Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Patients of primary care providers randomly assigned to the Decision Aid intervention (DA) that includes an individualized decision aid, provider education, and modified performance measure/reminder.

Patients of primary care providers will be randomly assigned to the pragmatic control (PC) that includes provider education and modified performance measure/reminder, but no decision aid.

Printed booklet comprising educational information about benefits and harms of screening, individualized estimates of benefits and harms of screening, and values clarification exercise

Decision Aid

Providers of patients in both arms of the study will be given an educational module about recent data on the benefits and harms of screening how these data fit in with existing population-centered guidelines.

Provider Education

The clinical reminder system will be modified so to facilitate documentation of informed decision making about CRC screening, including specific reasons for not screening. Additionally, providers who indicate a specific exception for not screening (using the modified clinical reminder) will be considered as satisfying the requirements and will not be penalized in terms of performance pay, and will be removed from feedback reports that encourage population screening.

Performance Measure Modification

A simple informational booklet explaining colorectal cancer screening and current screening recommendations.

Simple Informational Booklet

Sameer D. Saini, MD MS

Systematic efforts to improve colorectal cancer screening use in the VA Healthcare System have resulted in an increase in not only appropriate, but also inappropriate use of screening. The purpose of this study is to test a new, more patient-centered approach to colon cancer screening. In older individuals (ages 70 to 75) who are "due" for screening, the investigators will provide education on the benefits and harms of colon cancer screening. But instead of simply providing these patients with "average" information about these benefits, the investigators will give them information that takes into account their personal characteristics (e.g., age, gender), overall health, and screening history and therefore applies to them more personally. The investigators will also work with the health system to create time and space for patient and doctor to discuss whether screening is the right choice for each individual. This way, patients can make an informed choice about what is right for them, with the help of their doctor. In the future, the results of this study will help patients make more informed screening decisions, especially when the benefits of screening may be uncertain for them personally.

Colorectal cancer (CRC) screening is a widely recommended, evidence-based preventive service that has traditionally been underused. Over the last decade, organized efforts by the Veterans Health Administration (VHA) to increase population screening among Veterans have been successful. But these population-centered efforts have increased screening utilization in a way that is not always concordant with screening benefit, particularly among older Veterans, those with comorbid illness, and those who have previously been screened. As patients get older, acquire health problems, and undergo negative screening tests, the benefit of screening decreases and the potential harm of screening increases. Yet, existing population-centered efforts fail to adequately inform these patients about this changing balance in benefit and harm, often yielding screening utilization that is discordant with benefit. The purpose of this study is to test a more Veteran-centered approach to screening in these individuals, one that encourages informed, personalized screening decisions based on individual values, preferences, and health status.

The 3-part intervention consists of: (1) a decision aid to help Veterans make informed screening decisions; (2) education for providers on how the benefits of screening vary between patients; and (3) modification of clinical reminder systems to allow Veterans to make informed decisions about screening. The intervention will be tested in a pragmatic cluster-randomized controlled trial (cluster = provider) at two sites in the VA Ann Arbor Healthcare System. The primary outcome will be whether screening was ordered at the clinic visit. The investigators will also assess the appropriateness of screening orders (i.e., whether screening is ordered in concordance with screening benefit), conceptual understanding of screening, elements of informed decision-making addressed in the screening discussion, and screening utilization at 6 months.

Note: In March 2023, during preparation of the final manuscript for submission for publication, the study team noted that one subject in the intervention arm had undergone colorectal cancer screening immediately prior to the study visit (but after assessment for study eligibility), making the subject ineligible (protocol violation). Study results were re-analyzed accordingly and updated on clinicaltrials.gov (analyzed N=431 rather than N=432). Additionally, a data entry error was noted on clinicaltrials.gov for the secondary outcome of screening utilization (control N=96 rather than control N=95).

A cluster-randomized (by provider) pragmatic trial of the patient-centered intervention versus pragmatic control.

Promoting Veteran-Centered Colorectal Cancer Screening

The primary dependent variable in the analysis was whether screening was ordered within two weeks after the clinic visit (dichotomous). Screening orders were determined by manual record review of electronic health records.

Defined as the degree to which screening orders align with expected screening benefit, such that individuals with low screening benefit receive screening orders at a lower rate than those with high screening benefit.

We hypothesized that Veterans randomized to the intervention (decision aid) would receive screening orders that were more concordant with screening benefit than those randomized to the control. The expected benefit of screening (reduction in CRC incidence) was calculated using the MISCAN-Colon model. For a given patient, this value was a function of age, gender, health status, and prior screening history. The regression analysis included screening orders as the dependent variable, and, study arm, expected benefit, and an interaction term between study arm and expected benefit as the independent variables. The p-value reported is for the interaction term.

Screening test completion was collected through manual review of electronic medical records.

University of Colorado, Denver

Memorial Sloan Kettering Cancer Center

Erasmus Medical Center

VA Office of Research and Development

There was no contact with subjects for the electronic health record review component of the study, thus, adverse event information was not collected. The survey component examined patient reactions to educational materials and their recent primary care provider visit; adverse event data was not collected.

Patients of primary care providers randomly assigned to the intervention which included 1) a decision aid; 2) modified performance measure/reminder; and, 3) provider education.

