Systems of Support (SOS) to Increase Colon Cancer Screening and Follow-up

Study Overview
=================
Brief Summary
-----------------
SOS is a four-arm randomized controlled study of ways to increase screening for colorectal cancer. About 40-50% of the people age 50 and older are not up to date on screening. This is a very important problem because screening both prevents colorectal cancer and decreases colon cancer deaths. We are studying 3 different levels of support to help people get screened and follow-up after positive screening tests. These involve comparing to usual care stepwise increasing in intensity approaches; an automated approach of mailing information and home screening tests, this plus phone assistance by a medical assistant, both of these plus phone counseling and care management. We will also compare nurse assisted follow-up after a positive screening test compared to usual care By doing this study we hope to increase colon cancer screening rates, and also follow-up rates for positive screening tests.

Detailed Description
-----------------
Systems of Support (SOS) to Increase Colon Cancer Screening and Follow-up A. Specific Aims There is strong evidence that colorectal cancer screening (CRCS) decreases colorectal cancer (CRC) mortality and reduces colorectal cancer incidence. Despite the efficacy of screening, 40-60% of eligible adults are not screened at recommended intervals, and many have never had any type of CRCS. Screening failures occur not only from lack of screening but also from breakdowns in follow-up of positive tests, which obviates the benefits of screening. Strategies for improving the uptake of CRCS typically focus on either patients or health care providers, without describing the infrastructure changes, or systems of support (SOS), that are required to implement and sustain these changes. We propose a two-part study using the Chronic Care Model to organize SOS. We will identify a cohort of Group Health patients aged 50 -73 years who have not had a colonoscopy (CS) in 10 years, a flexible sigmoidoscopy (FS) in 5 years, or a fecal occult blood test (FOBT) in 10 months. Part One: Subjects will be randomized to receive one of four interventions of stepwise increasing intensity of support. Usual care (UC). Automated (UC+ mailed information, access to a cancer screening hotline, mailed FOBT cards, and a reminder card). Assisted (UC + automated + a medical assistant) to document screening intent and assists patients via the resources already supplied or sending requests to the patient's physician. Care management (UC + automated + assisted + cancer screening nurse support) who counsels patient and assists with this screening plan (assessing procedural risk, and ordering tests). Part Two: Patients with a positive FOBT or a positive FS (CS needed) will be randomized to one of two follow-up intervention arms: A. Usual care (which at Group Health includes a registry and physician alerts) or B. Care Management (UC + cancer screening nurse who manages care after a positive test). Our study hypotheses are that increasing levels of SOS will result in increasing CRCS rates, and care management by cancer screening nurses will increase follow-up rates after a positive test. The primary specific aims are: To compare the effectiveness of each intervention condition on increasing CRCS rates. To compare the effectiveness of each intervention condition on follow-up after a positive screening test. The secondary aims are: To assess the effects of each intervention condition on participants' cognitive, affective, and social factors related to CRCS adherence and satisfaction with medical services To compare utilization, costs, and incremental cost-effectiveness of each intervention condition.

Official Title
-----------------
Systems of Support to Increase Colon Cancer Screening and Follow-up

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Behavioral: Automated Mailing
* Behavioral: Automated Mailing Plus Assisted
* Behavioral: Auto Plus Assisted Plus Navigation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Not up to date on CRCS Continuously enrolled in Group Health Cooperative (GHC) for 24 months Expected to continue to be enrolled at GHC for 24 months. Exclusion Criteria: Known high risk for CRC History of CRC History of inflammatory bowel disease Current anticoagulation therapy Organ failure Serious illness Debilitating disease Dementia Nursing home resident.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 73 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1- Usual Care<br>Usual Care (UC) includes an annual birthday letter with information on overdue screening tests including CRC screening. | |
| Experimental: 2 - Automated Mailing<br>Usual care plus automated mailing. Mailing 1 is a pamphlet about screening choices and number to call for colonoscopy. Mailing 2 is a FIT kit if not requesting colonoscopy. Mailing 3 is a Reminder letter. | Behavioral: Automated Mailing<br>* Usual Care plus Automated mailing<br>|
| Experimental: 3 - Automated Mailing Plus Assisted<br>Usual care, automated mailing plus, if screening is still not completed, phone assistance by a medical assistant (MA) who asks about patients screening intent, and provides brief assistance to complete this (e.g. sends another fecal test, assists with provider order for a colonoscopy). | Behavioral: Automated Mailing Plus Assisted<br>* If not screened after automated mailing, MA assists with screening.<br>|
| Experimental: 4 - Auto Plus Assisted Plus Navigation<br>Usual care, automated mailing, phone assistance by a medical assistant, plus navigation by a registered nurse (RN) if still not screened. Navigators are trained to use motivational interviewing techniques. They assess CRC and procedure risk, facilitate screening choice, address barriers, and provide follow-up until screening is completed. | Behavioral: Auto Plus Assisted Plus Navigation<br>* If not screened after automated mailing and assistance by MA, RN begins navigation.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-term adherence to CRC screening | To compare CRC screening adherence by randomization arm: Any screening during years 1 or 2; (b) Screening coverage during both years 1 and 2. | From randomization to the end of 2 years | 
| Long-term adherence to CRC screening | To compare the proportion of time participants are adherent to CRC screening long-term (initial randomization to the end of year 9). | From randomization to the end of 9 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short and long-term adherence to CRC screening for those eligible for re-randomization in year 3 | To compare adherence to CRC screening, among those randomized to receive continued interventions compared to stopped interventions: a) during year 3; b) over the 7 years of follow-up from re-randomization at year 3 through the end of year 9. | From year 3 to the end of 9 years | 
| Impact of SOS interventions on outcomes and CRC-related costs | To compare by randomization arm the impact of SOS interventions on long-term outcomes (advanced adenomas and CRC by stage), costs, and cost-effectiveness. | From randomization to the end of 9 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colorectal Neoplasms, Mass Screening, Population Surveillance, Randomized controlled trial, Occult Blood, Colonoscopy, Sigmoidoscopy, Health Behavior, Colorectal Screening