An Observational Study of GP Verbal Reminders Upon Cervical Screening (VRCS)
5. august 2021 opdateret af: Dr. Faizan Awan
Three-year Prospective Cohort Study of the Effectiveness of Physician Reminders on Cervical Screening Uptake Amongst Non Responders in a UK Primary Care Setting
Cervical cancer screening is offered to all women in the United Kingdom (UK) between the ages of 24.5 and 64 years of age.
The majority of screening is performed in primary care and the rate remains stubbornly below 80%, despite an automated national invitation system.
This study is designed to assess the effectiveness of a physician invitation during a telephone or face-to-face primary care appointment upon non responders of automated invitations, to increase the uptake of cervical screening.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
It is estimated that between 800 and 2,000 deaths a year are now prevented due to the effectiveness of the UK's national cervical screening programme and mortality rates have dropped by over 75% since the 1970s.
These statistics corroborate the importance of the screening programme in reducing mortality from cervical cancer.
Cervical screening rates in the UK remains stubbornly below 80% and interventions are needed to attract the 20% who are missing out on screening.
This prospective observational study is designed to measure the impact of a physician intervention in a usual healthcare environment, amongst a heterogeneous patient population to yield replicable real-world results.
The intervention arm will receive a physician intervention to inform them of their overdue screening status, remind them of the importance of cervical screening and guide them to book a screening appointment.
The screening rate in the intervention arm will be compared to a control made up of patients seen by other clinicians and receiving unstructured reminders.
The results will assist physicians in deciding whether a structured intervention is anymore effective than the unstructured advice currently given at improving screening rates in the non responder population.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
724
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Greater Manchester
-
Salford, Greater Manchester, Det Forenede Kongerige, M28 3DR
- The Gill Medical Centre
-
-
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
25 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Patients registered at the Gill Medical Centre, who have a cervix, are eligible for cervical screening and have been non responders to the automated national invitation.
These patients are opportunistically recruited when they are consulted by the principal investigator.
Beskrivelse
Inclusion Criteria:
- Registered patient with a cervix
- Non responder to cervical screening invitation
Exclusion Criteria:
- Incorrectly reminded i. Coding errors ii. Human error
- Temporary patients i. Did not remain registered for minimum of 6 months following intervention
- Screening refusal
- Inappropriate to include i. Terminal illness ii. Prolonged hospitalisation iii. Death due to non-cervical cancer attributable cause
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 |
Intervention / Behandling |
|---|---|
|
Intervention
The principal investigator reviews the medical notes of all individuals they consult over a period of three years to check if they are non responders. If confirmed as non responder, they receive a three-step verbal intervention:
|
Verbal reminder and if seen face-to-face, a written appointment booking slip.
|
|
Control
The control group receives standard unstructured reminders regarding their overdue status from any of the 6 other clinicians during appointments and / or reminder letters from the administration team.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Uptake of Cervical Screening
Tidsramme: Up to 1 year post intervention
|
The number of patients who undergo cervical screening
|
Up to 1 year post intervention
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Time to book screening
Tidsramme: Up to 1 year post intervention
|
Length of time taken to undergo screening following intervention
|
Up to 1 year post intervention
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Faizan A Awan, MBChB MRCGP, The Gill Medical Centre
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 (Faktiske)
1. marts 2017
Primær færdiggørelse (Faktiske)
29. februar 2020
Studieafslutning (Faktiske)
3. marts 2021
Datoer for studieregistrering
Først indsendt
11. juli 2021
Først indsendt, der opfyldte QC-kriterier
11. juli 2021
Først opslået (Faktiske)
21. juli 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. august 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. august 2021
Sidst verificeret
1. august 2021
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 298846
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
The IPD will be shared with researchers who confirm the purpose of their request and are affiliated with a research organisation.
IPD-delingstidsramme
Immediately available for up to 10 years post-publication.
IPD-delingsadgangskriterier
Contact principal investigator via e-mail.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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 .