: Arthroplasty, Replacement, Knee

• Registration Number: NCT02912806
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief Summary

Evolving reimbursement policies are driving health systems to improve quality and efficiency. Transitioning to an electronic health record (EHR) provided Dartmouth-Hitchcock Medical Center (DHMC) an opportunity to redesign staff roles and care path for Total Knee Replacement (TKR). The organization implemented a coordinated team-based care delivery model that integrated real-time measurement of: (1) compliance with trusted guidelines, (2) process of Shared Decision-Making (SdM), and (3) use of Patient-Reported Outcomes (PROs). The investigators present the implementation protocol and data.

Detailed Description

Patient-reported outcome measures were completed 1 month preceding TKR and also at 1 and 12 months following surgery. The primary outcome was change in physical function from baseline to 1-year following surgery in the Physical Component Summary (PCS) of the Veterans-Rand (VR-12) Survey. Preoperative measures were: (1) general demographics (patient age, sex, height, weight, body mass index (BMI); (2) treatments tried before surgery; (3) health habits (tobacco use, alcohol use); (4) pre-existing medical conditions (Charlson score); (5) physical exam findings (knee range of motion, knee laxity); (7) lab tests (hemoglobin); and (7) radiographic measures (severity of osteoarthritis on standing x-rays). Secondary outcomes included Physical Score (PS) of the Patient Reported Outcome Measurement Information System Global Survey (PROMIS-10), knee function (Knee Osteoarthritis Outcome Score, KOOS), safety (reoperations, readmissions, emergency visits, and infection) and measures of patient experience (Clinician Group and Hospital Consumer Assessment of Healthcare Providers and Systems).

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2015-05
• Study Completion: 2016-04
• Status Verified: 2016-09
• Study First Submitted: 2016-09-20
• Study First Submitted QC: 2016-09-22
• Last Update Submitted: 2016-09-22
• Study First Posted: 2016-09-23
• Last Update Posted: 2016-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 545

Inclusion Criteria

• Scheduled TKR
• Osteoarthritis of the knee

Exclusion Criteria

• previous TKR on the affected knee
• diagnosis other than osteoarthritis
• age less than 18 years
• declined consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Health Gain as measured by the change in Physical Component Summary (PCS) Score	1-year following surgery	Health Gain from baseline to 12 months (from 300 to 400 days following the date) following surgery, as measured by the change in Physical Score based on standardized US adult population benchmarks for the VR12 survey

Secondary Outcome Measures

Name	Time	Method
ER visits after surgery	3 months	From 0 to 90 days following the date of surgery
Health Gain as measured by the change in Global Physical Health (GPH)	1-year	Health Gain from baseline to 12 months following surgery, as measured by the change in Physical Score based on standardized US adult population benchmarks for the PRIOMIS10 survey
Health Gain as measured by the change in Percentile Rank, TKR age and gender matched	1 year	Health Gain from baseline to 12 months following surgery, as measured by the change in Physical Score Percentile Rank based on age and gender-matched beta distributions for the Dartmouth TKR population, for the PRIOMIS10 or VR12 survey
Emotional Health	1 year	Mental Component Summary (MCS) Score change from baseline to 12 months following surgery, as measured by the change in Mental Score based on standardized US adult population benchmarks for the PRIOMIS10 or VR12 survey
Reoperation	3 months	From 0 to 90 days following the date of surgery
Readmission	3 months	From 0 to 90 days following the date of surgery
Infection	3 months	From 0 to 90 days following the date of surgery
Patient Satisfaction with Hospital	1 month	HCAHPS survey in 10% random subsample completed between 20 to 40 days following the date of surgery
Cost of care	3 months	Episode-based costs for 0 to 90 days following the date of surgery, and also per visit outpatient costs
Mortality	1 year
Knee Osteoarthritis Outcome Score (KOOS)	1 year	Change in KOOS score from baseline to 12 months following surgery
Length of hospital stay	Acute hospitalization	Number of days between date of admission and date of discharge
Patient Satisfaction with Surgeon	10 months	Clinician Group CAHPS survey in 10% random subsample completed between 300 to 400 days following the date of surgery
Discharge to home	Acute hospitalization	Disposition at time of discharge from acute hospitalization
Range of motion	90 days	Knee range of motion measured by a clinician between 60 and 120 days following surgery