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| ID | Type | Description | Link |
|---|---|---|---|
| 1UH2AT007782-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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Only an estimated 50 million US adults aged 50-75 are up-to-date on colorectal cancer (CRC) screening according to guidelines set by the federal government. CRC is 90% curable with timely detection and appropriate treatment of precancerous polyps; increased screening could reduce incidence by up to 50%. Groups least likely to undergo screening, those with minimal education, low income, low access to health care, recent immigrants or Hispanics, are the same people who frequently receive care at Federally Qualified Healthcare Center's (FQHCs). The use of fecal occult blood tests (FOBT) and fecal immunochemical tests (FIT) is exceedingly low in FQHCs (7-9% of patients in the past year) and far below national averages and target rates. Our results will provide valuable information on how to use electronic health record (EHR) resources to optimize guideline-based screening in FQHC clinics whose patient populations have disproportionately low CRC screening rates.
This project, in conjunction with the research team, will use an advisory panel to direct the research activities. The advisory panel will be made up of clinicians, leaders, researchers, and patients. The panel and team will guide the development of materials, the outreach to patients, and the research protocol to best reach FQHC patients who are due for colorectal cancer screening.
This project will be conducted in two phases, Phase I is conducting a pilot at two FQHC's, and Phase II is rolling out the intervention to between 20-30 clinics.
Phase I (Pilot Aims)
Transition from Phase I to Phase II
-Changes to our original proposal include going from a three arm to a two-arm pragmatic cluster trial with revised evaluation and power calculation and refinements to the intervention components for both usual care (now described as enhanced usual care) and the intervention (now described as enhanced auto).
Phase II (Full trial Aims)
We have also included two secondary aims:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | Clinics in usual care will go about clinic practices to complete recommended screening for colorectal cancer. | |
| Auto Plus | Active Comparator | Clinics randomized to the Auto-Plus arm will engage in all activities (send an introductory letter to participants, then a FIT Kit, then a reminder letter encouraging the return of the FIT Kit) in addition to a PDSA (Plan Do Study Act) cycle to refine or improve their process. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auto Plus | Other | Clinics randomized to the Auto-Plus arm will engage in all activities in the Auto arm (send an introductory letter to participants, then a FIT Kit, then a reminder letter encouraging the return of the FIT Kit) in addition to one other outreach effort. |
| Measure | Description | Time Frame |
|---|---|---|
| FIT Completion | Binary indication of FIT completion within 12 months or through August 3, 2015 (when usual care clinics received access to study tools). Proportion of completed FIT is represented below with a confidence interval of the difference in completed FIT. | Completed FIT kits sent back within 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Any CRC Screening | Binary indication of any CRC screening (fecal test, sigmoidoscopy, or colonoscopy) during the evaluation interval. | Any CRC screening complete within 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gloria Coronado, PhD | The Center for Health Research, Kaiser Permanente Northwest | Principal Investigator |
| Beverly Green, PhD | Kaiser Permanente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Open Door Health Center | Arcata | California | 95521 | United States | ||
| Mosaic Medical |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24057692 | Background | Coronado GD, Sanchez J, Petrik A, Kapka T, DeVoe J, Green B. Advantages of wordless instructions on how to complete a fecal immunochemical test: lessons from patient advisory council members of a federally qualified health center. J Cancer Educ. 2014 Mar;29(1):86-90. doi: 10.1007/s13187-013-0551-4. | |
| 24937017 | Background | Coronado GD, Vollmer WM, Petrik A, Taplin SH, Burdick TE, Meenan RT, Green BB. Strategies and Opportunities to STOP Colon Cancer in Priority Populations: design of a cluster-randomized pragmatic trial. Contemp Clin Trials. 2014 Jul;38(2):344-9. doi: 10.1016/j.cct.2014.06.006. Epub 2014 Jun 14. |
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There were 62,155 participants enrolled in the entire study, but 41,193 in the primary analysis.
This cluster randomized pragmatic clinical trial was conducted in 26 federally qualified health center clinics, representing 8 health centers in Oregon & California, randomized to intervention (n = 13) or usual care (n = 13). All participants were overdue for colorectal cancer (CRC) screening at some point during accrual interval 2.4.2014-2.3.2015.
| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Usual care clinics continued their standard processes for CRC screening, which typically consisted of providing information and ordering tests during routine clinical encounters. Usual Care clinics were offered training and intervention materials in August 2015. |
| FG001 | Intervention | The intervention consisted of mailed FIT kits, a customized electronic health record (EHR) process and training to support its use. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The baseline analysis was conducted at the clinic level
| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Usual care clinics continued their standard processes for CRC screening, which typically consisted of providing information and ordering tests during routine clinical encounters |
| BG001 | Intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Reported range reflects the range of clinic proportions. |
| 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 | FIT Completion | Binary indication of FIT completion within 12 months or through August 3, 2015 (when usual care clinics received access to study tools). Proportion of completed FIT is represented below with a confidence interval of the difference in completed FIT. | Adult, age 50 to 74 years, clinic visit within 12 months of accrual, and due for CRC screening; no EHR evidence of completed FIT in past 11 months, flexible sigmoidoscopy in past 4 years, colonoscopy in past 9 years, an order for FIT in past 6 months or referral for sigmoidoscopy or colonoscopy in past year. | Posted | Least Squares Mean | 95% Confidence Interval | Model based percentage of participants | Completed FIT kits sent back within 12 months |
|
2.4.2014-8.4.2018, 4.5 years
As our intervention mailed FIT kits to eligible patients (and our primary outcome was completion of FIT), we did not have a systematic way of capturing Severe Adverse Events. Nevertheless, we agreed to document and report to our Data Safety Monitoring Board any Severe Adverse Events we learned about anecdotally from participating clinics, of which there were none.
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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 | Usual care clinics continued their standard processes for CRC screening, which typically consisted of providing information and ordering tests during routine clinical encounters. Usual Care clinics were offered training and intervention materials in August 2015, and therefore patients were followed through the end of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gloria D. Coronado | Kaiser Permanente Center for Health Research | 503 335 2427 | Gloria.D.Coronado@kpchr.org |
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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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| Bend |
| Oregon |
| 97701 |
| United States |
| Benton and Linn County Health Centers | Corvallis | Oregon | 97330 | United States |
| Virginia Garcia Memorial Health Center | Hillsboro | Oregon | 97124 | United States |
| La Clinica Health Care | Medford | Oregon | 97501 | United States |
| Community Health Center | Medford | Oregon | 97504 | United States |
| Multnomah County Health Department | Portland | Oregon | 97214 | United States |
| Oregon Health and Science University | Scappoose | Oregon | 97056 | United States |
| 24571550 | Background | Coronado GD, Vollmer WM, Petrik A, Aguirre J, Kapka T, Devoe J, Puro J, Miers T, Lembach J, Turner A, Sanchez J, Retecki S, Nelson C, Green B. Strategies and opportunities to STOP colon cancer in priority populations: pragmatic pilot study design and outcomes. BMC Cancer. 2014 Feb 26;14:55. doi: 10.1186/1471-2407-14-55. |
| 25729454 | Background | Coronado GD, Schneider JL, Sanchez JJ, Petrik AF, Green B. Reasons for non-response to a direct-mailed FIT kit program: lessons learned from a pragmatic colorectal-cancer screening study in a federally sponsored health center. Transl Behav Med. 2015 Mar;5(1):60-7. doi: 10.1007/s13142-014-0276-x. |
| 25411657 | Background | Coronado GD, Burdick T, Petrik A, Kapka T, Retecki S, Green B. Using an Automated Data-driven, EHR-Embedded Program for Mailing FIT kits: Lessons from the STOP CRC Pilot Study. J Gen Pract (Los Angel). 2014 Jan 5;2:1000141. doi: 10.4172/2329-9126.1000141. |
| 24952378 | Background | Coronado GD, Petrik AF, Spofford M, Talbot J, Do HH, Taylor VM. Clinical perspectives on colorectal cancer screening at Latino-serving federally qualified health centers. Health Educ Behav. 2015 Feb;42(1):26-31. doi: 10.1177/1090198114537061. Epub 2014 Jun 20. |
| 26419905 | Background | Coronado GD, Retecki S, Schneider J, Taplin SH, Burdick T, Green BB. Recruiting community health centers into pragmatic research: Findings from STOP CRC. Clin Trials. 2016 Apr;13(2):214-22. doi: 10.1177/1740774515608122. Epub 2015 Sep 29. |
