Conducting Outreach to Improve Cervical Cancer Screening Rates Among Underscreened Patients
1 other identifier
interventional
1,100
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2013
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 7, 2015
CompletedFirst Posted
Study publicly available on registry
April 28, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedResults Posted
Study results publicly available
June 22, 2017
CompletedJune 22, 2017
June 1, 2017
1.9 years
April 7, 2015
February 18, 2017
June 19, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Proportion Receiving Pap Test at 6 Months
6 months
Proportion Receiving Pap Test at 12 Months
12 months
Study Arms (5)
Usual care / opportunistic screening
NO INTERVENTIONThis 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.
Letter and informational sheet
EXPERIMENTALThe 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.
Phone
EXPERIMENTALThe 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.
Multimodal
EXPERIMENTALThe 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.
Interventions
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.
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 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.
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 27447961DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Jennifer Potter
- Organization
- Fenway Health
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer Potter, MD
Fenway Community Health
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 7, 2015
First Posted
April 28, 2015
Study Start
January 1, 2013
Primary Completion
December 1, 2014
Study Completion
January 1, 2017
Last Updated
June 22, 2017
Results First Posted
June 22, 2017
Record last verified: 2017-06