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| Name | Class |
|---|---|
| University of Colorado, Denver | OTHER |
| Memorial Sloan Kettering Cancer Center | OTHER |
| Erasmus Medical Center | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decision Aid | Experimental | 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. |
|
| No Decision Aid | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decision Aid | Behavioral | Printed booklet comprising educational information about benefits and harms of screening, individualized estimates of benefits and harms of screening, and values clarification exercise |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With CRC Screening Ordered | 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. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Concordance Between Screening Orders and Screening Benefit | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sameer D. Saini, MD MS | VA Ann Arbor Healthcare System, Ann Arbor, MI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Ann Arbor Healthcare System, Ann Arbor, MI | Ann Arbor | Michigan | 48105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25461993 | Result | Saini SD, van Hees F, Vijan S. Smarter screening for cancer: possibilities and challenges of personalization. JAMA. 2014 Dec 3;312(21):2211-2. doi: 10.1001/jama.2014.13933. No abstract available. | |
| 26253304 | Result | van Hees F, Saini SD, Lansdorp-Vogelaar I, Vijan S, Meester RG, de Koning HJ, Zauber AG, van Ballegooijen M. Personalizing colonoscopy screening for elderly individuals based on screening history, cancer risk, and comorbidity status could increase cost effectiveness. Gastroenterology. 2015 Nov;149(6):1425-37. doi: 10.1053/j.gastro.2015.07.042. Epub 2015 Aug 4. |
| Label | URL |
|---|---|
| Click here for more information about this study: Promoting Veteran-Centered Colorectal Cancer Screening | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Decision Aid | 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.
|
| FG001 | 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.
|
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Decision Aid | 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.
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Defined as age at date of study visit. Date of birth electronically collected from administrative health record data. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With CRC Screening Ordered | 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. | Posted | Count of Participants | Participants | 2 weeks |
|
Serious and other (not including serious) adverse events were not collected/assessed as part of this electronic health record review and survey study.
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Decision Aid | 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.
|
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Veteran population, low numbers of women and underrepresented minorities
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sameer D. Saini, MD, MS | VA Ann Arbor Healthcare System | 734-845-5865 | sameer.saini@va.gov; sdsaini@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 30, 2018 | Aug 8, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D003661 | Decision Support Techniques |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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A cluster-randomized (by provider) pragmatic trial of the patient-centered intervention versus pragmatic control.
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| Provider Education | Behavioral | 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. |
|
| Performance Measure Modification | Behavioral | 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. |
|
| Simple Informational Booklet | Behavioral | A simple informational booklet explaining colorectal cancer screening and current screening recommendations. |
|
| 2 weeks |
| Number of Participants With CRC Screening Utilized | Screening test completion was collected through manual review of electronic medical records. | 6 months |
| 26456874 | Result | Caverly TJ, Kerr EA, Saini SD. Delivering Patient-Centered Cancer Screening: Easier Said Than Done. Am J Prev Med. 2016 Jan;50(1):118-121. doi: 10.1016/j.amepre.2015.08.003. Epub 2015 Oct 9. No abstract available. |
| 29473344 | Result | Veenstra CM, Abrahamse P, Wagner TH, Hawley ST, Banerjee M, Morris AM. Employment benefits and job retention: evidence among patients with colorectal cancer. Cancer Med. 2018 Mar;7(3):736-745. doi: 10.1002/cam4.1371. Epub 2018 Feb 23. |
| 37902744 | Derived | Saini SD, Lewis CL, Kerr EA, Zikmund-Fisher BJ, Hawley ST, Forman JH, Zauber AG, Lansdorp-Vogelaar I, van Hees F, Saffar D, Myers A, Gauntlett LE, Lipson R, Kim HM, Vijan S. Personalized Multilevel Intervention for Improving Appropriate Use of Colorectal Cancer Screening in Older Adults: A Cluster Randomized Clinical Trial. JAMA Intern Med. 2023 Dec 1;183(12):1334-1342. doi: 10.1001/jamainternmed.2023.5656. |
| Protocol Violation |
|
| BG001 | 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.
|
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Data were collected from electronic administrative health record information. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Self-reported race via survey. | Count of Participants | Participants |
|
| Region of Enrollment | Mailing address was collected via electronic administrative health record data. | Count of Participants | Participants |
|
| Prior Screening | Data were collected from electronic administrative health record information. | Count of Participants | Participants |
|
| Screening Benefit | 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. | Count of Participants | Participants |
|
| Mean Benefit from Screening | 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 | Standard Deviation | Cancers prevented per 1,000 pts screened |
|
| Marital Status | Current marital status; self-report via survey | Count of Participants | Participants |
|
| Education | Highest level of education obtained; self-report via survey | Count of Participants | Participants |
|
| OG001 | 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.
|
|
|
|
| Secondary | Concordance Between Screening Orders and Screening Benefit | 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. | Posted | Count of Participants | Participants | 2 weeks |
|
|
|
|
| Secondary | Number of Participants With CRC Screening Utilized | Screening test completion was collected through manual review of electronic medical records. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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.
| 0 | 0 | 0 | 0 | 0 | 0 |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |