Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Herbal and Botanical

All Drugs and Chemicals

Cola

Clinics in usual care will go about clinic practices to complete recommended screening for colorectal cancer.

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.

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.

Auto Plus

Gloria Coronado, PhD

Beverly Green, PhD

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)

* 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.

Strategies and Opportunities to Stop Colon Cancer in Priority Populations

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.

Binary indication of any CRC screening (fecal test, sigmoidoscopy, or colonoscopy) during the evaluation interval.

National Institutes of Health (NIH)

National Center for Complementary and Integrative Health (NCCIH)

Kaiser Permanente

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.

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.

Usual Care

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.

Intervention

Usual care clinics continued their standard processes for CRC screening, which typically consisted of providing information and ordering tests during routine clinical encounters

The intervention consisted of mailed FIT kits, a customized electronic health record (EHR) process and training to support its use.

Total

Participants aged 50-64

Participants aged 65-75

Reported range reflects the range of clinic proportions.

Age, Customized

Female

Male

Sex/Gender, Customized

Hispanic

Data represent the proportion of Hispanic study participants across the individual clinics. Reported range reflects the range of clinic proportions.

Race/Ethnicity, Customized

White

Non-White, other

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.

United States

Region of Enrollment

English

Spanish

Other

Data represent the proportion of study participants by preferred language across the individual clinics. Reported range reflects the range of clinic proportions.

Language

Medicaid

Medicare

Uninsured

Commercial

Data represent the proportion of study participants by Insurance status across the individual clinics. Reported range reflects the range of clinic proportions.

Insurance Status

<100 percent

100-150 percent

151-200 percent

≥201percent

Unknown

Data represent the proportion of study participants by federal poverty stratification across the individual clinics. Reported range reflects the range of clinic proportions.

* \<100 represents a household income below the federal poverty level
* 100-150 represents a household income between 100-150% of the federal poverty level, and so on

Federal Poverty Level

1 visit

2-5 visits

≥6 visits

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.

Physician Visits in past year

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.

% Ever had FIT screening

Data represent the portion of study participants with diabetes diagnosis across the individual clinics. Reported range reflects the range of clinic proportions.

% with Diabetes (ever)

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.

% with Flu Shot in past year

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.

Proportion of Females with Mammogram in past 2 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.

Proportion of Females with Papanicolaou screening in past 3 years

The baseline analysis was conducted at the clinic level

* FIT samples were not processed if missing collection dates
* under-capture of colonoscopy
* screening/diagnostic colonoscopy indistinguishable
* mailed an introduction letter and having a FIT order served as proxy for having been mailed a FIT.

Gloria D. Coronado

Usual care clinics continued their standard processes for CRC screening, which typically consisted of providing information and ordering tests during routine clinical encounters.

The intervention consisted of mailed FIT kits, a customized EHR process and training to support its use.

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.

FIT Completion

Any CRC Screening

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.

Spots Global Cancer Trial Database for auto plus

Every month we try and update this database with for auto plus cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for auto plus

Every month we try and update this database with for auto plus cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for auto plus cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.