NCT03296566

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

Completed NA Results posted Last updated 24 April 2020

What this trial tests

NA trial testing Patient Liaison in Uterine Cervical Dysplasia in 297 participants. Completed in 30 June 2018.

Timeline

13 July 2017

Primary endpoint
30 June 2018

30 June 2018

Quick facts

Lead sponsor	University of British Columbia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	health services research
Enrollment	297
Start date	13 July 2017
Primary completion	30 June 2018
Estimated completion	30 June 2018
Sites	1 location across Canada

Drugs / interventions tested

• Patient Liaison

Conditions studied

• Uterine Cervical Dysplasia — all drugs for Uterine Cervical Dysplasia →
• Uterine Cervix Cancer — all drugs for Uterine Cervix Cancer →

Sponsor

University of British Columbia

Who can join

19 and older, female only, with Uterine Cervical Dysplasia or Uterine Cervix Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Anxiety Primary · 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). Rang

Group	Value	95% CI
Patient Liaison Intervention	37.3	± 12.8
Control	40.7	± 11.2

Quantitative Satisfaction With Colposcopy Visit Experience Including Interactions With Colposcopy Professionals Primary · 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 respo

Group	Value	95% CI
Patient Liaison Intervention	68.3	± 19.2
Control	66.6	± 18.2

Satisfaction With Colposcopy Information and Diagnosis Education Primary · 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

Group	Value	95% CI
Patient Liaison Intervention	65.6	± 11.4
Control	65.1	± 11.1

Patient Knowledge of Own Colposcopy Diagnosis Secondary · To be collected by questionnaire in 4-6 weeks following colposcopy visit

The percent of patients who correctly report their colposcopy pathologic diagnosis

Group	Value	95% CI
Patient Liaison Intervention	66.3
Control	84

Adherence to Colposcopy Treatment and Follow-up Instructions Secondary · 6 months

Percentage of patients who attended follow-up at the colposcopy clinic

Group	Value	95% CI
Patient Liaison Intervention	61.4
Control	52.3

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.