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

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

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.

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