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| ID | Type | Description | Link |
|---|---|---|---|
| 01522 | Other Identifier | Corporal Michael J. Crescenz VA Medical Center |
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| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
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The main study aim is to develop, implement and disseminate a pilot population-based mailed FIT outreach screening program in the Philadelphia VA Medical Center that does not rely on having an office visit, by conducting a proof-of-concept 3-arm parallel-design pragmatic randomized trial to (1) Compare the effects of usual care (UC), screening invitation + reminder (invitation-reminder), or screening invitation + mailed FIT kit + reminder (mailed-FIT); (2) Explore whether the FIT completion rate varies by age or race/ethnicity; and (3) Explore barriers to use of mailed outreach screening for Veterans.
This study seeks to establish the foundation to systematically study and improve the delivery and effectiveness of colorectal cancer (CRC) screening in the VA by developing, implementing and disseminating a pilot mailed-FIT screening outreach program that does not rely on having a clinical office visit. The investigators specifically address the need to identify and remediate potential failures to identify and offer screening to eligible Veterans through multilevel interventions. The investigators will also create electronic data linkages to, in future studies, enable evaluation of FIT performance characteristics and help close critical evidence gaps for optimizing screening among Veterans. As this is a pilot study, the focus is to assess feasibility of a population-based screening outreach approach through the development, implementation and dissemination of a mailed FIT outreach program in the Philadelphia VA Medical Center that does not rely on having an office visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | No Intervention | These patients will continue to receive the current practice at the Philadelphia VA Medical Center (VAMC) of offering screening during an office visit. Other interventions will be embedded within this existing program for a pragmatic approach. However, all participants in the trial, including those in usual care (UC), will receive follow-up of test results and navigation to diagnostic colonoscopy for positive FIT results. | |
| Screening invitation-reminder | Active Comparator | Participants will receive UC and also receive an invitation letter with information about CRC testing. The information will include lay-audience description of screening tests and symptoms that should prompt diagnostic work-up. The packet will have instructions to contact the study team if participants believe they are not eligible and to update the contact information on record. The letter will inform participants that a telephone reminder will follow in 4 weeks from invitation letter if screening is not completed. They will also receive notification of test results and navigation to colonoscopy, if needed. For the purposes of this intervention, Week 1 will be the week the invitation letter was sent (time zero). |
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| Mailed-FIT | Active Comparator | Participants randomized to Mailed-FIT will receive a mailed FIT pre-notification letter (plus a screening invitation) followed by the kit 1 week later. Participants will receive instructions to contact the study team if they believe they are not eligible and to update their contact information. They will be informed that a telephone reminder will follow 4 weeks from notification letter if screening is not completed. Participants who do not return their kit within 4 weeks after their pre-notification letter was mailed will receive a live telephone reminder, followed by 2 additional calls at the end of weeks 5 and 6, if needed. For the purposes of this intervention, Week 1 will be the week the pre-notification letter was sent (time zero). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mailed-FIT | Other | The FIT is analyzed at the Philadelphia VAMC by an auto-analyzer system that provides quantitative results corresponding to the concentration of hemoglobin in the collected sample. Specimens will be analyzed according to manufacturer's instructions to minimize potential degradation of hemoglobin. Results are provided as positive if the hemoglobin concentration is 100ng/dL. The machine records (but does not report) the quantitative results of the hemoglobin concentration in the sample, which we will seek to obtain from the laboratory for future studies. |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants Who Completed the Mailed FIT Test Screening Within 6 Months | The completion rate of mailed FIT test within 6 months of the mailing of the screening invitation. The absence of FIT result in the electronic medical record (CRPS) will be considered a failure to complete the FIT test | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants Who Received Any Colorectal Cancer Screening Test in the 6-month Period After Enrollment Into the Study. | The receipt of any colorectal cancer screening test in the 6-month period after enrollment into the study. For patients in the usual care arm, 6 months was counted from the date of mailed letter to arms 2 and 3 within that block of participants. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
Have any known gastrointestinal symptoms such as:
The investigators will also exclude Veterans:
The information used to exclude patients will be derived from the electronic queries or chart audits.