| 25446054 | Background | Johnson KE, Tachibana C, Coronado GD, Dember LM, Glasgow RE, Huang SS, Martin PJ, Richards J, Rosenthal G, Septimus E, Simon GE, Solberg L, Suls J, Thompson E, Larson EB. A guide to research partnerships for pragmatic clinical trials. BMJ. 2014 Dec 1;349:g6826. doi: 10.1136/bmj.g6826. No abstract available. |
| 30083752 | Background | Coronado GD, Petrik AF, Vollmer WM, Taplin SH, Keast EM, Fields S, Green BB. Effectiveness of a Mailed Colorectal Cancer Screening Outreach Program in Community Health Clinics: The STOP CRC Cluster Randomized Clinical Trial. JAMA Intern Med. 2018 Sep 1;178(9):1174-1181. doi: 10.1001/jamainternmed.2018.3629. |
| 33687606 | Derived | Coronado GD, Nielson CM, Keast EM, Petrik AF, Suls JM. The influence of multi-morbidities on colorectal cancer screening recommendations and completion. Cancer Causes Control. 2021 May;32(5):555-565. doi: 10.1007/s10552-021-01408-2. Epub 2021 Mar 9. |
| 33172444 | Derived | Petrik AF, Keast E, Johnson ES, Smith DH, Coronado GD. Development of a multivariable prediction model to identify patients unlikely to complete a colonoscopy following an abnormal FIT test in community clinics. BMC Health Serv Res. 2020 Nov 10;20(1):1028. doi: 10.1186/s12913-020-05883-2. |
| 33107003 | Derived | Petrik AF, Green B, Schneider J, Miech EJ, Coury J, Retecki S, Coronado GD. Factors Influencing Implementation of a Colorectal Cancer Screening Improvement Program in Community Health Centers: an Applied Use of Configurational Comparative Methods. J Gen Intern Med. 2020 Nov;35(Suppl 2):815-822. doi: 10.1007/s11606-020-06186-2. Epub 2020 Oct 26. |
| 32553027 | Derived | Schneider JL, Rivelli JS, Gruss I, Petrik AF, Nielson CM, Green BB, Coronado GD. Barriers and Facilitators to Timely Colonoscopy Completion for Safety Net Clinic Patients. Am J Health Behav. 2020 Jul 1;44(4):460-472. doi: 10.5993/AJHB.44.4.8. |
| 31941527 | Derived | O'Connor EA, Vollmer WM, Petrik AF, Green BB, Coronado GD. Moderators of the effectiveness of an intervention to increase colorectal cancer screening through mailed fecal immunochemical test kits: results from a pragmatic randomized trial. Trials. 2020 Jan 15;21(1):91. doi: 10.1186/s13063-019-4027-7. |
| 31779517 | Derived | Thompson JH, Schneider JL, Rivelli JS, Petrik AF, Vollmer WM, Fuoco MJ, Coronado GD. A Survey of Provider Attitudes, Beliefs, and Perceived Barriers Regarding a Centralized Direct-Mail Colorectal Cancer Screening Approach at Community Health Centers. J Prim Care Community Health. 2019 Jan-Dec;10:2150132719890950. doi: 10.1177/2150132719890950. |
| 31198661 | Derived | Green BB, Vollmer WM, Keast E, Petrik AF, Coronado GD. Challenges in assessing population reach in a pragmatic trial. Prev Med Rep. 2019 May 29;15:100910. doi: 10.1016/j.pmedr.2019.100910. eCollection 2019 Sep. |
| 30685318 | Derived | Meenan RT, Coronado GD, Petrik A, Green BB. A cost-effectiveness analysis of a colorectal cancer screening program in safety net clinics. Prev Med. 2019 Mar;120:119-125. doi: 10.1016/j.ypmed.2019.01.014. Epub 2019 Jan 24. |
| 30364785 | Derived | Nielson CM, Rivelli JS, Fuoco MJ, Gawlik VR, Jimenez R, Petrik AF, Coronado GD. Effectiveness of automated and live phone reminders after mailed-FIT outreach in a pilot randomized trial. Prev Med Rep. 2018 Oct 17;12:210-213. doi: 10.1016/j.pmedr.2018.10.012. eCollection 2018 Dec. |
| 29019046 | Derived | Coronado GD, Rivelli JS, Fuoco MJ, Vollmer WM, Petrik AF, Keast E, Barker S, Topalanchik E, Jimenez R. Effect of Reminding Patients to Complete Fecal Immunochemical Testing: A Comparative Effectiveness Study of Automated and Live Approaches. J Gen Intern Med. 2018 Jan;33(1):72-78. doi: 10.1007/s11606-017-4184-x. Epub 2017 Oct 10. |
| 28744716 | Derived | Petrik AF, Le T, Keast E, Rivelli J, Bigler K, Green B, Vollmer WM, Coronado G. Predictors of Colorectal Cancer Screening Prior to Implementation of a Large Pragmatic Trial in Federally Qualified Health Centers. J Community Health. 2018 Feb;43(1):128-136. doi: 10.1007/s10900-017-0395-7. |
| 28629348 | Derived | Coury J, Schneider JL, Rivelli JS, Petrik AF, Seibel E, D'Agostini B, Taplin SH, Green BB, Coronado GD. Applying the Plan-Do-Study-Act (PDSA) approach to a large pragmatic study involving safety net clinics. BMC Health Serv Res. 2017 Jun 19;17(1):411. doi: 10.1186/s12913-017-2364-3. |
| 27471224 | Derived | Petrik AF, Green BB, Vollmer WM, Le T, Bachman B, Keast E, Rivelli J, Coronado GD. The validation of electronic health records in accurately identifying patients eligible for colorectal cancer screening in safety net clinics. Fam Pract. 2016 Dec;33(6):639-643. doi: 10.1093/fampra/cmw065. Epub 2016 Jul 28. |
| 26772801 | Derived | Johnson KE, Neta G, Dember LM, Coronado GD, Suls J, Chambers DA, Rundell S, Smith DH, Liu B, Taplin S, Stoney CM, Farrell MM, Glasgow RE. Use of PRECIS ratings in the National Institutes of Health (NIH) Health Care Systems Research Collaboratory. Trials. 2016 Jan 16;17:32. doi: 10.1186/s13063-016-1158-y. |
The intervention consisted of mailed FIT kits, a customized electronic health record (EHR) process and training to support its use.
