Dartmouth-Hitchcock GreenCare Registry for Total Knee Replacement

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प्रायोजक

Dartmouth-Hitchcock Medical Center

नैदानिक परीक्षण: NCT02912806

BioSeek: NCT02912806

कीवर्ड

सार

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.

विवरण

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).

खजूर

अंतिम सत्यापित:	08/31/2016
पहले प्रस्तुत किया गया:	09/19/2016
अनुमानित नामांकन प्रस्तुत किया गया:	09/21/2016
पहले पोस्ट किया गया:	09/22/2016
अंतिम अद्यतन प्रस्तुत किया:	09/21/2016
अंतिम अद्यतन पोस्ट:	09/22/2016
वास्तविक अध्ययन प्रारंभ दिनांक:	12/31/2012
अनुमानित प्राथमिक समापन तिथि:	04/30/2015
अनुमानित अध्ययन पूर्णता तिथि:	03/31/2016

स्थिति या रोग

Arthroplasty, Replacement, Knee

हस्तक्षेप / उपचार

Procedure: Total Knee Replacement

चरण

पात्रता मापदंड

युग अध्ययन के लिए पात्र	18 Years सेवा 18 Years
सेक्स अध्ययन के लिए पात्र	All
नमूनाकरण विधि	Non-Probability Sample
स्वस्थ स्वयंसेवकों को स्वीकार करता है	हाँ
मानदंड	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

परिणाम

प्राथमिक परिणाम उपाय

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

माध्यमिक परिणाम उपाय

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

Change in KOOS score from baseline to 12 months following surgery

5. Reoperation [3 months]

From 0 to 90 days following the date of surgery

6. Readmission [3 months]

From 0 to 90 days following the date of surgery

7. ER visits after surgery [3 months]

From 0 to 90 days following the date of surgery

8. Infection [3 months]

From 0 to 90 days following the date of surgery

9. Patient Satisfaction with Hospital [1 month]

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

10. Patient Satisfaction with Surgeon [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 [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 [Acute hospitalization]

Number of days between date of admission and date of discharge

13. Discharge to home [Acute hospitalization]

Disposition at time of discharge from acute hospitalization

14. Mortality [1 year]

15. Range of motion [90 days]

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

Dartmouth-Hitchcock GreenCare Registry for Total Knee Replacement

कीवर्ड

निकोटीन

osteoarthritis

सार

विवरण

खजूर

स्थिति या रोग

हस्तक्षेप / उपचार

चरण

पात्रता मापदंड

परिणाम

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