Clinical trial NCT04970394: An Observational Study of GP Verbal Reminders Upon Cervical Screening
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HPV-Related Cervical Carcinoma
Physician-Patient Relations
Keywords: Cervical Screening
Primary health care
Physician intervention
Lead sponsor: The Gill Medical Centre
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 724
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Uptake of Cervical Screening
timeFrame: Up to 1 year post intervention
Secondary outcomes:
measure: Time to book screening
timeFrame: Up to 1 year post intervention
Other outcomes:
Locations:
city: Salford
country: United Kingdom
facility: The Gill Medical Centre
state: Greater Manchester
Study officials:
affiliation: The Gill Medical Centre
name: Faizan A Awan, MBChB MRCGP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.