Colorectal Cancer
Conditions
Keywords
Colorectal Cancer Screening, Cancer Screening, Pragmatic Trial
Brief summary
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.
Detailed description
Phase I (Pilot Aims) * Aim 1 Conduct preliminary analyses of EHR data at two pilot clinics. * Aim 2: Use codes and methods developed in Aim 1 to test the feasibility, reach, effectiveness, and cost of an EHR-based CRC screening intervention using a subset of 100 patients at each of two pilot clinics. We will use codes defined in Aim 1 to create a Solutions-based, Epic-integrated system to track CRC screening, mail FIT kits, and track patient test results and receipt of follow-up care. The system will be pilot-tested in two clinics. * Aim 3: Use results from the pilot intervention to prepare for a large-scale, cluster-randomized pragmatic trial across 18 OCHIN clinics (see Phase II). 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) * Primary Aim 1. Assess the effectiveness of a large-scale, two-arm CRC screening program among diverse CLINIC patients, and assess difference in CRC screening outcomes (overall and by age, sex, insurance status, Hispanic ethnicity/race). The intervention will consist of an automated data-driven, EHR-linked program for mailing FIT kits (with linguistically appropriate pictographic instructions and return postage) to patients due for CRC screening. * Primary Aim 2. Assess the costs and long-term cost-effectiveness of the automated program. We have also included two secondary aims: * Secondary Aim 1. Assess adoption, implementation, reach and potential maintenance and spread of the program, using a mixed-method rapid assessment process, field notes, and other ethnographic data. * Secondary Aim 2. Adapt and pilot-test the adaptation of STOP CRC in an alternate EHR platform, Allscripts, and develop an implementation guide to assist sites in adopting the program.
Interventions
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.
Sponsors
Study design
Eligibility
Inclusion criteria
* Patients aged 50-74 with no evidence of a colonoscopy within 9 years or fecal testing within 11 months, and no history of colorectal disease will be eligible to receive a mailed FIT.
Exclusion criteria
* End Stage Renal Disease (ESRD) * Hospice/Nursing Home
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FIT Completion | Completed FIT kits sent back within 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Any CRC Screening | Any CRC screening complete within 12 months | Binary indication of any CRC screening (fecal test, sigmoidoscopy, or colonoscopy) during the evaluation interval. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
There were 62,155 participants enrolled in the entire study, but 41,193 in the primary analysis.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20,059 |
| 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 | 13 |
| Intervention The intervention consisted of mailed FIT kits, a customized electronic health record (EHR) process and training to support its use. | 21,134 |
| Intervention The intervention consisted of mailed FIT kits, a customized electronic health record (EHR) process and training to support its use. | 13 |
| Total | 41,219 |
Baseline characteristics
| Characteristic | Usual Care | Total | Intervention |
|---|---|---|---|
| Age, Customized Participants aged 50-64 | 84 percentage of participants | 81 percentage of participants | 80 percentage of participants |
| Age, Customized Participants aged 65-75 | 16 percentage of participants | 19 percentage of participants | 20 percentage of participants |
| % Ever had FIT screening | 18 percentage of participants | 18 percentage of participants | 18 percentage of participants |
| Federal Poverty Level 100-150 percent | 18 percentage of participants | 19 percentage of participants | 19 percentage of participants |
| Federal Poverty Level <100 percent | 45 percentage of participants | 46 percentage of participants | 47 percentage of participants |
| Federal Poverty Level 151-200 percent | 9 percentage of participants | 9 percentage of participants | 9 percentage of participants |
| Federal Poverty Level ≥201percent | 10 percentage of participants | 10 percentage of participants | 10 percentage of participants |
| Federal Poverty Level Unknown | 21 percentage of participants | 17 percentage of participants | 17 percentage of participants |
| Insurance Status Commercial | 11 percentage of participants | 11 percentage of participants | 10 percentage of participants |
| Insurance Status Medicaid | 35 percentage of participants | 35 percentage of participants | 36 percentage of participants |
| Insurance Status Medicare | 23 percentage of participants | 23 percentage of participants | 24 percentage of participants |
| Insurance Status Uninsured | 27 percentage of participants | 26 percentage of participants | 26 percentage of participants |
| Language English | 86 percentage of participants | 87 percentage of participants | 90 percentage of participants |
| Language Other | 1 percentage of participants | 1 percentage of participants | 0 percentage of participants |
| Language Spanish | 12 percentage of participants | 8 percentage of participants | 4 percentage of participants |
| Physician Visits in past year 1 visit | 34 percentage of participants | 33 percentage of participants | 29 percentage of participants |
| Physician Visits in past year 2-5 visits | 45 percentage of participants | 45 percentage of participants | 46 percentage of participants |
| Physician Visits in past year ≥6 visits | 19 percentage of participants | 19 percentage of participants | 19 percentage of participants |
| Proportion of Females with Mammogram in past 2 years | 41 percentage of participants | 40 percentage of participants | 39 percentage of participants |
| Proportion of Females with Papanicolaou screening in past 3 years | 42 percentage of participants | 42 percentage of participants | 42 percentage of participants |
| Race/Ethnicity, Customized Hispanic | 15 percentage of participants | 11 percentage of participants | 8 percentage of participants |
| Race/Ethnicity, Customized Non-White, other | 5 percentage of participants | 4 percentage of participants | 3 percentage of participants |
| Race/Ethnicity, Customized White | 91 percentage of participants | 92 percentage of participants | 93 percentage of participants |
| Region of Enrollment United States | 13 Clinics | 26 Clinics | 13 Clinics |
| Sex/Gender, Customized Female | 55 percentage of participants | 56 percentage of participants | 56 percentage of participants |
| Sex/Gender, Customized Male | 45 percentage of participants | 44 percentage of participants | 44 percentage of participants |
| % with Diabetes (ever) | 24 percentage of participants | 22 percentage of participants | 22 percentage of participants |
| % with Flu Shot in past year | 28 percentage of participants | 29 percentage of participants | 29 percentage of participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20,059 | 0 / 21,134 |
| other Total, other adverse events | 0 / 20,059 | 0 / 21,134 |
| serious Total, serious adverse events | 0 / 20,059 | 0 / 21,134 |
Outcome results
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.
Time frame: Completed FIT kits sent back within 12 months
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Usual Care | FIT Completion | 10.4 Model based percentage of participants |
| Intervention | FIT Completion | 13.9 Model based percentage of participants |
Any CRC Screening
Binary indication of any CRC screening (fecal test, sigmoidoscopy, or colonoscopy) during the evaluation interval.
Time frame: Any CRC screening complete within 12 months
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Usual Care | Any CRC Screening | 14.5 Percentage completed any CRC screening |
| Intervention | Any CRC Screening | 18.3 Percentage completed any CRC screening |