Uterine Cervical Neoplasms
Conditions
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.
Interventions
OTHERLetter 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.
OTHEREmail
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.
OTHERPhone
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.
OTHERMultimodal
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.
Sponsors
Fenway Community Health
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 64 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Who Receive a Pap Test at End of Follow up | 18 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion Receiving Pap Test at 6 Months | 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 | 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). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 206 |
| 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.
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. | 204 |
| 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.
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. | 208 |
| 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.
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. | 202 |
| 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.
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. | 205 |
| Total | 1,025 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Protocol Violation | 14 | 16 | 12 | 18 | 15 |
Baseline characteristics
| Characteristic | Usual Care / Opportunistic Screening | Letter and Informational Sheet | Phone | Multimodal | Total | |
|---|---|---|---|---|---|---|
| Age, Continuous | 30.5 years STANDARD_DEVIATION 10.8 | 30.7 years STANDARD_DEVIATION 11.3 | 29.7 years STANDARD_DEVIATION 10.9 | 29.5 years STANDARD_DEVIATION 10.3 | 29.9 years STANDARD_DEVIATION 10 | 30.1 years STANDARD_DEVIATION 10.7 |
| Insured | 176 participants | 175 participants | 188 participants | 181 participants | 179 participants | 899 participants |
| Mean Number of Medical Appointments | 10.5 appointments STANDARD_DEVIATION 21.3 | 11.8 appointments STANDARD_DEVIATION 30.2 | 7.4 appointments STANDARD_DEVIATION 10.7 | 9.2 appointments STANDARD_DEVIATION 19.6 | 8.8 appointments STANDARD_DEVIATION 16.9 | 9.5 appointments STANDARD_DEVIATION 20.7 |
| Race/Ethnicity, Customized Asian | 28 participants | 16 participants | 18 participants | 21 participants | 22 participants | 105 participants |
| Race/Ethnicity, Customized Black | 17 participants | 16 participants | 20 participants | 11 participants | 14 participants | 78 participants |
| Race/Ethnicity, Customized Hispanic | 12 participants | 14 participants | 16 participants | 15 participants | 18 participants | 75 participants |
| Race/Ethnicity, Customized Multiracial | 5 participants | 6 participants | 5 participants | 4 participants | 5 participants | 25 participants |
| Race/Ethnicity, Customized Other | 16 participants | 11 participants | 11 participants | 11 participants | 14 participants | 63 participants |
| Race/Ethnicity, Customized Unknown | 5 participants | 5 participants | 5 participants | 7 participants | 2 participants | 24 participants |
| Race/Ethnicity, Customized White | 123 participants | 136 participants | 133 participants | 133 participants | 130 participants | 655 participants |
| Sex/Gender, Customized Female | 190 participants | 195 participants | 197 participants | 188 participants | 193 participants | 963 participants |
| Sex/Gender, Customized Trans/FTM | 16 participants | 9 participants | 11 participants | 14 participants | 12 participants | 62 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 206 | 0 / 204 | 0 / 208 | 0 / 202 | 0 / 205 |
| serious Total, serious adverse events | 0 / 206 | 0 / 204 | 0 / 208 | 0 / 202 | 0 / 205 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care / Opportunistic Screening | Proportion of Patients Who Receive a Pap Test at End of Follow up | 44 Participants |
| Letter and Informational Sheet | Proportion of Patients Who Receive a Pap Test at End of Follow up | 50 Participants |
| Proportion of Patients Who Receive a Pap Test at End of Follow up | 53 Participants | |
| Phone | Proportion of Patients Who Receive a Pap Test at End of Follow up | 59 Participants |
| Multimodal | Proportion of Patients Who Receive a Pap Test at End of Follow up | 74 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care / Opportunistic Screening | Proportion Receiving Pap Test at 12 Months | 34 Participants |
| Letter and Informational Sheet | Proportion Receiving Pap Test at 12 Months | 42 Participants |
| Proportion Receiving Pap Test at 12 Months | 45 Participants | |
| Phone | Proportion Receiving Pap Test at 12 Months | 53 Participants |
| Multimodal | Proportion Receiving Pap Test at 12 Months | 70 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care / Opportunistic Screening | Proportion Receiving Pap Test at 6 Months | 15 Participants |
| Letter and Informational Sheet | Proportion Receiving Pap Test at 6 Months | 32 Participants |
| Proportion Receiving Pap Test at 6 Months | 24 Participants | |
| Phone | Proportion Receiving Pap Test at 6 Months | 43 Participants |
| Multimodal | Proportion Receiving Pap Test at 6 Months | 53 Participants |