Conducting Outreach to Improve Cervical Cancer Screening Rates Among Underscreened Patients

Conducting Outreach to Improve Cervical Cancer Screening Rates Among Underscreened Patients at an Urban Community Health Center

The purpose of this project is to determine whether outreach to HIV-negative patients who are overdue for a Pap smear at a New England urban community health center can increase cervical cancer screening rates. It additionally seeks to determine which form of outreach - via letter, email, phone, or a mixture of those modalities- is most effective among these patients.

Study Overview

• Status: Completed
• Conditions: Uterine Cervical Neoplasms
• Intervention / Treatment: Other: Letter and informational sheet; Other: Email; Other: Phone; Other: Multimodal

Detailed Description

To the investigators' knowledge, this study will be the first to assess the efficacy of email in cervical cancer screening outreach in a randomized controlled trial. It will also be one of the few randomized controlled trials to directly compare different outreach media directly, as opposed to different variations within a single medium (e.g. two different types of letters). Lastly, given the unique patient demographic makeup at Fenway, including a significant number of lesbian, bisexual and transgender patients, secondary subanalyses have the potential to significantly add to the investigators' knowledge of what media work best in conducting cervical cancer screening outreach with sexual and gender minorities, who are disproportionately underscreened compared to heterosexual cis-gendered women.

• Study Type: Interventional
• Enrollment (Actual): 1100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female or female-to-male transgender patients with a cervix
• HIV-negative
• Medical appointment at Fenway Community Health during calendar year 2012 who have not had a Pap smear in the past 3 years (since January 2010)

Exclusion Criteria:

• HIV-positive (due to different Pap testing guidelines)
• Male-to-female transgender patients
• Patients with a history of a hysterectomy, unless specified as partial or supracervical
• Patients aged 30-64 who had a negative Pap test in the past 5 years with simultaneous negative Human papillomavirus infection (HPV) co-testing

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care / opportunistic screening; This group will not be contacted by the study team in any way and will receive the general standard of care at Fenway. Patient charts are reviewed by the provider and medical team shortly before a scheduled visit to determine if the patient is due for a Pap, and if so, the patient is offered a Pap during the visit or the chance to schedule one for another date. Any proactive outreach occurs infrequently and at an ad-hoc basis, but should any proactive outreach occur, the study team will not interfere.
Experimental: Letter and informational sheet; The patients in this group will be mailed a letter at time 0. The letter will inform the patient that she is overdue for a Pap and will also contain an informational sheet about cervical cancer and Pap tests. If the patient does not contact Fenway within 1 month to schedule an appointment, an additional letter will be sent at 1 month, and similarly again at 2 months. These letters will be the same, except that letters two and three will mention that previous attempts have been made at contact. Based on best practices in the literature, the letters will be signed by the patient's primary care provider.	Other: Letter and informational sheet; The patients in this group will be mailed a letter at time 0. The letter will inform the patient that she is overdue for a Pap and will also contain an informational sheet about cervical cancer and Pap tests.
Experimental: Email; The same text shared in the letter will be sent as an email to the patients in this intervention group, again at time 0, 1, and 2 months, as necessary for nonresponders. The email will be sent from the provider's email account. The email will have an informational sheet attached or included in the body of the email. The emails will be sent through MyFenway, the secure, Health Insurance Portability and Accountability Act (HIPAA)-compliant patient contact system at Fenway.	Other: Email; The same text shared in the letter will be sent as an email to the patients in this intervention group, again at time 0, 1, and 2 months, as necessary for nonresponders.
Experimental: Phone; The patient will be telephoned and informed that they are due for a Pap, and given the opportunity to schedule an appointment over the phone immediately. As per HIPAA regulations, if the patient does not answer, a voicemail will be left saying that a Fenway representative has called and request that the patient calls back, but a reason will not be given. Some, but not all of the information contained in the info sheet will be provided during the call (see phone script). The script used is consistent with the scripts used currently for patient outreach. A voicemail will still count as one outreach attempt out of three. Patients will be contacted at time 0, 1, and 2 months as necessary for nonresponders.	Other: Phone; The patient will be telephoned and informed that they are due for a Pap, and given the opportunity to schedule an appointment over the phone immediately. Patients will be contacted at time 0, 1, and 2 months as necessary for nonresponders.
Experimental: Multimodal; The patient will be sent a letter/informational sheet at time 0. If she does not respond within one month, she will be sent an email. If she does not respond by 2 months after the start of the intervention period, she will be called. If a patient randomly selected for this group does not have an email listed, she will receive one letter and two phone calls.	Other: Multimodal; The patient will be sent a letter/informational sheet at time 0. If she does not respond within one month, she will be sent an email. If she does not respond by 2 months after the start of the intervention period, she will be called.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Patients Who Receive a Pap Test at End of Follow up	The outcome will be ascertained for each patient through chart review. The effectiveness of each intervention will be assessed through a comparison of screening rates between each of the four intervention arms (letter, email, phone, letter/email/phone) and the control arm (usual care/opportunistic screening).	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion Receiving Pap Test at 6 Months	The outcome will be ascertained for each patient through chart review. The effectiveness of each intervention will be assessed through a comparison of screening rates between each of the four intervention arms (letter, email, phone, letter/email/phone) and the control arm (usual care/opportunistic screening).	6 months
Proportion Receiving Pap Test at 12 Months	The outcome will be ascertained for each patient through chart review. The effectiveness of each intervention will be assessed through a comparison of screening rates between each of the four intervention arms (letter, email, phone, letter/email/phone) and the control arm (usual care/opportunistic screening).	12 months

Collaborators and Investigators

• Sponsor: Fenway Community Health
• Investigators: Principal Investigator: Jennifer Potter, MD, Fenway Community Health

Publications and helpful links

General Publications

• Peitzmeier SM, Khullar K, Potter J. Effectiveness of four outreach modalities to patients overdue for cervical cancer screening in the primary care setting: a randomized trial. Cancer Causes Control. 2016 Sep;27(9):1081-91. doi: 10.1007/s10552-016-0786-6. Epub 2016 Jul 22.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: April 7, 2015
• First Submitted That Met QC Criteria: April 27, 2015
• First Posted (Estimate): April 28, 2015

Study Record Updates

• Last Update Posted (Actual): June 22, 2017
• Last Update Submitted That Met QC Criteria: June 19, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms
• Other Study ID Numbers: Cervical Cancer Screening