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Dartmouth-Hitchcock GreenCare Registry for Total Knee Replacement (GreenCare)

22. september 2016 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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).

Studietype

Observasjonsmessig

Registrering (Faktiske)

545

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Kohort
  • Tidsperspektiver: Potensielle

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Health Gain as measured by the change in Physical Component Summary (PCS) Score
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Dødelighet
Tidsramme: 1 år
1 år
Health Gain as measured by the change in Global Physical Health (GPH)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 1 year
Change in KOOS score from baseline to 12 months following surgery
1 year
Reoperation
Tidsramme: 3 months
From 0 to 90 days following the date of surgery
3 months
Readmission
Tidsramme: 3 months
From 0 to 90 days following the date of surgery
3 months
ER visits after surgery
Tidsramme: 3 months
From 0 to 90 days following the date of surgery
3 months
Infection
Tidsramme: 3 months
From 0 to 90 days following the date of surgery
3 months
Patient Satisfaction with Hospital
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Acute hospitalization
Number of days between date of admission and date of discharge
Acute hospitalization
Discharge to home
Tidsramme: Acute hospitalization
Disposition at time of discharge from acute hospitalization
Acute hospitalization
Range of motion
Tidsramme: 90 days
Knee range of motion measured by a clinician between 60 and 120 days following surgery
90 days

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Dartmouth-Hitchcock Medical Center

Etterforskere

  • Hovedetterforsker: Sohail K Mirza, MD, MPH, Dartmouth-Hitchcock Medical Center

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2013

Primær fullføring (Faktiske)

1. mai 2015

Studiet fullført (Faktiske)

1. april 2016

Datoer for studieregistrering

Først innsendt

20. september 2016

Først innsendt som oppfylte QC-kriteriene

22. september 2016

Først lagt ut (Anslag)

23. september 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

23. september 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. september 2016

Sist bekreftet

1. september 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • CPHS23310

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Ja

IPD-planbeskrivelse

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.

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

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Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

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