An Observational Study of GP Verbal Reminders Upon Cervical Screening (VRCS)

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.

Study Overview

• Status: Completed
• Conditions: HPV-Related Cervical Carcinoma; Physician-Patient Relations
• Intervention / Treatment: Behavioral: Cervical Screening Reminder

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 724

Contacts and Locations

Study Locations

• United Kingdom
  • Greater Manchester
    • Salford, Greater Manchester, United Kingdom, M28 3DR
      • The Gill Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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: "Your cervical cancer screening is now overdue."; "The test is easy to perform and saves thousands of lives from cervical cancer every year."; "Should we book an appointment for cervical screening now so that you make sure you have it done?"Those who are seen face-to-face receive a fourth intervention:; An appointment slip is given to the patient to hand to the receptionist. This includes the patient's name and the comment, "book an appointment with practice nurse for cervical screening".	Behavioral: Cervical Screening Reminder; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uptake of Cervical Screening	The number of patients who undergo cervical screening	Up to 1 year post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to book screening	Length of time taken to undergo screening following intervention	Up to 1 year post intervention

Collaborators and Investigators

• Sponsor: Dr. Faizan Awan
• Investigators: Principal Investigator: Faizan A Awan, MBChB MRCGP, The Gill Medical Centre

Publications and helpful links

General Publications

• 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;2011(5):CD002834. doi: 10.1002/14651858.CD002834.pub2.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): February 29, 2020
• Study Completion (Actual): March 3, 2021

Study Registration Dates

• First Submitted: July 11, 2021
• First Submitted That Met QC Criteria: July 11, 2021
• First Posted (Actual): July 21, 2021

Study Record Updates

• Last Update Posted (Actual): August 12, 2021
• Last Update Submitted That Met QC Criteria: August 5, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Primary health care; Cervical Screening; Physician intervention
• Other Study ID Numbers: 298846

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The IPD will be shared with researchers who confirm the purpose of their request and are affiliated with a research organisation.
• IPD Sharing Time Frame: Immediately available for up to 10 years post-publication.
• IPD Sharing Access Criteria: Contact principal investigator via e-mail.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No