Brief Title
The SAFE Study: Satisfaction and Adherence to Follow-Up With Colposcopy Exams
Official Title
The SAFE Study: Satisfaction and Adherence to Follow-Up With Colposcopy Exams
Brief 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.
Study Type
Interventional
Primary Outcome
Anxiety
Secondary Outcome
Patient Knowledge of Own Colposcopy Diagnosis
Condition
Uterine Cervical Dysplasia
Intervention
Patient Liaison
Study Arms / Comparison Groups
Patient Liaison Intervention
Description: The participants randomized to the intervention group will be exposed to the patient liaison in receiving their colposcopy report results and recommendations. Rather than receive results from their referring/family physician, an experienced colposcopy nurse will contact participants once the colposcopists complete the final colposcopy report. 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Behavioral
Estimated Enrollment
297
Start Date
July 13, 2017
Completion Date
June 30, 2018
Primary Completion Date
June 30, 2018
Eligibility Criteria
Inclusion Criteria:
1. Must be 19 years of age or older
2. Must be patients presenting for an initial visit at the VGH Colposcopy Clinic
Exclusion Criteria:
1. Inability to speak conversational English- required to complete the questionnaire as
well as provide informed consent to participate
2. Inability or refusal to provide consent
3. Pregnant - pregnant women do not usually have biopsies and their subsequent care may
be much different than non-pregnant patients
4. Do not have a family physician or referring physician who will provide continuity of
care following colposcopy - these patients do not have the option of getting results
from a family or referring physician, so they would bias results.
Gender
Female
Ages
19 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Marette Lee, MD/MPH/FRCSC, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT03296566
Organization ID
H16-03194
Responsible Party
Principal Investigator
Study Sponsor
University of British Columbia
Collaborators
British Columbia Cancer Agency
Study Sponsor
Marette Lee, MD/MPH/FRCSC, Principal Investigator, University of British Columbia
Verification Date
April 2020