| BG002 | Total | Total of all reporting groups |
| Clinics |
|
| Median |
| Full Range |
| percentage of participants |
| Clinics |
|
|
| Sex/Gender, Customized | Reported range reflects the range of clinic proportions. | Median | Full Range | percentage of participants | Clinics |
|
|
| Race/Ethnicity, Customized | Data represent the proportion of Hispanic study participants across the individual clinics. Reported range reflects the range of clinic proportions. | Median | Full Range | percentage of participants | Clinics |
|
|
| Race/Ethnicity, Customized | Data represent the proportion of study participants by race (categories: white and non-white, other) across the individual clinics. Reported range reflects the range of clinic proportions. | Median | Full Range | percentage of participants | Clinics |
|
|
| Region of Enrollment | Number | Clinics | Clinics |
|
|
| Language | Data represent the proportion of study participants by preferred language across the individual clinics. Reported range reflects the range of clinic proportions. | Median | Full Range | percentage of participants | Clinics |
|
|
| Insurance Status | Data represent the proportion of study participants by Insurance status across the individual clinics. Reported range reflects the range of clinic proportions. | Median | Full Range | percentage of participants | Clinics |
|
|
| Federal Poverty Level | Data represent the proportion of study participants by federal poverty stratification across the individual clinics. Reported range reflects the range of clinic proportions.
| Median | Full Range | percentage of participants | Clinics |
|
|
| Physician Visits in past year | Data represent the proportion of study participants by number of physician visits in past year across the individual clinics. Reported range reflects the range of clinic proportions. | Median | Full Range | percentage of participants | Clinics |
|
|
| % Ever had FIT screening | Data represent the portion of study participants who have ever had FIT screening across the individual clinics. Reported range reflects the range of clinic proportions. | Median | Full Range | percentage of participants | Clinics |
|
|
| % with Diabetes (ever) | Data represent the portion of study participants with diabetes diagnosis across the individual clinics. Reported range reflects the range of clinic proportions. | Median | Full Range | percentage of participants | Clinics |
|
|
| % with Flu Shot in past year | Data represent the portion of study participants with flu shot in the past year across the individual clinics. Reported range reflects the range of clinic proportions. | Median | Full Range | percentage of participants | Clinics |
|
|
| Proportion of Females with Mammogram in past 2 years | Data represent the proportion of female study participants with a mammogram in the past 2 years across the individual clinics. Reported range reflects the range of clinic proportions. *The percentages are based only on women in the 26 clinics. These data represent the median proportion of women in a clinic with a mammogram. | This baseline measure was only assessed in females. | Median | Full Range | percentage of participants | Clinics |
|
|
| Proportion of Females with Papanicolaou screening in past 3 years | Data represent the proportion of female study participants with papanicolaou screening in past 3 years across the individual clinics. Reported range reflects the range of clinic proportions. *The percentages are based only on women in the 26 clinics. These data represent the median proportion of women in a clinic with papanicolaou screening. | This baseline measure was only assessed in females. | Median | Full Range | percentage of participants | Clinics |
|
|
| OG001 | Intervention | The intervention consisted of mailed FIT kits, a customized EHR process and training to support its use. |
|
|
|
| Secondary | Any CRC Screening | Binary indication of any CRC screening (fecal test, sigmoidoscopy, or colonoscopy) during the evaluation interval. | Adult, age 50 to 74 years, clinic visit within 12 months of accrual, and due for CRC screening; no EHR evidence of completed FIT in past 11 months, flexible sigmoidoscopy in past 4 years, colonoscopy in past 9 years, an order for FIT in past 6 months or referral for sigmoidoscopy or colonoscopy in past year. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage completed any CRC screening | Any CRC screening complete within 12 months |
|
|
|
|
| 0 |
| 20,059 |
| 0 |
| 20,059 |
| 0 |
| 20,059 |
| EG001 | Intervention | The intervention consisted of mailed FIT kits, a customized EHR process and training to support its use. All patients were followed through the end of the study. | 0 | 21,134 | 0 | 21,134 | 0 | 21,134 |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
|
|
|
| Other |
|
|
| Uninsured |
|
| Commercial |
|
|
| 151-200 percent |
|
| ≥201percent |
|
| Unknown |
|
|
| ≥6 visits |
|