VRCS: An Observational Study of GP Verbal Reminders Upon Cervical Screening

• Sponsor: Dr. Faizan Awan (Other)
• Overall Status: Completed
• CT.gov ID: NCT04970394
• Collaborator: (none)
• Enrollment: 724
• Location: 1
• Actual Duration (Months): 48.1
• Patients Per Site Per Month: 15.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
HPV-Related Cervical Carcinoma; Physician-Patient Relations	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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 724 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Mar 1, 2017
• Actual Primary Completion Date: Feb 29, 2020
• Actual Study Completion Date: Mar 3, 2021

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Uptake of Cervical Screening [Up to 1 year post intervention]

   The number of patients who undergo cervical screening

Secondary Outcome Measures

1. Time to book screening [Up to 1 year post intervention]

   Length of time taken to undergo screening following intervention

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Gill Medical Centre	Salford	Greater Manchester	United Kingdom	M28 3DR

Sponsors and Collaborators

• Dr. Faizan Awan

Investigators

• Principal Investigator: Faizan A Awan, MBChB MRCGP, The Gill Medical Centre

Study Documents (Full-Text)

None provided.

More Information

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;(5):CD002834. doi: 10.1002/14651858.CD002834.pub2. Review. Update in: Cochrane Database Syst Rev. 2021 Sep 6;9:CD002834.

• Responsible Party: Dr. Faizan Awan, General Practitioner, The Gill Medical Centre
• ClinicalTrials.gov Identifier: NCT04970394
• Other Study ID Numbers: 298846
• First Posted: Jul 21, 2021
• Last Update Posted: Aug 12, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dr. Faizan Awan, General Practitioner, The Gill Medical Centre: Cervical Screening; Primary health care; Physician intervention

Study Results

No Results Posted as of Aug 12, 2021