1. A printed booklet comprising educational information about benefits and harms of screening, individualized estimates of benefits and harms of screening, and a values clarification exercise.
2. The clinical reminder system was modified to facilitate documentation of informed decision making about CRC screening, including specific reasons for not screening. Providers who indicated an exception for not screening a patient were considered as satisfying the requirements and were not penalized in terms of performance pay. Additionally, the patient was removed from provider feedback reports that encourage population screening.
3. Providers were given information about recent data on the benefits and harms of screening \& how these data fit in with existing population-centered guidelines.

Patients of primary care providers randomly assigned to the pragmatic control which included 1) a simple booklet in place of the decision aid; 2) modified performance measure/reminder; and, 3)provider education.

1. A simple informational booklet explaining colorectal cancer (CRC) screening and current screening recommendations.
2. The clinical reminder system was modified to facilitate documentation of informed decision making about CRC screening, including specific reasons for not screening. Providers who indicated a specific exception for not screening a patient were considered as satisfying the requirements and were not penalized in terms of performance pay. Additionally, the patient was removed from provider feedback reports that encourage population screening.
3. Providers were given information about recent data on the benefits and harms of screening \& how these data fit in with existing population-centered guidelines.

No Decision Aid

Patients of primary care providers randomly assigned to the pragmatic control which included 1) a simple booklet in place of the decision aid; 2) modified performance measure/reminder; and, 3) provider education.

1. A simple informational booklet explaining colorectal cancer (CRC) screening and current screening recommendations.
2. The clinical reminder system was modified to facilitate documentation of informed decision making about CRC screening, including specific reasons for not screening. Providers who indicated a specific exception for not screening a patient were considered as satisfying the requirements and were not penalized in terms of performance pay. Additionally, the patient was removed from provider feedback reports that encourage population screening.
3. Providers were given information about recent data on the benefits and harms of screening \& how these data fit in with existing population-centered guidelines.

Total

Defined as age at date of study visit. Date of birth electronically collected from administrative health record data.

Age, Continuous

Data were collected from electronic administrative health record information.

Sex: Female, Male

White

Black or African American

Native Hawaiian or other Pacific Islander

Native Indian or Alaskan Native

Missing

Race/Ethnicity, Customized

United States

Mailing address was collected via electronic administrative health record data.

Region of Enrollment

Prior Screening

Categorized distribution of screening benefit. Screening benefit is defined as colorectal cancers prevented per 1,000 patients screened.

To create this subject-specific measure, we used a previously published simulation model to estimate the benefit of screening for individual patients according to age, prior screening, sex, and comorbidity.

Screening Benefit

Mean screening benefit is defined as colorectal cancers prevented per 1,000 patients screened.

To create this subject-specific measure, we used a previously published simulation model to estimate the benefit of screening for individual patients according to age, prior screening, sex, and comorbidity.

Mean Benefit from Screening

Current marital status; self-report via survey

Marital Status

Highest level of education obtained; self-report via survey

Education

Veteran population, low numbers of women and underrepresented minorities

Sameer D. Saini, MD, MS

Number of Participants With CRC Screening Ordered

Concordance Between Screening Orders and Screening Benefit

Number of Participants With CRC Screening Utilized

Overall Study

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Participants will be asked to complete the Health Disparities module that is an interactive CME/CE online course which offers 0.5 continuing education credit hours.

The will also be asked to complete the LuCa course.

LuCa is a free interactive CME/CE online course entitled, "Lung Cancer and the Primary Care Provider". For the purpose of this study, participants will be asked to complete session 1 which offers 1.0 continuing education credit hours, including AMA PRA Category 1 credits, AANP, and AAFP Prescribed credits.

The Health Disparity course will review disparities in the burden of lung cancer across racial/ethnic groups, discuss differences in smoking patterns and use of evidence-based smoking cessation, and describe emerging disparities in lung cancer screening. The course will also offer resources for providers to address common barriers to screening among underserved/underrepresented groups, including insurance information, transportation options, procedure time, and patient navigation assistance.

Lesson 1 of the LuCa online course addresses lung cancer screening and shared decision making.

LuCa + Health Disparity module

We are conducting a randomized trial to compare the Health Disparities module to an existing provider module on lung cancer screening to evaluate the impact on primary care providers' knowledge, attitudes, and lung cancer screening referrals of African American and White patients.

We are conducting a randomized trial of two online, provider-facing education modules regarding lung cancer screening and smoking cessation. We will accrue 70 MedStar primary care providers (PCP). The baseline survey will incorporate items regarding lung cancer screening knowledge, providers' attitudes towards lung cancer screening, lung cancer screening ordering practices and provider characteristics. At the end of the baseline survey, PCPs will be randomly assigned to the LuCa + Health Disparities or LuCa only. PCPs will be asked to complete the intervention and the post-test within 1 week of randomization. The post test will cover knowledge of lung cancer screening, attitudes and opinions toward LCS. To assess PCP lung cancer screening ordering practices, we will review the MedConnect Electronic Health Record (EHR) to compare the two study groups post-randomization on the number of orders made for LCS.

Arm 1- LuCa + Health Disparity module: Providers enrolled in the LuCa+ arm will complete lesson 1 of the LuCa training and complete the Health Disparity module. Arm 2- LuCa module: Providers enrolled in the LuCa arm will complete session 1 of the LuCa training.

The research investigators will be blinded from the study arm of the participants.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Promoting Veteran-Centered Colorectal Cancer Screening	NCT02027545	Colorectal Canc...	Decision Aid Provider Educat... Performance Mea... Simple Informat...	70 Years - 75 Years	VA Office of Research and Development
Educating Providers About Lung Screening	NCT05064046	Lung Cancer	LuCa + Health D...	-	Georgetown University

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