An interventional study of Letter and informational sheet and Email in Uterine Cervical Neoplasms, sponsored by Fenway Community Health. Completed. Open to female participants aged 21 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-22.
Sponsored by Fenway Community Health · Not applicable, Interventional, and Screening
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.
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.
1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.
This study's enrollment of 1,100 is above the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Fenway Community Health is the lead sponsor of 17 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Other: Letter and informational sheet
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 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 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 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.
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).
Time frame: 18 months
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).
Time frame: 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).
Time frame: 12 months
| Milestone | Usual Care / Opportunistic Screening | Letter and Informational Sheet | Phone | Multimodal | |
|---|---|---|---|---|---|
| Started | 220 | 220 | 220 | 220 | 220 |
| Completed | 206 | 204 | 208 | 202 | 205 |
| Not completed | 14 | 16 | 12 | 18 | 15 |
| Withdrew: Protocol violation | 14 | 16 | 12 | 18 | 15 |
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).
| Participants | Usual Care / Opportunistic Screening | Letter and Informational Sheet | Phone | Multimodal | |
|---|---|---|---|---|---|
| Proportion of Patients Who Receive a Pap Test at End of Follow up | 44 | 50 | 53 | 59 | 74 |
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).
| Participants | Usual Care / Opportunistic Screening | Letter and Informational Sheet | Phone | Multimodal | |
|---|---|---|---|---|---|
| Proportion Receiving Pap Test at 6 Months | 15 | 32 | 24 | 43 | 53 |
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).
| Participants | Usual Care / Opportunistic Screening | Letter and Informational Sheet | Phone | Multimodal | |
|---|---|---|---|---|---|
| Proportion Receiving Pap Test at 12 Months | 34 | 42 | 45 | 53 | 70 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Usual Care / Opportunistic Screening | — | 0/206 (0%) | 0/206 (0%) |
| Letter and Informational Sheet | — | 0/204 (0%) | 0/204 (0%) |
| — | 0/208 (0%) | 0/208 (0%) | |
| Phone | — | 0/202 (0%) | 0/202 (0%) |
| Multimodal | — | 0/205 (0%) | 0/205 (0%) |
| Age, Continuous(years) | Usual Care / Opportunistic Screening | Letter and Informational Sheet | Phone | Multimodal | Total | |
|---|---|---|---|---|---|---|
| Mean | 30.5 ± 10.8 | 30.7 ± 11.3 | 29.7 ± 10.9 | 29.5 ± 10.3 | 29.9 ± 10.0 | 30.1 ± 10.7 |
| Sex/Gender, Customized(participants) | Usual Care / Opportunistic Screening | Letter and Informational Sheet | Phone | Multimodal | Total | |
|---|---|---|---|---|---|---|
| Female | 190 | 195 | 197 | 188 | 193 | 963 |
| Trans/FTM | 16 | 9 | 11 | 14 | 12 | 62 |
| Race/Ethnicity, Customized(participants) | Usual Care / Opportunistic Screening | Letter and Informational Sheet | Phone | Multimodal | Total | |
|---|---|---|---|---|---|---|
| White | 123 | 136 | 133 | 133 | 130 | 655 |
| Asian | 28 | 16 | 18 | 21 | 22 | 105 |
| Black | 17 | 16 | 20 | 11 | 14 | 78 |
| Hispanic | 12 | 14 | 16 | 15 | 18 | 75 |
| Multiracial | 5 | 6 | 5 | 4 | 5 | 25 |
| Other | 16 | 11 | 11 | 11 | 14 | 63 |
| Unknown | 5 | 5 | 5 | 7 | 2 | 24 |
| Insured(participants) | Usual Care / Opportunistic Screening | Letter and Informational Sheet | Phone | Multimodal | Total | |
|---|---|---|---|---|---|---|
| Number | 176 | 175 | 188 | 181 | 179 | 899 |
| Mean Number of Medical Appointments(appointments) | Usual Care / Opportunistic Screening | Letter and Informational Sheet | Phone | Multimodal | Total | |
|---|---|---|---|---|---|---|
| Mean | 10.5 ± 21.3 | 11.8 ± 30.2 | 7.4 ± 10.7 | 9.2 ± 19.6 | 8.8 ± 16.9 | 9.5 ± 20.7 |
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