Clinical trial NCT02912806: Dartmouth-Hitchcock GreenCare Registry for Total Knee Replacement
Official title: The Dartmouth GreenCare Program: Implementation of Shared Decision Making and Patient-reported Outcomes in a Standardized Care Path for Knee Replacement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthroplasty, Replacement, Knee
Keywords: Knee Arthroplasty
Total knee replacement
Knee osteoarthritis
Patient-Outcomes Measurement Program
Surgical Registries
Shared Decision Making
Patient Reported Outcomes
Patient Experience
Cohort Studies
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2016-09-23
Enrollment: 545
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduling primary TKR for osteoarthritis of the knee at a regional tertiary care hospital

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).

Eligibility criteria: 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

Primary outcomes:
measure: Health Gain as measured by the change in Physical Component Summary (PCS) Score
timeFrame: 1-year following surgery
Secondary outcomes:
measure: Health Gain as measured by the change in Global Physical Health (GPH)
timeFrame: 1-year
measure: Health Gain as measured by the change in Percentile Rank, TKR age and gender matched
timeFrame: 1 year
measure: Emotional Health
timeFrame: 1 year
measure: Knee Osteoarthritis Outcome Score (KOOS)
timeFrame: 1 year
measure: Reoperation
timeFrame: 3 months
measure: Readmission
timeFrame: 3 months
measure: ER visits after surgery
timeFrame: 3 months
measure: Infection
timeFrame: 3 months
measure: Patient Satisfaction with Hospital
timeFrame: 1 month
measure: Patient Satisfaction with Surgeon
timeFrame: 10 months
measure: Cost of care
timeFrame: 3 months
measure: Length of hospital stay
timeFrame: Acute hospitalization
measure: Discharge to home
timeFrame: Acute hospitalization
measure: Mortality
timeFrame: 1 year
measure: Range of motion
timeFrame: 90 days
Other outcomes:
Locations:
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Sohail K Mirza, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: