Colorectal Carcinoma
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Patients due for CRC screening are mailed a FIT test by the clinic or health plan
OTHERInterview
Participate in interviews to evaluate the implementation of the mailed FIT and patient navigation programs by the clinics and regional organizations
BEHAVIORALPatient Navigation
Clinic staff are trained in Navigation, patients with an abnormal FIT are contacted about colonoscopy by patient navigators
Sponsors
National Cancer Institute (NCI)
Oregon Health and Science University
OHSU Knight Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* CCOs/CCO STAFF: Serving a majority of counties that are predominantly rural based on 2010 Rural-Urban Commuting Area (RUCA) codes (codes 4-10) * CCOs/CCO STAFF: Willing to participate in data collection activities (e.g., producing claims data, interviews) * CLINICS: Clinics will be eligible for the cluster randomization if there are 30 or more patients eligible for screening * CLINICS: Are classified as rural according to RUCA (Codes 4-10) or Oregon Office of Rural Health designations * CLINICS: Are served by CCOs agreeing to participate in the project * CLINICS: Willing to implement the intervention into their clinic for the study * CLINIC STAFF/PROVIDERS: Employed as a clinician or ancillary staff member in a participating clinic * CLINIC STAFF/PROVIDERS: Willing to participate in data collection activities (e.g., interviews, observation, surveys) * PATIENTS: Attributed to participating clinic * PATIENTS: Are enrolled in Medicaid or dual eligible * PATIENTS: Eligible for colorectal cancer (CRC) screening * PATIENTS: For the subset of patients that will be invited to participate in key informant interviews, a 5th eligibility criteria is consented to participate * COMMUNITY OR REGIONAL/ORGANIZATIONAL PARTNERS: (Includes endoscopy providers, community-based outreach workers, or leaders from regional or national organizations who participate in the pilot, pragmatic trial, or scale-up study) * COMMUNITY OR REGIONAL/ORGANIZATIONAL PARTNERS: Involved in study activities (training, care delivery) * COMMUNITY OR REGIONAL/ORGANIZATIONAL PARTNERS: Willing to participate in data collection activities (e.g., trainings, interviews, surveys) * Elderly - Yes - we anticipate that a limited number of clinic and CCO staff, or community organization representatives may be elderly; we limit our patient recruitment to those aged 45-75 * Rural - Yes * Inner city - No * Low income - Yes * Disabled - Yes * Chronic care - Yes * End of life - Yes - This is possible, but we predict limited numbers because of the types of individuals we are recruiting: clinic and CCO staff, and patients who are not currently in hospice care * Minorities - Yes
Exclusion criteria
* CLINICS: Clinics are excluded if they have current or ongoing participating in other mailed fecal testing research projects in the Medicaid population * PATIENTS: Are current for screening * PATIENTS: Comorbid conditions that make patients poor candidates for screening based on clinical judgment (e.g., end-stage renal disease, enrollment in hospice) * PATIENTS: Are not an established patient or for other reasons documented by the clinics * All patients that we recruit will be at least 45 years of age or older
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Likelihood of Any Colorectal Cancer (CRC) Screening (for Study-eligible Patients) | Primary outcome at 6 months following CCO eligible patient list pull date, | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of CRC Screening Among the Intervention-eligible Population | 6 months | 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. |
| Time to Screening From Study-eligible Patient List Pull | Up to 12 months | Days from study-eligible patient list pull to abnormal FIT result. Number of days at individual level. |
| Abnormal FIT Results | 6 months | Number of participants with abnormal FIT Results |
| Patient Navigation Trainings (Intervention Group) | Up to 12 months | Clinic participation (i.e., attendance) in patient navigation training, Year 1 clinical trial |
| Completion of CRC Screening | Up to 12 months | 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). |
| Follow-up Colonoscopy Completion | Up to 12 months | The percentage of patients with abnormal FIT who completed follow-up colonoscopy within 12 months |
| Time to Colonoscopy From Abnormal FIT Result | Up to 12 months | Days from abnormal FIT result to completion of follow-up colonoscopy. Number of days at the individual level. |
| Adenomas or Cancers Detected | Up to 12 months | Whether or not eligible patient had an adenoma or cancer detected. Binary at individual level. |
| Key Implementation Barriers | Up to 36 months | Qualitative key informant interviews with clinic and payer stakeholders to identify implementation barriers. |
| Patient Navigation Completed (Intervention Group) | Up to 12 months | Patient navigation implemented = one or more live phone contact with the patient (binary at the individual level). |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Stratified allocation assignments by clinic unit affiliation (hospital-affiliated, health care network-affiliated, clinic, etc.)
