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Strategies and Opportunities to Stop Colon Cancer in Priority Populations

Strategies and Opportunities to Stop Colon Cancer in Priority Populations

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01742065
Acronym
STOPCRC
Enrollment
62155
Registered
2012-12-05
Start date
2013-01-31
Completion date
2018-08-31
Last updated
2019-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

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

OTHERAuto Plus

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

National Institutes of Health (NIH)
CollaboratorNIH
National Center for Complementary and Integrative Health (NCCIH)
CollaboratorNIH
Kaiser Permanente
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 74 Years
Healthy volunteers
Yes

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

MeasureTime frameDescription
FIT CompletionCompleted FIT kits sent back within 12 monthsBinary 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

MeasureTime frameDescription
Any CRC ScreeningAny CRC screening complete within 12 monthsBinary 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

ArmCount
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
Total41,219

Baseline characteristics

CharacteristicUsual CareTotalIntervention
Age, Customized
Participants aged 50-64
84 percentage of participants81 percentage of participants80 percentage of participants
Age, Customized
Participants aged 65-75
16 percentage of participants19 percentage of participants20 percentage of participants
% Ever had FIT screening18 percentage of participants18 percentage of participants18 percentage of participants
Federal Poverty Level
100-150 percent
18 percentage of participants19 percentage of participants19 percentage of participants
Federal Poverty Level
<100 percent
45 percentage of participants46 percentage of participants47 percentage of participants
Federal Poverty Level
151-200 percent
9 percentage of participants9 percentage of participants9 percentage of participants
Federal Poverty Level
≥201percent
10 percentage of participants10 percentage of participants10 percentage of participants
Federal Poverty Level
Unknown
21 percentage of participants17 percentage of participants17 percentage of participants
Insurance Status
Commercial
11 percentage of participants11 percentage of participants10 percentage of participants
Insurance Status
Medicaid
35 percentage of participants35 percentage of participants36 percentage of participants
Insurance Status
Medicare
23 percentage of participants23 percentage of participants24 percentage of participants
Insurance Status
Uninsured
27 percentage of participants26 percentage of participants26 percentage of participants
Language
English
86 percentage of participants87 percentage of participants90 percentage of participants
Language
Other
1 percentage of participants1 percentage of participants0 percentage of participants
Language
Spanish
12 percentage of participants8 percentage of participants4 percentage of participants
Physician Visits in past year
1 visit
34 percentage of participants33 percentage of participants29 percentage of participants
Physician Visits in past year
2-5 visits
45 percentage of participants45 percentage of participants46 percentage of participants
Physician Visits in past year
≥6 visits
19 percentage of participants19 percentage of participants19 percentage of participants
Proportion of Females with Mammogram in past 2 years41 percentage of participants40 percentage of participants39 percentage of participants
Proportion of Females with Papanicolaou screening in past 3 years42 percentage of participants42 percentage of participants42 percentage of participants
Race/Ethnicity, Customized
Hispanic
15 percentage of participants11 percentage of participants8 percentage of participants
Race/Ethnicity, Customized
Non-White, other
5 percentage of participants4 percentage of participants3 percentage of participants
Race/Ethnicity, Customized
White
91 percentage of participants92 percentage of participants93 percentage of participants
Region of Enrollment
United States
13 Clinics26 Clinics13 Clinics
Sex/Gender, Customized
Female
55 percentage of participants56 percentage of participants56 percentage of participants
Sex/Gender, Customized
Male
45 percentage of participants44 percentage of participants44 percentage of participants
% with Diabetes (ever)24 percentage of participants22 percentage of participants22 percentage of participants
% with Flu Shot in past year28 percentage of participants29 percentage of participants29 percentage of participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 20,0590 / 21,134
other
Total, other adverse events
0 / 20,0590 / 21,134
serious
Total, serious adverse events
0 / 20,0590 / 21,134

Outcome results

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.

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.

ArmMeasureValue (LEAST_SQUARES_MEAN)
Usual CareFIT Completion10.4 Model based percentage of participants
InterventionFIT Completion13.9 Model based percentage of participants
p-value: 0.0595% CI: [0.1, 6.8]Generalized Estimating Equations (GEE)
Secondary

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.

ArmMeasureValue (LEAST_SQUARES_MEAN)
Usual CareAny CRC Screening14.5 Percentage completed any CRC screening
InterventionAny CRC Screening18.3 Percentage completed any CRC screening
p-value: 0.0295% CI: [0.6, 7]Generalized Estimating Equations (GEE)

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026