Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-01032 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| STUDY00020681 | Other Identifier | OHSU Knight Cancer Institute | |
| UH3CA244298 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Oregon Health and Science University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
This study collects information to provide a model for how to rapidly adapt and scale-up multilevel interventions through clinic-health plan partnerships to reduce the burden of colorectal cancer (CRC) on the United states population. This study may improve colorectal cancer screening rates, follow-up colonoscopy, and referral to care in rural Medicaid patients.
PRIMARY OBJECTIVE:
I. Adapt, pilot, then test the implementation and scale-up of targeted direct mail and patient navigation programs.
OUTLINE:
This is an implementation-effectiveness trial of direct mail outreach and patient navigation intervention to improve rates of CRC screening. Eligible patients will be mailed a fecal immunochemical test (FIT). The mailed FIT and patient navigation interventions are a part of standard care and are carried out by the Medicaid health plan or clinic. Outcomes are tracked using reports from direct mail vendors, claims data from participating Medicaid health plans, clinic data from the electronic health record, chart review, and data from a REDCap database. The hypotheses will be tested using a two-arm cluster randomized trial design. Participating clinics will be randomized into two groups: Intervention and Usual Care. Medicaid health plans/ Coordinated care organizations (CCO) and clinic leadership participate in interviews and complete surveys.
The primary effectiveness outcome of this study is CRC screening likelihood in eligible Medicaid patients in intervention and control clinics at 6 months. Data will be collected at 6 time points: baseline, 6-months, 12-months, 18-months, 24-months, and 36-months.
Implementation outcomes and adaptations will be evaluated through interviews with clinic staff, patients, and CCO partners. Clinic staff in various roles related to the program (e.g., outreach workers, patient navigators, quality improvement leads) complete surveys and participate in interviews and observations at baseline, 6-9 months (post-implementation) and at approximately 12 months later, to assess clinic/health system level factors that may influence outcomes. Patients participate in interviews to explore patient experiences with the program. Regional and Organizational partners: CCO leaders, endoscopy providers (e.g., gastrointestinal specialists, general surgeons, primary care clinicians), and community organizations also participate in interviews.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SMARTER CRC Intervention Year 1 | Active Comparator | In year 1, patients receive mailed FITs from CCO, screening reminders from clinics, and patient navigation as appropriate; Health record data collected. |
|
| SMARTER CRC Usual Care | No Intervention | Usual clinical care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal Immunochemical Test | Other | Patients due for CRC screening are mailed a FIT test by the clinic or health plan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Likelihood of Any Colorectal Cancer (CRC) Screening (for Study-eligible Patients) | Adjusted 6-month any CRC screening for enrollees in clinic units. These values are predicted estimates rather than crude number [%] generated using marginal standardization and accounting for clustering and covariates (i.e., sex, age, and Medicaid health plan). Claims and vendor data were used to determine whether or not the patient completed CRC screening (i.e., fecal testing, FIT-DNA, sigmoidoscopy, CT colonography, or colonoscopy). To assess effectiveness of CRC screening completion, we used the generalized form of hierarchical linear model (binomial distribution with logit link) to account for clustering of patients within clinics and the assignment to arm at the clinic level. | Primary outcome at 6 months following CCO eligible patient list pull date, |
| Measure | Description | Time Frame |
|---|---|---|
| Completion of CRC Screening | Completed CRC screening at 12 months. Claims and vendor data were used to determine whether or not the patient completed CRC screening (i.e., fecal testing, FIT-DNA, sigmoidoscopy, CT colonography, or colonoscopy). | Up to 12 months |
| Rate of CRC Screening Among the Intervention-eligible Population |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Melinda Davis, PhD | OHSU Knight Cancer Institute | Principal Investigator |
| Gloria Coronado, PhD | University of Arizona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OHSU Knight Cancer Institute | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40094661 | Derived | Coronado GD, Petrik AF, Leo MC, Coury J, Durr R, Badicke B, Thompson JH, Edelmann AC, Davis MM. Mailed Outreach and Patient Navigation for Colorectal Cancer Screening Among Rural Medicaid Enrollees: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2025 Mar 3;8(3):e250928. doi: 10.1001/jamanetworkopen.2025.0928. | |
| 38191536 | Derived | Coury J, Coronado G, Currier JJ, Kenzie ES, Petrik AF, Badicke B, Myers E, Davis MM. Methods for scaling up an outreach intervention to increase colorectal cancer screening rates in rural areas. Implement Sci Commun. 2024 Jan 8;5(1):6. doi: 10.1186/s43058-023-00540-1. |
Not provided
Not provided
All non-identifiable data is going to be available through the ACCSIS coordinating center as a public common data set across all the ACCSIS studies along with paper-specific de-identified data sets.
Not provided
Available Now
Not provided
Stratified allocation assignments by clinic unit affiliation (hospital-affiliated, health care network-affiliated, clinic, etc.)
