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Arthroplasty, Replacement, KneeGreenCareNCT02912806

Dartmouth-Hitchcock GreenCare Registry for Total Knee Replacement

An observational study of Arthroplasty, Replacement, Knee, run by Dartmouth-Hitchcock Medical Center.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Arthroplasty, Replacement, Knee
What is being tested?
Total Knee Replacement
Type of treatment
Surgery or procedure
How many people
545 participants
Where
No sites listed yet
Study dates
Jan 2013to Apr 2016
How long will I take part?
1 Year
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients scheduling primary TKR for osteoarthritis of the knee at a regional tertiary care hospital

Who may be able to join

  • Scheduled TKR
  • Osteoarthritis of the knee

Who cannot join

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

About this study

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

Read the 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).

Being tested
Total Knee Replacement
Keywords
Knee Arthroplasty, Total knee replacement, Knee osteoarthritis, Patient-Outcomes Measurement Program, Surgical Registries, Shared Decision Making, Patient Reported Outcomes, Patient Experience, Cohort Studies
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Total Knee ReplacementProcedure or surgery

    Primary total knee arthroplasty for knee osteoarthritis

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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

    Measured: 1-year following surgery

Secondary outcomes (15)

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

    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

    Measured: 1-year

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

    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

    Measured: 1 year

  3. Emotional Health

    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

    Measured: 1 year

  4. Knee Osteoarthritis Outcome Score (KOOS)

    Change in KOOS score from baseline to 12 months following surgery

    Measured: 1 year

  5. Reoperation

    From 0 to 90 days following the date of surgery

    Measured: 3 months

  6. Readmission

    From 0 to 90 days following the date of surgery

    Measured: 3 months

  7. ER visits after surgery

    From 0 to 90 days following the date of surgery

    Measured: 3 months

  8. Infection

    From 0 to 90 days following the date of surgery

    Measured: 3 months

  9. Patient Satisfaction with Hospital

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

    Measured: 1 month

  10. Patient Satisfaction with Surgeon

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

    Measured: 10 months

  11. Cost of care

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

    Measured: 3 months

  12. Length of hospital stay

    Number of days between date of admission and date of discharge

    Measured: Acute hospitalization

  13. Discharge to home

    Disposition at time of discharge from acute hospitalization

    Measured: Acute hospitalization

  14. Mortality

    Measured: 1 year

  15. Range of motion

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

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2016 (estimated)
  2. Study startJan 2013
  3. Primary completionMay 2015
  4. Study completionApr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
545 participants (actual)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT02912806
Sponsor's protocol ID
CPHS23310
Acronym
GreenCare
Status last verified
Sep 2016
First submitted
20 Sep 2016
Last updated
23 Sep 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Arthroplasty, Replacement, Knee, run by Dartmouth-Hitchcock Medical Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health Gain as measured by the change in Physical Component Summary (PCS) Score (time frame: 1-year following surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02912806.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2016.

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