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

Not Applicable

Completed

• Conditions: Uterine Cervical Dysplasia; Uterine Cervix Cancer
• Interventions: Behavioral: Patient Liaison

• Registration Number: NCT03296566
• Lead Sponsor: University of British Columbia

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 Timeline

• Study Start: 2017-07-13
• Study First Submitted: 2017-07-20
• Study First Submitted QC: 2017-09-25
• Study First Posted: 2017-09-28
• Primary Completion: 2018-06-30
• Study Completion: 2018-06-30
• Results First Submitted: 2019-05-15
• Status Verified: 2020-04
• Results First Submitted QC: 2020-04-10
• Last Update Submitted: 2020-04-10
• Results First Posted: 2020-04-24
• Last Update Posted: 2020-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 297

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient Liaison Intervention	Patient Liaison	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.

Primary Outcome Measures

Name	Time	Method
Anxiety	To be collected by questionnaire in 4-6 weeks following colposcopy visit	Mean state anxiety scores as measured by the State Trait Anxiety Inventory (STAI) State Subscale. The STAI has 40 items with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. Responses for the State Anxiety scale assess intensity of current feelings from 1-4 "at this moment": 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. Item scores are added to obtain subtest total scores and for anxiety-present items, a higher score suggests higher anxiety. Scoring is reversed for anxiety-absent items (items in which a higher score suggests lower anxiety). Range of scores for the subscale is 20-80 with a higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms for the State Anxiety scale.
Quantitative Satisfaction With Colposcopy Visit Experience Including Interactions With Colposcopy Professionals	To be collected by questionnaire in 4-6 weeks following colposcopy visit	Patient satisfaction scores as measured by items in the questionnaire drawn from the Visit Specific Satisfaction Instrument (VSQ-9) Inventory. The VSQ-9 is a 9 item survey that measures patient satisfaction with access to primary care, with the direct interaction with the physician, and with the visit overall on a scale ranging from 1 (poor) to 5 (excellent). To score the VSQ-9, responses from each individual are transformed linearly to a 0 to 100 scale, with 100 corresponding to "excellent" and 0 corresponding to "poor" (0= Poor, 25= Fair, 50= Good, 75= Very Good, 100= Excellent). The 9 responses are then averaged together to create a VSQ-9 overall score for each person, again with 100 being the best evaluation and 0 the poorest.
Satisfaction With Colposcopy Information and Diagnosis Education	To be collected by questionnaire in 4-6 weeks following colposcopy visit	Satisfaction with information and education received regarding colposcopy, patient diagnosis and follow-up recommendations measured by questionnaire items that measure these factors (PSQ-18 Inventory). This inventory contains 18 items assessing each of the 7 dimensions of satisfaction with medical care (general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor, accessibility and convenience). Each item is scored from 1-5. Some PSQ-18 items are worded so that agreement reflects satisfaction with medical care, whereas other items are worded so that agreement reflects dissatisfaction with medical care. All items all scored so that high scores reflect satisfaction with medical care. All items are then summed; sum score of all items may range from 18 to 90 points, where 18 points is the poorest evaluation and 90 points the best.

Secondary Outcome Measures

Name	Time	Method
Adherence to Colposcopy Treatment and Follow-up Instructions	6 months	Percentage of patients who attended follow-up at the colposcopy clinic
Patient Knowledge of Own Colposcopy Diagnosis	To be collected by questionnaire in 4-6 weeks following colposcopy visit	The percent of patients who correctly report their colposcopy pathologic diagnosis

Trial Locations

Locations (1)

Vancouver General Hospital - Gordon and Leslie Diamond Health Care Centre; 🇨🇦 Vancouver, British Columbia, Canada