Recruited clinics affiliated with three Medicaid health plans that serve rural counties in Oregon. Clinics had at least 30 age-eligible Medicaid or dually enrolled in Medicaid and Medicare; had CRC screening rates of 60% or lower; and operated in a geographic region designated as rural or frontier. Eligible individuals are ages 50-74 and eligible for CRC screening. Recruitment of clinics happened between May 2020-April 2021.
| ID | Title | Description |
|---|---|---|
| FG000 | SMARTER CRC Intervention Year 1 | In year 1, patients receive mailed FITs from CCO, screening reminders from clinics, and patient navigation as appropriate; Health record data collected. Fecal Immunochemical Test: Patients due for CRC screening are mailed a FIT test by the clinic or health plan Interview: Clinic staff participate in interviews to evaluate the implementation of the mailed FIT and patient navigation programs by the clinics and regional organizations Patient Navigation: Clinic staff are trained in Navigation, patients with an abnormal FIT are contacted about colonoscopy by patient navigators |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| 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 | Jun 7, 2023 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Interview | Other | Participate in interviews to evaluate the implementation of the mailed FIT and patient navigation programs by the clinics and regional organizations |
|
| Patient Navigation | Behavioral | Clinic staff are trained in Navigation, patients with an abnormal FIT are contacted about colonoscopy by patient navigators |
|
|
In the intervention clinics only, the list of patients eligible for screening was scrubbed by clinics. This percent is the N completed CRC screening out of the N included in intervention outreach after clinics scrubbed the list of eligible patients. |
| 6 months |
| Time to Screening From Study-eligible Patient List Pull | Days from study-eligible patient list pull to abnormal FIT result. Number of days at individual level. | Up to 12 months |
| Abnormal FIT Results | Number of participants with abnormal FIT Results | 6 months |
| Patient Navigation Trainings (Intervention Group) | Clinic participation (i.e., attendance) in patient navigation training, Year 1 clinical trial | Up to 12 months |
| Patient Navigation Completed (Intervention Group) | Patient navigation implemented = one or more live phone contact with the patient (binary at the individual level). | Up to 12 months |
| Follow-up Colonoscopy Completion | The percentage of patients with abnormal FIT who completed follow-up colonoscopy within 12 months | Up to 12 months |
| Time to Colonoscopy From Abnormal FIT Result | Days from abnormal FIT result to completion of follow-up colonoscopy. Number of days at the individual level. | Up to 12 months |
| Adenomas or Cancers Detected | Whether or not eligible patient had an adenoma or cancer detected. Binary at individual level. | Up to 12 months |
| Key Implementation Barriers | Qualitative key informant interviews with clinic and payer stakeholders to identify implementation barriers. | Up to 36 months |
| 35418107 | Derived | Coronado GD, Leo MC, Ramsey K, Coury J, Petrik AF, Patzel M, Kenzie ES, Thompson JH, Brodt E, Mummadi R, Elder N, Davis MM. Mailed fecal testing and patient navigation versus usual care to improve rates of colorectal cancer screening and follow-up colonoscopy in rural Medicaid enrollees: a cluster-randomized controlled trial. Implement Sci Commun. 2022 Apr 13;3(1):42. doi: 10.1186/s43058-022-00285-3. |
| FG001 | SMARTER CRC Usual Care | Patients receive usual clinical care in the SMARTER CRC clinics for people eligible for CRC screening. Interview: Clinic staff participate in interviews to evaluate the implementation of the mailed FIT and patient navigation programs by the clinics and regional organizations. |
| Patients |
|
| Staff |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Patients of participating clinics included only. Demographics were not collect on staff participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SMARTER CRC Intervention Year 1 | In year 1, patients receive mailed FITs from CCO, screening reminders from clinics, and patient navigation as appropriate; Health record data collected. Fecal Immunochemical Test: Patients due for CRC screening are mailed a FIT test by the clinic or health plan Interview: Clinic staff participate in interviews to evaluate the implementation of the mailed FIT and patient navigation programs by the clinics and regional organizations Patient Navigation: Clinic staff are trained in Navigation, patients with an abnormal FIT are contacted about colonoscopy by patient navigators |
| BG001 | SMARTER CRC Usual Care | Patients receive usual clinical care in the SMARTER CRC clinics for people eligible for CRC screening. Interview: Clinic staff participate in interviews to evaluate the implementation of the mailed FIT and patient navigation programs by the clinics and regional organizations. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Insurance Status | Count of Participants | Participants |
| ||||||||||||||||
| Rurality (RUCA Codes) | Count of Participants | Participants |
|
