NCT02027545

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
436

participants targeted

Target at P50-P75 for not_applicable colorectal-cancer

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2013

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 6, 2014

Completed
1.9 years until next milestone

Study Start

First participant enrolled

November 20, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2018

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2018

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

January 10, 2020

Completed
Last Updated

May 3, 2023

Status Verified

April 1, 2023

Enrollment Period

2.7 years

First QC Date

December 18, 2013

Results QC Date

September 18, 2019

Last Update Submit

April 4, 2023

Conditions

Colorectal Cancer

Keywords

cancer screeningdecision making

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Concordance Between Screening Orders and Screening Benefit

    2 weeks

  • Number of Participants With CRC Screening Utilized

    6 months

Study Arms (2)

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.

Behavioral: Decision AidBehavioral: Provider EducationBehavioral: Performance Measure Modification

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.

Behavioral: Provider EducationBehavioral: Performance Measure ModificationBehavioral: Simple Informational Booklet

Interventions

Decision AidBEHAVIORAL

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
Provider EducationBEHAVIORAL

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.

Decision AidNo Decision Aid
Performance Measure ModificationBEHAVIORAL

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.

Decision AidNo Decision Aid
Simple Informational BookletBEHAVIORAL

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

No Decision Aid

Eligibility Criteria

Age70 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Aged 70-75 years
  • Due for screening according to the 2008 USPSTF colorectal cancer screening guideline
  • Scheduled for a non-urgent primary care visit at the Ann Arbor VA Medical Center or Toledo VA Community-Based Outpatient Clinic

You may not qualify if:

  • Increased risk for colorectal cancer (and therefore not candidates for average-risk screening)
  • Limited life expectancy (e.g., enrolled in hospice or diagnosed with metastatic cancer), or for whom the provider previously documented an intention not to pursue screening.
  • Scheduled for an appointment where stimulating a discussion about screening is likely to be inappropriate: urgent appointment (for acute complaints), follow-up visit after hospitalization
  • Have a condition that would impair his/her ability to participate in the study: dementia or other cognitive impairment, visual impairment, non-English speaking
  • Assigned to an ineligible primary care provider (i.e., the provider did not consent to the study)
  • Have Medical Guardian who makes decisions for the patient about his/her care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105, United States

Location

Related Publications (5)

  • 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.

    PMID: 25461993RESULT

  • 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.

    PMID: 26253304RESULT

  • 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.

    PMID: 26456874RESULT

  • 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.

    PMID: 29473344RESULT

  • 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.

    PMID: 37902744DERIVED

Related Links

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Limitations and Caveats

Veteran population, low numbers of women and underrepresented minorities

Results Point of Contact

Title
Sameer D. Saini, MD, MS
Organization
VA Ann Arbor Healthcare System
sameer.saini@va.gov; sdsaini@med.umich.edu
734-845-5865

Study Officials

  • Sameer D. Saini, MD MS

    VA Ann Arbor Healthcare System, Ann Arbor, MI

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: A cluster-randomized (by provider) pragmatic trial of the patient-centered intervention versus pragmatic control.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2013

First Posted

January 6, 2014

Study Start

November 20, 2015

Primary Completion

August 8, 2018

Study Completion

August 22, 2018

Last Updated

May 3, 2023

Results First Posted

January 10, 2020

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)