Trial Outcomes & Findings for Conducting Outreach to Improve Cervical Cancer Screening Rates Among Underscreened Patients (NCT NCT02427399)

Last Updated: 2017-06-22

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

1100 participants

Primary outcome timeframe

18 months

Results posted on

2017-06-22

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.	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.	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.	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.
Overall Study STARTED	220	220	220	220	220
Overall Study COMPLETED	206	204	208	202	205
Overall Study NOT COMPLETED	14	16	12	18	15

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.	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.	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.
Overall Study Protocol Violation	14	16	12	18	15

Baseline Characteristics

Conducting Outreach to Improve Cervical Cancer Screening Rates Among Underscreened Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care / Opportunistic Screening n=206 Participants 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.	Letter and Informational Sheet n=204 Participants 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.	Email n=208 Participants 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.	Phone n=202 Participants 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.	Multimodal n=205 Participants 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.	Total n=1025 Participants Total of all reporting groups
Age, Continuous	30.5 years STANDARD_DEVIATION 10.8 • n=5 Participants	30.7 years STANDARD_DEVIATION 11.3 • n=7 Participants	29.7 years STANDARD_DEVIATION 10.9 • n=5 Participants	29.5 years STANDARD_DEVIATION 10.3 • n=4 Participants	29.9 years STANDARD_DEVIATION 10.0 • n=21 Participants	30.1 years STANDARD_DEVIATION 10.7 • n=10 Participants
Sex/Gender, Customized Female	190 participants n=5 Participants	195 participants n=7 Participants	197 participants n=5 Participants	188 participants n=4 Participants	193 participants n=21 Participants	963 participants n=10 Participants
Sex/Gender, Customized Trans/FTM	16 participants n=5 Participants	9 participants n=7 Participants	11 participants n=5 Participants	14 participants n=4 Participants	12 participants n=21 Participants	62 participants n=10 Participants
Race/Ethnicity, Customized White	123 participants n=5 Participants	136 participants n=7 Participants	133 participants n=5 Participants	133 participants n=4 Participants	130 participants n=21 Participants	655 participants n=10 Participants
Race/Ethnicity, Customized Asian	28 participants n=5 Participants	16 participants n=7 Participants	18 participants n=5 Participants	21 participants n=4 Participants	22 participants n=21 Participants	105 participants n=10 Participants
Race/Ethnicity, Customized Black	17 participants n=5 Participants	16 participants n=7 Participants	20 participants n=5 Participants	11 participants n=4 Participants	14 participants n=21 Participants	78 participants n=10 Participants
Race/Ethnicity, Customized Hispanic	12 participants n=5 Participants	14 participants n=7 Participants	16 participants n=5 Participants	15 participants n=4 Participants	18 participants n=21 Participants	75 participants n=10 Participants
Race/Ethnicity, Customized Multiracial	5 participants n=5 Participants	6 participants n=7 Participants	5 participants n=5 Participants	4 participants n=4 Participants	5 participants n=21 Participants	25 participants n=10 Participants
Race/Ethnicity, Customized Other	16 participants n=5 Participants	11 participants n=7 Participants	11 participants n=5 Participants	11 participants n=4 Participants	14 participants n=21 Participants	63 participants n=10 Participants
Race/Ethnicity, Customized Unknown	5 participants n=5 Participants	5 participants n=7 Participants	5 participants n=5 Participants	7 participants n=4 Participants	2 participants n=21 Participants	24 participants n=10 Participants
Insured	176 participants n=5 Participants	175 participants n=7 Participants	188 participants n=5 Participants	181 participants n=4 Participants	179 participants n=21 Participants	899 participants n=10 Participants
Mean Number of Medical Appointments	10.5 appointments STANDARD_DEVIATION 21.3 • n=5 Participants	11.8 appointments STANDARD_DEVIATION 30.2 • n=7 Participants	7.4 appointments STANDARD_DEVIATION 10.7 • n=5 Participants	9.2 appointments STANDARD_DEVIATION 19.6 • n=4 Participants	8.8 appointments STANDARD_DEVIATION 16.9 • n=21 Participants	9.5 appointments STANDARD_DEVIATION 20.7 • n=10 Participants

PRIMARY outcome

Timeframe: 18 months

Outcome measures

Outcome measures
Measure	Usual Care / Opportunistic Screening n=206 Participants 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.	Letter and Informational Sheet n=204 Participants 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.	Email n=208 Participants 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.	Phone n=202 Participants 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.	Multimodal n=205 Participants 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.
Proportion of Patients Who Receive a Pap Test at End of Follow up	44 Participants	50 Participants	53 Participants	59 Participants	74 Participants

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Usual Care / Opportunistic Screening n=206 Participants 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.	Letter and Informational Sheet n=204 Participants 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.	Email n=208 Participants 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.	Phone n=202 Participants 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.	Multimodal n=205 Participants 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.
Proportion Receiving Pap Test at 6 Months	15 Participants	32 Participants	24 Participants	43 Participants	53 Participants

SECONDARY outcome

Timeframe: 12 months