- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02912806
Dartmouth-Hitchcock GreenCare Registry for Total Knee Replacement (GreenCare)
September 22, 2016 updated by: Dartmouth-Hitchcock Medical Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
545
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients scheduling primary TKR for osteoarthritis of the knee at a regional tertiary care hospital
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
1-year following surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mortality
Time Frame: 1 year
|
1 year
|
|
|
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
|
1-year
|
|
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
|
1 year
|
|
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
|
1 year
|
|
Knee Osteoarthritis Outcome Score (KOOS)
Time Frame: 1 year
|
Change in KOOS score from baseline to 12 months following surgery
|
1 year
|
|
Reoperation
Time Frame: 3 months
|
From 0 to 90 days following the date of surgery
|
3 months
|
|
Readmission
Time Frame: 3 months
|
From 0 to 90 days following the date of surgery
|
3 months
|
|
ER visits after surgery
Time Frame: 3 months
|
From 0 to 90 days following the date of surgery
|
3 months
|
|
Infection
Time Frame: 3 months
|
From 0 to 90 days following the date of surgery
|
3 months
|
|
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
|
1 month
|
|
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
|
10 months
|
|
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
|
3 months
|
|
Length of hospital stay
Time Frame: Acute hospitalization
|
Number of days between date of admission and date of discharge
|
Acute hospitalization
|
|
Discharge to home
Time Frame: Acute hospitalization
|
Disposition at time of discharge from acute hospitalization
|
Acute hospitalization
|
|
Range of motion
Time Frame: 90 days
|
Knee range of motion measured by a clinician between 60 and 120 days following surgery
|
90 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sohail K Mirza, MD, MPH, Dartmouth-Hitchcock Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
April 1, 2016
Study Registration Dates
First Submitted
September 20, 2016
First Submitted That Met QC Criteria
September 22, 2016
First Posted (Estimate)
September 23, 2016
Study Record Updates
Last Update Posted (Estimate)
September 23, 2016
Last Update Submitted That Met QC Criteria
September 22, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CPHS23310
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD 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.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.