NCT03296566

The SAFE Study: Satisfaction and Adherence to Follow-Up With Colposcopy Exams

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 297 (actual)
• Sponsor: University of British Columbia · Academic / Other
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This study is intended to improve the patient experience of communication of colposcopy results and follow-up recommendations to patients. Current practice involves results being forwarded from the colposcopy clinic to the family or referring physician who then informs the patient. We are testing an intervention informed by focus groups in which a trained colposcopy nurse (patient liaison) directly contacts patients with their results and follow-up recommendations while providing education and support. We will examine whether this intervention improves patient satisfaction, reduces anxiety, and improves rates of adherence to follow-up and treatment appointments compared to the current practice.

Detailed description

Cervical cancer is the second most commonly diagnosed cancer and third leading cause of cancer death in women worldwide. Pre-cancerous cells can be detected with regular Pap smear screening and diagnosed and treated with colposcopy. This process is limited by patient adherence to the follow-up and treatment recommendations. Currently at Vancouver General Hospital (VGH), the largest colposcopy clinic in the province, results are forwarded from the colposcopy clinic to the family or referring physician who informs patients of results and recommendations. Inefficiencies or errors in this step may cause patient dissatisfaction, missed appointments, increased costs, and compromise patient outcomes. The primary objective of this study is to examine whether having a trained colposcopy nurse directly contact patients with their results and follow-up recommendations while providing education and support will improve patient satisfaction and reduce anxiety, with the secondary aim being to assess the clinical effectiveness of this intervention in improving rates of adherence to follow-up and treatment appointments and potentially long-term clinical outcomes. The first phase of the study involves patient focus groups that will be interviewed about what elements of a patient liaison interaction are most important (separate Ethics submission). This information will inform the development of the patient liaison role and approaches to patient interaction to be utilized in the intervention in the second phase. The second phase will entail a randomized controlled trial comparing patient anxiety, satisfaction and adherence to follow-up between a control group (current practice) versus the intervention group exposed to the patient liaison at the VGH Colposcopy Clinic. For the primary aim, a questionnaire containing items pertaining to patient anxiety and satisfaction with their experience of receiving their colposcopy results will be administered both to the intervention and control groups and the mean scores pertaining to anxiety and satisfaction will be compared using two-tailed t-tests. For the secondary aim, a chart review at 6-12 months following the initial colposcopy visit will examine the rates of compliance with the recommended follow-up or treatment visits and histologic diagnoses, and comparisons will be sought between the intervention and control groups using z-score test.

Conditions

• Uterine Cervical Dysplasia
• Uterine Cervix Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Patient Liaison	An experienced colposcopy nurse will contact participants once the colposcopists complete the final colposcopy report. The colposcopy report will inform the referring provider that these patients will be informed of the results. The colposcopy nurse will provide an explanation of the colposcopy results and subsequent follow-up or treatment recommendations, be available to answer patient questions (within her scope), offer educational or support resources to patients. She will forward any patient questions beyond her scope to the patient's colposcopist who may then provide answers to the patient liaison or to the patient directly depending on the complexity and nature of the question.

Timeline

• Start date: 2017-07-13
• Primary completion: 2018-06-30
• Completion: 2018-06-30
• First posted: 2017-09-28
• Last updated: 2020-04-24
• Results posted: 2020-04-24

Locations

1 site across 1 country: Canada