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| Name | Affiliation | Role |
|---|---|---|
| E. Carter Paulson, MD MSCE | Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32564804 | Derived | Goldshore MA, Mehta SJ, Fletcher W, Tzanis G, Doubeni CA, Paulson EC. An RCT of Fecal Immunochemical Test Colorectal Cancer Screening in Veterans Without Recent Primary Care. Am J Prev Med. 2020 Jul;59(1):41-48. doi: 10.1016/j.amepre.2020.02.014. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | These patients will continue to receive the current practice at the Philadelphia VA Medical Center (VAMC) of offering screening during an office visit. Other interventions will be embedded within this existing program for a pragmatic approach. However, all participants in the trial, including those in usual care (UC), will receive follow-up of test results and navigation to diagnostic colonoscopy for positive FIT results. |
| FG001 | Screening Invitation-reminder | Participants will receive UC and also receive an invitation letter with information about CRC testing. The information will include lay-audience description of screening tests and symptoms that should prompt diagnostic work-up. The packet will have instructions to contact the study team if participants believe they are not eligible and to update the contact information on record. The letter will inform participants that a telephone reminder will follow in 4 weeks from invitation letter if screening is not completed. They will also receive notification of test results and navigation to colonoscopy, if needed. For the purposes of this intervention, Week 1 will be the week the invitation letter was sent (time zero). Screening invitation-reminder: These patients will continue to receive UC. They will in addition receive an invitation letter with all of the information about CRC testing in the mail-FIT arm |
| FG002 | Mailed-FIT | Participants randomized to Mailed-FIT will receive a mailed FIT pre-notification letter (+screening invitation) followed by kit 1 week later. Participants will receive instructions to contact the study team if they believe they are not eligible and to update contact information. They will be informed that a telephone reminder will follow 4 weeks from letter if screening not completed. Participants who do not return their kit in 4 weeks will receive a telephone reminder, followed by 2 additional calls at the end of weeks 5 and 6, if needed. For the purposes of this intervention, Week 1 will be the week the pre-notification letter was sent (time zero). Mailed-FIT: The FIT is analyzed at the Philadelphia VAMC by an auto-analyzer system that provides quantitative results corresponding to the concentration of hemoglobin in the collected sample. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | These patients will continue to receive the current practice at the Philadelphia VA Medical Center (VAMC) of offering screening during an office visit. Other interventions will be embedded within this existing program for a pragmatic approach. However, all participants in the trial, including those in usual care (UC), will receive follow-up of test results and navigation to diagnostic colonoscopy for positive FIT results. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Number of Participants Who Completed the Mailed FIT Test Screening Within 6 Months | The completion rate of mailed FIT test within 6 months of the mailing of the screening invitation. The absence of FIT result in the electronic medical record (CRPS) will be considered a failure to complete the FIT test | For this outcome, we just analyzed patients in Arm 3 (n=261), the mailed-FIT kit, arm, as they were the only patients eligible to return a mailed fit kit. | Posted | Count of Participants | Participants | 6 months |
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Adverse events were collected during the same time frame as the primary outcome, which was 6 months from the time of the mailed screening invitation in arms 2 and 3.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | These patients will continue to receive the current practice at the Philadelphia VA Medical Center (VAMC) of offering screening during an office visit. Other interventions will be embedded within this existing program for a pragmatic approach. However, all participants in the trial, including those in usual care (UC), will receive follow-up of test results and navigation to diagnostic colonoscopy for positive FIT results. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emily Carter Paulson, MD MSCA | CMC VAMC | 215-823-5880 | emily.paulson@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 22, 2015 | Jun 7, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| Screening invitation-reminder | Other | These patients will continue to receive UC. They will in addition receive an invitation letter with all of the information about CRC testing in the mail-FIT arm |
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| BG001 | Screening Invitation-reminder | Participants will receive UC and also receive an invitation letter with information about CRC testing. The information will include lay-audience description of screening tests and symptoms that should prompt diagnostic work-up. The packet will have instructions to contact the study team if participants believe they are not eligible and to update the contact information on record. The letter will inform participants that a telephone reminder will follow in 4 weeks from invitation letter if screening is not completed. They will also receive notification of test results and navigation to colonoscopy, if needed. For the purposes of this intervention, Week 1 will be the week the invitation letter was sent (time zero). Screening invitation-reminder: These patients will continue to receive UC. They will in addition receive an invitation letter with all of the information about CRC testing in the mail-FIT arm |