Participants by arm
| Arm | Count |
|---|---|
| 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 | 2,613 |
| 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. | 3,001 |
| Total | 5,614 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 202 | 219 |
Baseline characteristics
| Characteristic | SMARTER CRC Intervention Year 1 | Total | SMARTER CRC Usual Care |
|---|---|---|---|
| Age, Continuous | 58.1 Years STANDARD_DEVIATION 5.4 | 58.2 Years STANDARD_DEVIATION 5.5 | 58.3 Years STANDARD_DEVIATION 5.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 135 Participants | 325 Participants | 190 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2357 Participants | 4940 Participants | 2583 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 121 Participants | 349 Participants | 228 Participants |
| Insurance Status Dual Eligible | 456 Participants | 1059 Participants | 603 Participants |
| Insurance Status Medicaid | 2157 Participants | 4555 Participants | 2398 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 97 Participants | 147 Participants | 50 Participants |
| Race (NIH/OMB) Asian | 30 Participants | 51 Participants | 21 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 35 Participants | 19 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 721 Participants | 1600 Participants | 879 Participants |
| Race (NIH/OMB) White | 1745 Participants | 3774 Participants | 2029 Participants |
| Region of Enrollment United States | 2613 participants | 5614 participants | 3001 participants |
| Rurality (RUCA Codes) Metropolitan | 70 Participants | 800 Participants | 730 Participants |
| Rurality (RUCA Codes) Micropolitan | 1722 Participants | 3402 Participants | 1680 Participants |
| Rurality (RUCA Codes) Rural | 384 Participants | 816 Participants | 432 Participants |
| Rurality (RUCA Codes) Small Town | 431 Participants | 587 Participants | 156 Participants |
| Rurality (RUCA Codes) Unknown or Missing | 6 Participants | 9 Participants | 3 Participants |
| Sex: Female, Male Female | 1334 Participants | 2948 Participants | 1614 Participants |
| Sex: Female, Male Male | 1279 Participants | 2666 Participants | 1387 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2,613 | 0 / 3,001 | 0 / 42 | 0 / 40 |
| other Total, other adverse events | 0 / 2,613 | 0 / 3,001 | 0 / 42 | 0 / 40 |
| serious Total, serious adverse events | 0 / 2,613 | 0 / 3,001 | 0 / 42 | 0 / 40 |
Outcome results
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.
Time frame: Primary outcome at 6 months following CCO eligible patient list pull date,
Population: Intention to treat, multi-level within clinics. One clinic closed immediately after randomization and before patients could be determined eligible before the intervention began.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| SMARTER CRC Intervention Year 1 | Likelihood of Any Colorectal Cancer (CRC) Screening (for Study-eligible Patients) | 11.8 Percentage of participants |
| SMARTER CRC Usual Care | Likelihood of Any Colorectal Cancer (CRC) Screening (for Study-eligible Patients) | 4.5 Percentage of participants |
Secondary
Abnormal FIT Results
Number of participants with abnormal FIT Results
Time frame: 6 months
Population: Intent to treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SMARTER CRC Intervention Year 1 | Abnormal FIT Results | 19 Participants |
| SMARTER CRC Usual Care | Abnormal FIT Results | 7 Participants |
Secondary
Adenomas or Cancers Detected
Whether or not eligible patient had an adenoma or cancer detected. Binary at individual level.
