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

14. september 2015 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Detaljeret 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).

Undersøgelsestype

Observationel

Tilmelding (Forventet)

100000

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2015

Primær færdiggørelse (Forventet)

1. december 2015

Studieafslutning (Forventet)

1. december 2015

Datoer for studieregistrering

Først indsendt

11. august 2015

Først indsendt, der opfyldte QC-kriterier

14. september 2015

Først opslået (Skøn)

16. september 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

16. september 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. september 2015

Sidst verificeret

1. juli 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 14_149SK

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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