| BG002 | Mailed-FIT | Participants randomized to Mailed-FIT will receive a mailed FIT pre-notification letter (+screening invitation) followed by kit 1 week later. Participants will receive instructions to contact the study team if they believe they are not eligible and to update contact information. They will be informed that a telephone reminder will follow 4 weeks from letter if screening not completed. Participants who do not return their kit in 4 weeks will receive a telephone reminder, followed by 2 additional calls at the end of weeks 5 and 6, if needed. For the purposes of this intervention, Week 1 will be the week the pre-notification letter was sent (time zero). Mailed-FIT: The FIT is analyzed at the Philadelphia VAMC by an auto-analyzer system that provides quantitative results corresponding to the concentration of hemoglobin in the collected sample. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | Screening Invitation-reminder | Participants will receive UC and also receive an invitation letter with information about CRC testing. The information will include lay-audience description of screening tests and symptoms that should prompt diagnostic work-up. The packet will have instructions to contact the study team if participants believe they are not eligible and to update the contact information on record. The letter will inform participants that a telephone reminder will follow in 4 weeks from invitation letter if screening is not completed. They will also receive notification of test results and navigation to colonoscopy, if needed. For the purposes of this intervention, Week 1 will be the week the invitation letter was sent (time zero). Screening invitation-reminder: These patients will continue to receive UC. They will in addition receive an invitation letter with all of the information about CRC testing in the mail-FIT arm |
| OG002 | Mailed-FIT | Participants randomized to Mailed-FIT will receive a mailed FIT pre-notification letter (+screening invitation) followed by kit 1 week later. Participants will receive instructions to contact the study team if they believe they are not eligible and to update contact information. They will be informed that a telephone reminder will follow 4 weeks from letter if screening not completed. Participants who do not return their kit in 4 weeks will receive a telephone reminder, followed by 2 additional calls at the end of weeks 5 and 6, if needed. For the purposes of this intervention, Week 1 will be the week the pre-notification letter was sent (time zero). Mailed-FIT: The FIT is analyzed at the Philadelphia VAMC by an auto-analyzer system that provides quantitative results corresponding to the concentration of hemoglobin in the collected sample. |
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| Secondary | The Number of Participants Who Received Any Colorectal Cancer Screening Test in the 6-month Period After Enrollment Into the Study. | The receipt of any colorectal cancer screening test in the 6-month period after enrollment into the study. For patients in the usual care arm, 6 months was counted from the date of mailed letter to arms 2 and 3 within that block of participants. | We analyzed all randomized patients to identify any CRC screening at 6 months from mailed screening invitation. | Posted | Count of Participants | Participants | 6 months |
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|
|
|
| 1 |
| 260 |
| 0 |
| 260 |
| 0 |
| 260 |
| EG001 | Screening Invitation-reminder | Participants will receive UC and also receive an invitation letter with information about CRC testing. The information will include lay-audience description of screening tests and symptoms that should prompt diagnostic work-up. The packet will have instructions to contact the study team if participants believe they are not eligible and to update the contact information on record. The letter will inform participants that a telephone reminder will follow in 4 weeks from invitation letter if screening is not completed. They will also receive notification of test results and navigation to colonoscopy, if needed. For the purposes of this intervention, Week 1 will be the week the invitation letter was sent (time zero). Screening invitation-reminder: These patients will continue to receive UC. They will in addition receive an invitation letter with all of the information about CRC testing in the mail-FIT arm | 0 | 261 | 0 | 261 | 0 | 261 |
| EG002 | Mailed-FIT | Participants randomized to Mailed-FIT will receive a mailed FIT pre-notification letter (+screening invitation) followed by kit 1 week later. Participants will receive instructions to contact the study team if they believe they are not eligible and to update contact information. They will be informed that a telephone reminder will follow 4 weeks from letter if screening not completed. Participants who do not return their kit in 4 weeks will receive a telephone reminder, followed by 2 additional calls at the end of weeks 5 and 6, if needed. For the purposes of this intervention, Week 1 will be the week the pre-notification letter was sent (time zero). Mailed-FIT: The FIT is analyzed at the Philadelphia VAMC by an auto-analyzer system that provides quantitative results corresponding to the concentration of hemoglobin in the collected sample. | 0 | 261 | 0 | 261 | 0 | 261 |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |