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Dartmouth-Hitchcock GreenCare Registry for Total Knee Replacement (GreenCare)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02912806
Recruitment Status : Completed
First Posted : September 23, 2016
Last Update Posted : September 23, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Arthroplasty, Replacement, Knee Procedure: Total Knee Replacement

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).

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Study Type : Observational [Patient Registry]
Actual Enrollment : 545 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: The Dartmouth GreenCare Program: Implementation of Shared Decision Making and Patient-reported Outcomes in a Standardized Care Path for Knee Replacement
Study Start Date : January 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement


Intervention Details:
  • Procedure: Total Knee Replacement
    Primary total knee arthroplasty for knee osteoarthritis


Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients scheduling primary TKR for osteoarthritis of the knee at a regional tertiary care hospital
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02912806


Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
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Principal Investigator: Sohail K Mirza, MD, MPH Dartmouth-Hitchcock Medical Center
Additional Information:

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Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT02912806    
Other Study ID Numbers: CPHS23310
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: September 23, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The consented data that has been collected will be stripped of all identifiers and kept as a dataset appropriate for sharing with future researchers for secondary analyses. A Project Proposal form and Data Use Agreement will be required.
Keywords provided by Dartmouth-Hitchcock Medical Center:
Knee Arthroplasty
Total knee replacement
Knee osteoarthritis
Patient-Outcomes Measurement Program
Surgical Registries
Shared Decision Making
Patient Reported Outcomes
Patient Experience
Cohort Studies