An Observational Study of GP Verbal Reminders Upon Cervical Screening

HPV-Related Cervical Carcinoma Clinical Trial

— VRCS  

Official title:

Three-year Prospective Cohort Study of the Effectiveness of Physician Reminders on Cervical Screening Uptake Amongst Non Responders in a UK Primary Care Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04970394
• Other study ID #: 298846
• Status: Completed
• Start date: March 1, 2017
• Est. completion date: March 3, 2021

Study information

• Verified date: August 2021
• Source: The Gill Medical Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 724
• Est. completion date: March 3, 2021
• Est. primary completion date: February 29, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• HPV-Related Cervical Carcinoma
• Physician-Patient Relations

Intervention

Behavioral:
• Cervical Screening Reminder
Verbal reminder and if seen face-to-face, a written appointment booking slip.

Locations

Country	Name	City	State
United Kingdom	The Gill Medical Centre	Salford	Greater Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Faizan Awan

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Everett T, Bryant A, Griffin MF, Martin-Hirsch PP, Forbes CA, Jepson RG. Interventions targeted at women to encourage the uptake of cervical screening. Cochrane Database Syst Rev. 2011 May 11;(5):CD002834. doi: 10.1002/14651858.CD002834.pub2. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uptake of Cervical Screening	The number of patients who undergo cervical screening	Up to 1 year post intervention
Secondary	Time to book screening	Length of time taken to undergo screening following intervention	Up to 1 year post intervention