Dartmouth-Hitchcock GreenCare Registry for Total Knee Replacement

Arthroplasty, Replacement, Knee Clinical Trial

— GreenCare  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02912806
• Other study ID #: CPHS23310
• Status: Completed
• Phase: N/A
• First received: September 20, 2016
• Last updated: September 22, 2016
• Start date: January 2013
• Est. completion date: April 2016

Study information

• Verified date: September 2016
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical 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). 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 545
• Est. completion date: April 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1-year following surgery	No
Secondary	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	1-year	No
Secondary	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	1 year	No
Secondary	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	1 year	No
Secondary	Knee Osteoarthritis Outcome Score (KOOS)	Change in KOOS score from baseline to 12 months following surgery	1 year	No
Secondary	Reoperation	From 0 to 90 days following the date of surgery	3 months	Yes
Secondary	Readmission	From 0 to 90 days following the date of surgery	3 months	Yes
Secondary	ER visits after surgery	From 0 to 90 days following the date of surgery	3 months	Yes
Secondary	Infection	From 0 to 90 days following the date of surgery	3 months	Yes
Secondary	Patient Satisfaction with Hospital	HCAHPS survey in 10% random subsample completed between 20 to 40 days following the date of surgery	1 month	No
Secondary	Patient Satisfaction with Surgeon	Clinician Group CAHPS survey in 10% random subsample completed between 300 to 400 days following the date of surgery	10 months	No
Secondary	Cost of care	Episode-based costs for 0 to 90 days following the date of surgery, and also per visit outpatient costs	3 months	No
Secondary	Length of hospital stay	Number of days between date of admission and date of discharge	Acute hospitalization	No
Secondary	Discharge to home	Disposition at time of discharge from acute hospitalization	Acute hospitalization	No
Secondary	Mortality		1 year	Yes
Secondary	Range of motion	Knee range of motion measured by a clinician between 60 and 120 days following surgery	90 days	No