Skip to main content
OpenTrials
Completed

NCT Number: NCT02912806

Dartmouth-Hitchcock GreenCare Registry for Total Knee Replacement

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Arthroplasty, Replacement, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Total Knee Replacement

Procedure

Primary total knee arthroplasty for knee osteoarthritis

Primary outcomes

  1. Health Gain as measured by the change in Physical Component Summary (PCS) Score

    Time frame: 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 outcomes

  1. Health Gain as measured by the change in Global Physical Health (GPH)

    Time frame: 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

  2. Health Gain as measured by the change in Percentile Rank, TKR age and gender matched

    Time frame: 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

  3. Emotional Health

    Time frame: 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

  4. Knee Osteoarthritis Outcome Score (KOOS)

    Time frame: 1 year

    Change in KOOS score from baseline to 12 months following surgery

  5. Reoperation

    Time frame: 3 months

    From 0 to 90 days following the date of surgery

  6. Readmission

    Time frame: 3 months

    From 0 to 90 days following the date of surgery

  7. ER visits after surgery

    Time frame: 3 months

    From 0 to 90 days following the date of surgery

  8. Infection

    Time frame: 3 months

    From 0 to 90 days following the date of surgery

  9. Patient Satisfaction with Hospital

    Time frame: 1 month

    HCAHPS survey in 10% random subsample completed between 20 to 40 days following the date of surgery

  10. Patient Satisfaction with Surgeon

    Time frame: 10 months

    Clinician Group CAHPS survey in 10% random subsample completed between 300 to 400 days following the date of surgery

  11. Cost of care

    Time frame: 3 months

    Episode-based costs for 0 to 90 days following the date of surgery, and also per visit outpatient costs

  12. Length of hospital stay

    Time frame: Acute hospitalization

    Number of days between date of admission and date of discharge

  13. Discharge to home

    Time frame: Acute hospitalization

    Disposition at time of discharge from acute hospitalization

  14. Mortality

    Time frame: 1 year

  15. Range of motion

    Time frame: 90 days

    Knee range of motion measured by a clinician between 60 and 120 days following surgery

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Official study title

The Dartmouth GreenCare Program: Implementation of Shared Decision Making and Patient-reported Outcomes in a Standardized Care Path for Knee Replacement

Acronym: GreenCare

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Sep 23, 2016
Registry last updated
Sep 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.