Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Heart Failure Recorded in Primary Care, Hospital Admissions and National Mortality Registry

14. september 2015 oppdatert av: University College, London

Capture and Concordance of Heart Failure Recorded in Primary Care, Hospital Admissions and National Mortality Registry: A Cohort Study In 2.1 Million People

The main objectives of this study are i) to assess how heart failure was captured accross different linked electronic health record sources within the CALIBER program and the overlap between primary care, hospital admissions and/or the national mortality register, and ii) to assess risk factors, heart failure treatment and survival in patients, stratified by EHR source.

Studieoversikt

Status

Ukjent

Forhold

Detaljert beskrivelse

Heart failure (HF) is one of the leading causes of hospital admissions and mortality in modern healthcare systems. It can be viewed as a collective clinical syndrome of many signs and symptoms and is frequently the common endpoint of various heart diseases. Often, it is not diagnosed until it has reached a level whereby quality of life is significantly, and often irreversibly, impaired. Even though vast quantities of National Health Service (NHS) data concerning patients with heart failure are recorded, there are limited 'real world' longitudinal insights about the prognosis and consequences of HF. Although linked electronic health records cohorts such as the CALIBER program become increasingly available, for heart failure the overlap, risk factors and subsequent mortality have not been compared. Previous studies on heart failure using EHR sources have used ICD-9 or 10 codes for the identification of heart failure cases and the prevalence estimates of risk factors and comorbidity. Furthermore, the assessment of supporting information for heart failure present in electronic healthcare registries remains largely unknown. Currently, heart failure is typically inferred based on previous reports or the prescription of heart failure related medication. To strengthen heart failure case ascertainment in large electronic healthcare registries, linkages with primary care data such as what is done in CALIBER could allow more detailed insight in medical history, clinical diagnoses, anthropometric measures, health behaviour, laboratory tests, medical procedures and prescriptions.

In this study, the investigators assessed the distribution of recording, supportive medical information for heart failure diagnosis, risk factors and subsequent mortality of heart failure patients captured in linked EHR data from primary care, hospital admissions and/or death registry.

This study is part of the CALIBER (Cardiovascular disease research using linked bespoke studies and electronic records) programme funded over 5 years from the NIHR and Wellcome Trust. CALIBER has received both Ethics approval (ref 09/H0810/16) and ECC approval (ref ECC 2-06(b)/2009 CALIBER dataset).

Studietype

Observasjonsmessig

Registrering (Forventet)

100000

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • London, Storbritannia, NW1 2DA
        • Farr Institute, University College London

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

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

From 1 January 1997, all patients aged ≥18 years old, registered in CPRD practices in England consenting to data linkage, with at least one year of up-to-standard pre-study follow-up are potentially eligible.

Beskrivelse

Inclusion Criteria:

  • Patients with a coded diagnosis for heart failure in primary care or hospital admission
  • Patients with a coded diagnosis for heart failure as a cause of death in the national mortality register
  • Patients in CPRD practices which are deemed "up to standard" for more than 1 year by CPRD criteria.
  • Patients with at least one year of follow-up in the CPRD practice CPRD.

Exclusion Criteria:

  • past medical history of heart failure

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Primary care only
Patients with heart failure recorded in primary care and never hospitalized for heart failure
Primary care and secondary care
Patients with heart failure recorded in primary care with at least one record of a heart failure related hospitalization.
Secondary care only
Patients with heart failure recorded in at least one heart failure related hospitalization without a concurrent primary care record.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Venn diagram of heart failure recording by data source
Tidsramme: 13 years
Frequency and overlap of heart failure patients recorded in primary care, hospital admissions and as cause of death in the national mortality registry.
13 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Heart failure mortality
Tidsramme: 5 years
5 year heart failure cause of death following the first recorded heart failure diagnosis
5 years
Cardiovascular mortality
Tidsramme: 5 years
The 5 year cardiovascular mortality following the first recorded heart failure diagnosis.
5 years
All-cause mortality
Tidsramme: 5 years
The all cause mortality 5 years following the first recorded heart failure diagnosis
5 years

Samarbeidspartnere og etterforskere

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

Samarbeidspartnere

Etterforskere

  • Studiestol: Stefan Koudstaal, MD PhD, University College, London
  • Studieleder: Folkert W. Asselbergs, MD PhD, University College, London
  • Hovedetterforsker: Harry Hemingway, PhD, University College, London

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

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. juli 2015

Primær fullføring (Forventet)

1. desember 2015

Studiet fullført (Forventet)

1. desember 2015

Datoer for studieregistrering

Først innsendt

11. august 2015

Først innsendt som oppfylte QC-kriteriene

14. september 2015

Først lagt ut (Anslag)

16. september 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

16. september 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. september 2015

Sist bekreftet

1. juli 2015

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 14_149SK

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. .

Abonnere