search
Back to results

Conducting Outreach to Improve Cervical Cancer Screening Rates Among Underscreened Patients

Primary Purpose

Uterine Cervical Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Letter and informational sheet
Email
Phone
Multimodal
Sponsored by
Fenway Community Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Uterine Cervical Neoplasms

Eligibility Criteria

21 Years - 64 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    No Intervention

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Usual care / opportunistic screening

    Letter and informational sheet

    Email

    Phone

    Multimodal

    Arm Description

    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.

    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.

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    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).
    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).

    Full Information

    First Posted
    April 7, 2015
    Last Updated
    June 19, 2017
    Sponsor
    Fenway Community Health
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02427399
    Brief Title
    Conducting Outreach to Improve Cervical Cancer Screening Rates Among Underscreened Patients
    Official Title
    Conducting Outreach to Improve Cervical Cancer Screening Rates Among Underscreened Patients at an Urban Community Health Center
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2013 (undefined)
    Primary Completion Date
    December 2014 (Actual)
    Study Completion Date
    January 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fenway Community Health

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Uterine Cervical Neoplasms

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Usual care / opportunistic screening
    Arm Type
    No Intervention
    Arm Description
    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.
    Arm Title
    Letter and informational sheet
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Email
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Phone
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Multimodal
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Letter and informational sheet
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Email
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Phone
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Multimodal
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Proportion of Patients Who Receive a Pap Test at End of Follow up
    Description
    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).
    Time Frame
    18 months
    Secondary Outcome Measure Information:
    Title
    Proportion Receiving Pap Test at 6 Months
    Description
    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).
    Time Frame
    6 months
    Title
    Proportion Receiving Pap Test at 12 Months
    Description
    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).
    Time Frame
    12 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    64 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jennifer Potter, MD
    Organizational Affiliation
    Fenway Community Health
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27447961
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

    Conducting Outreach to Improve Cervical Cancer Screening Rates Among Underscreened Patients

    We'll reach out to this number within 24 hrs