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

NCT03296566 | Completed Results DMC

• 1 other identifier: H16-03194
• Study Type: interventional
• Target: 297
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterine Cervical Dysplasia; Uterine Cervix Cancer

Outcome Measures

Primary Outcomes (3)

• Anxiety

  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.

  To be collected by questionnaire in 4-6 weeks following colposcopy visit

• Quantitative Satisfaction With Colposcopy Visit Experience Including Interactions With Colposcopy Professionals

  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.

  To be collected by questionnaire in 4-6 weeks following colposcopy visit

• Satisfaction With Colposcopy Information and Diagnosis Education

  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.

  To be collected by questionnaire in 4-6 weeks following colposcopy visit

Secondary Outcomes (2)

• Patient Knowledge of Own Colposcopy Diagnosis

  To be collected by questionnaire in 4-6 weeks following colposcopy visit

• Adherence to Colposcopy Treatment and Follow-up Instructions

  6 months

Study Arms (2)

Patient Liaison Intervention

EXPERIMENTAL

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.

Behavioral: Patient Liaison

Control

NO INTERVENTION

The control group will receive the standard of care for colposcopy results reporting via their referring physician. Following their colposcopy visit, control patients are given a slip of paper reminding them to call their family/referring physician for their colposcopy results in three weeks if they have not yet been contacted. Upon receipt of the final pathology, colposcopy reports are prepared by the colposcopists and forwarded to family/referring physicians typically within 2-3 weeks of the visit. Patients then receive the results of their colposcopy report from their family/referring physician by whatever method of communication preferred by that provider.

Interventions

Patient Liaison BEHAVIORAL

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.

Patient Liaison Intervention

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be 19 years of age or older
• Must be patients presenting for an initial visit at the VGH Colposcopy Clinic

You may not qualify if:

• Inability to speak conversational English- required to complete the questionnaire as well as provide informed consent to participate
• Inability or refusal to provide consent
• Pregnant - pregnant women do not usually have biopsies and their subsequent care may be much different than non-pregnant patients
• 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.

Sponsors & Collaborators

• University of British Columbia: lead
• British Columbia Cancer Agency: collaborator
• Women's Health Research Institute of British Columbia: collaborator

Study Sites (1)

Vancouver General Hospital - Gordon and Leslie Diamond Health Care Centre

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Related Publications (11)

• Balasubramani L, Orbell S, Hagger M, Brown V, Tidy J. Can default rates in colposcopy really be reduced? BJOG. 2008 Feb;115(3):403-8. doi: 10.1111/j.1471-0528.2007.01594.x.

  PMID: 18190379 BACKGROUND

• Boone JD, Erickson BK, Huh WK. New insights into cervical cancer screening. J Gynecol Oncol. 2012 Oct;23(4):282-7. doi: 10.3802/jgo.2012.23.4.282. Epub 2012 Sep 19.

  PMID: 23094132 BACKGROUND

• Bredart A, Kop JL, Efficace F, Beaudeau A, Brito T, Dolbeault S, Aaronson N; EORTC Quality of Life Group. Quality of care in the oncology outpatient setting from patients' perspective: a systematic review of questionnaires' content and psychometric performance. Psychooncology. 2015 Apr;24(4):382-94. doi: 10.1002/pon.3661. Epub 2014 Sep 5.

  PMID: 25196048 BACKGROUND

• Byrom J, Clarke T, Neale J, Dunn PD, Hughes GM, Redman CW, Pitts M. Can pre-colposcopy sessions reduce anxiety at the time of colposcopy? A prospective randomised study. J Obstet Gynaecol. 2002 Jul;22(4):415-20. doi: 10.1080/01443610220141407.

  PMID: 12521468 BACKGROUND

• Dietrich AJ, Tobin JN, Cassells A, Robinson CM, Greene MA, Sox CH, Beach ML, DuHamel KN, Younge RG. Telephone care management to improve cancer screening among low-income women: a randomized, controlled trial. Ann Intern Med. 2006 Apr 18;144(8):563-71. doi: 10.7326/0003-4819-144-8-200604180-00006.

  PMID: 16618953 BACKGROUND

• Lerman C, Hanjani P, Caputo C, Miller S, Delmoor E, Nolte S, Engstrom P. Telephone counseling improves adherence to colposcopy among lower-income minority women. J Clin Oncol. 1992 Feb;10(2):330-3. doi: 10.1200/JCO.1992.10.2.330.

  PMID: 1732434 BACKGROUND

• Litchfield IJ, Bentham LM, Lilford RJ, McManus RJ, Greenfield SM. Patient perspectives on test result communication in primary care: a qualitative study. Br J Gen Pract. 2015 Mar;65(632):e133-40. doi: 10.3399/bjgp15X683929.

  PMID: 25733434 BACKGROUND

• Nugent LS, Tamlyn-Leaman K, Isa N, Reardon E, Crumley J. Anxiety and the colposcopy experience. Clin Nurs Res. 1993 Aug;2(3):267-77. doi: 10.1177/105477389300200304.

  PMID: 8401241 BACKGROUND

• O'Connor M, Gallagher P, Waller J, Martin CM, O'Leary JJ, Sharp L; Irish Cervical Screening Research Consortium (CERVIVA). Adverse psychological outcomes following colposcopy and related procedures: a systematic review. BJOG. 2016 Jan;123(1):24-38. doi: 10.1111/1471-0528.13462. Epub 2015 Jun 22.

  PMID: 26099164 BACKGROUND

• Percac-Lima S, Ashburner JM, Zai AH, Chang Y, Oo SA, Guimaraes E, Atlas SJ. Patient Navigation for Comprehensive Cancer Screening in High-Risk Patients Using a Population-Based Health Information Technology System: A Randomized Clinical Trial. JAMA Intern Med. 2016 Jul 1;176(7):930-7. doi: 10.1001/jamainternmed.2016.0841.

  PMID: 27273602 BACKGROUND

• Towler BP, Irwig LM, Shelley JM. The adequacy of management of women with CIN 2 and CIN 3 Pap smear abnormalities. Med J Aust. 1993 Oct 18;159(8):523, 526-8.

  PMID: 8412951 BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Dysplasia; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site

Limitations and Caveats

Small number of subjects analyzed overall, small number of patients completing questionnaire in the control group

Results Point of Contact

• Title: Dr. Marette Lee
• Organization: University of British Columbia

Marette.Lee@vch.ca

604.875.5608

Study Officials

• Marette Lee, MD/MPH/FRCSC

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program Director, BC Provincial Colposcopy Program

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: September 28, 2017
• Study Start: July 13, 2017
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: April 24, 2020
• Results First Posted: April 24, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)