| 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 | Likelihood of Any Colorectal Cancer (CRC) Screening (for Study-eligible Patients) | Adjusted 6-month any CRC screening for enrollees in clinic units. These values are predicted estimates rather than crude number [%] generated using marginal standardization and accounting for clustering and covariates (i.e., sex, age, and Medicaid health plan). Claims and vendor data were used to determine whether or not the patient completed CRC screening (i.e., fecal testing, FIT-DNA, sigmoidoscopy, CT colonography, or colonoscopy). To assess effectiveness of CRC screening completion, we used the generalized form of hierarchical linear model (binomial distribution with logit link) to account for clustering of patients within clinics and the assignment to arm at the clinic level. | Intention to treat, multi-level within clinics. One clinic closed immediately after randomization and before patients could be determined eligible before the intervention began. | Posted | Mean | 95% Confidence Interval | Percentage of participants | Primary outcome at 6 months following CCO eligible patient list pull date, |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Completion of CRC Screening | Completed CRC screening at 12 months. Claims and vendor data were used to determine whether or not the patient completed CRC screening (i.e., fecal testing, FIT-DNA, sigmoidoscopy, CT colonography, or colonoscopy). | Intent to treat, multi-level within clinics. One clinic closed after randomization and before the intervention began. | Posted | Mean | 95% Confidence Interval | Percentage of participants | Up to 12 months |
| ||||||||||||||||||||||||||||||
| Secondary | Rate of CRC Screening Among the Intervention-eligible Population | In the intervention clinics only, the list of patients eligible for screening was scrubbed by clinics. This percent is the N completed CRC screening out of the N included in intervention outreach after clinics scrubbed the list of eligible patients. | Patients NOT excluded during the clinic scrub, expected for intervention components. | Posted | Count of Participants | Participants | 6 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Time to Screening From Study-eligible Patient List Pull | Days from study-eligible patient list pull to abnormal FIT result. Number of days at individual level. | Intent to treat eligible patients at clinics | Posted | Mean | Standard Deviation | Days | Up to 12 months |
| ||||||||||||||||||||||||||||||
| Secondary | Abnormal FIT Results | Number of participants with abnormal FIT Results | Intent to treat | Posted | Count of Participants | Participants | 6 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Patient Navigation Trainings (Intervention Group) | Clinic participation (i.e., attendance) in patient navigation training, Year 1 clinical trial | A subset of the total population of clinic staff, who were invited to the patient navigation training | Posted | Count of Participants | Participants | Up to 12 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Patient Navigation Completed (Intervention Group) | Patient navigation implemented = one or more live phone contact with the patient (binary at the individual level). | Patients in intervention clinics eligible for navigation to colonoscopy due to FIT test result or medical factors | Posted | Count of Participants | Participants | Up to 12 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Follow-up Colonoscopy Completion | The percentage of patients with abnormal FIT who completed follow-up colonoscopy within 12 months | Intention to treat, patients in clinics | Posted | Number | Percent of participants | Up to 12 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Time to Colonoscopy From Abnormal FIT Result | Days from abnormal FIT result to completion of follow-up colonoscopy. Number of days at the individual level. | Intention to treat, patients in clinics | Posted | Mean | 95% Confidence Interval | Days | Up to 12 months |
| ||||||||||||||||||||||||||||||
| Secondary | Adenomas or Cancers Detected | Whether or not eligible patient had an adenoma or cancer detected. Binary at individual level. | Intention to treat, patients in clinics | Posted | Number | participants | Up to 12 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Key Implementation Barriers | Qualitative key informant interviews with clinic and payer stakeholders to identify implementation barriers. | Clinic or CCO staff, including patient navigators, who were involved in implementation of the intervention | Posted | Count of Participants | Participants | Up to 36 months |
|
|
Adverse Events were collected over the course of 2 years.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SMARTER CRC Intervention Patients | In year 1, patients receive mailed FITs from CCO, screening reminders from clinics, and patient navigation as appropriate; Health record data collected. Fecal Immunochemical Test: Patients due for CRC screening are mailed a FIT test by the clinic or health plan. | 0 | 2,613 | 0 | 2,613 | 0 | 2,613 |
| EG001 | Usual Care Patients | Patients receive usual clinical care in the SMARTER CRC clinics for people eligible for CRC screening. Interview: Clinic staff participate in interviews to evaluate the implementation of the mailed FIT and patient navigation programs by the clinics and regional organizations. | 0 | 3,001 | 0 | 3,001 | 0 | 3,001 |
| EG002 | Intervention Staff Members | Clinic staff participate in interviews to evaluate the implementation of the mailed FIT and patient navigation programs by the clinics and regional organizations. They also receive patient navigation training. | 0 | 42 | 0 | 42 | 0 | 42 |
| EG003 | Usual Care Staff Members | Clinic staff participate in interviews to evaluate outcomes in the usual care group. | 0 | 40 | 0 | 40 | 0 | 40 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Durr, M.P.H. | Oregon Rural Practice Research Network | 503-418-3592 | durrr@ohsu.edu |
| Mar 18, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 1, 2022 | Mar 18, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007407 | Interviews as Topic |
| D062526 | Patient Navigation |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D018802 | Patient-Centered Care |
| D011320 | Primary Health Care |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Dual Eligible |
|
| Micropolitan |
|
| Small Town |
|
| Rural |
|
| Unknown or Missing |
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
| Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Participants |
|
|
|