Time frame: Up to 12 months
Population: Intention to treat, patients in clinics
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SMARTER CRC Intervention Year 1 | Adenomas or Cancers Detected | Adenomas | 7 participants |
| SMARTER CRC Intervention Year 1 | Adenomas or Cancers Detected | Cancers | 1 participants |
| SMARTER CRC Usual Care | Adenomas or Cancers Detected | Adenomas | 14 participants |
| SMARTER CRC Usual Care | Adenomas or Cancers Detected | Cancers | 4 participants |
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).
Time frame: Up to 12 months
Population: Intent to treat, multi-level within clinics. One clinic closed after randomization and before the intervention began.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| SMARTER CRC Intervention Year 1 | Completion of CRC Screening | 16.8 Percentage of participants |
| SMARTER CRC Usual Care | Completion of CRC Screening | 9 Percentage of participants |
Secondary
Follow-up Colonoscopy Completion
The percentage of patients with abnormal FIT who completed follow-up colonoscopy within 12 months
Time frame: Up to 12 months
Population: Intention to treat, patients in clinics
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SMARTER CRC Intervention Year 1 | Follow-up Colonoscopy Completion | 49.1 Percent of participants |
| SMARTER CRC Usual Care | Follow-up Colonoscopy Completion | 19.7 Percent of participants |
Secondary
Key Implementation Barriers
Qualitative key informant interviews with clinic and payer stakeholders to identify implementation barriers.
Time frame: Up to 36 months
Population: Clinic or CCO staff, including patient navigators, who were involved in implementation of the intervention
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SMARTER CRC Intervention Year 1 | Key Implementation Barriers | COVID disruptions | 4 Participants |
| SMARTER CRC Intervention Year 1 | Key Implementation Barriers | Staffing Disruptions | 19 Participants |
| SMARTER CRC Intervention Year 1 | Key Implementation Barriers | Mailing Delays | 5 Participants |
| SMARTER CRC Intervention Year 1 | Key Implementation Barriers | Did Not Mention | 54 Participants |
Secondary
Patient Navigation Completed (Intervention Group)
Patient navigation implemented = one or more live phone contact with the patient (binary at the individual level).
Time frame: Up to 12 months
Population: Patients in intervention clinics eligible for navigation to colonoscopy due to FIT test result or medical factors
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SMARTER CRC Intervention Year 1 | Patient Navigation Completed (Intervention Group) | 22 Participants |
Secondary
Patient Navigation Trainings (Intervention Group)
Clinic participation (i.e., attendance) in patient navigation training, Year 1 clinical trial
Time frame: Up to 12 months
Population: A subset of the total population of clinic staff, who were invited to the patient navigation training
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SMARTER CRC Intervention Year 1 | Patient Navigation Trainings (Intervention Group) | 22 Participants |
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.
Time frame: 6 months
Population: Patients NOT excluded during the clinic scrub, expected for intervention components.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SMARTER CRC Intervention Year 1 | Rate of CRC Screening Among the Intervention-eligible Population | 181 Participants |
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.
Time frame: Up to 12 months
Population: Intention to treat, patients in clinics
| Arm | Measure | Value (MEAN) |
|---|---|---|
| SMARTER CRC Intervention Year 1 | Time to Colonoscopy From Abnormal FIT Result | 96.3 Days |
| SMARTER CRC Usual Care | Time to Colonoscopy From Abnormal FIT Result | 114.6 Days |
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.
Time frame: Up to 12 months
Population: Intent to treat eligible patients at clinics
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SMARTER CRC Intervention Year 1 | Time to Screening From Study-eligible Patient List Pull | 118.5 Days | Standard Deviation 293.9 |
| SMARTER CRC Usual Care | Time to Screening From Study-eligible Patient List Pull | 103.2 Days | Standard Deviation 383.2 |