An Observational Study of GP Verbal Reminders Upon Cervical Screening

NCT ID: NCT04970394

Last Updated: 2021-08-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 724 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2021-03-03

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.

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.

Conditions

HPV-Related Cervical Carcinoma; Physician-Patient Relations

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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:

1. "Your cervical cancer screening is now overdue."

2. "The test is easy to perform and saves thousands of lives from cervical cancer every year."

3. "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:

4. 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".

Cervical Screening Reminder

Intervention Type: BEHAVIORAL

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.

No interventions assigned to this group

Interventions

Cervical Screening Reminder

Verbal reminder and if seen face-to-face, a written appointment booking slip.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Dr. Faizan Awan

OTHER

Sponsor Role: lead

Responsible Party

Dr. Faizan Awan

General Practitioner

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Faizan A Awan, MBChB MRCGP

Role: PRINCIPAL_INVESTIGATOR

The Gill Medical Centre

Locations

The Gill Medical Centre

Salford, Greater Manchester, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 21563135 (View on PubMed)

Other Identifiers

298846

Identifier Type: -

Identifier Source: org_study_id