Evaluating a Preference-based Intervention for Increasing Colorectal Cancer Screening
EPIIC
1 other identifier
interventional
466
1 country
2
Brief Summary
The goal of this study is to evaluate whether an educational tool about colorectal cancer (CRC) completed on a computer that helps patients clarify their CRC screening preferences will lead to increased screening rates for CRC compared to standard information delivered via computer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2009
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2008
CompletedFirst Posted
Study publicly available on registry
December 18, 2008
CompletedStudy Start
First participant enrolled
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedResults Posted
Study results publicly available
June 2, 2015
CompletedJune 2, 2015
June 1, 2015
3.2 years
December 16, 2008
March 26, 2015
June 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Colorectal Cancer (CRC) Screening Rate.
The CRC Screening rate reports percentage of participant adherence with any Colorectal Cancer Screening test within 6 months of Decider Guider intervention. Decider Guider is a tool to help patients make an informed choice about colon cancer testing.
Within 6 months of Decider Guider intervention.
Secondary Outcomes (6)
Number of Elements of Braddock's Informed Decision Making (IDM) Model Discussed With Provider
3-5 days after Decider Guider intervention
Colorectal Cancer Screening (CRCS) Knowledge and Attitudes.
3-5 days after Decider Guider intervention.
Decisional Satisfaction
3-5 days after Decider Guider intervention.
Intent to Get Colorectal Cancer Screening.
3-5 days after Decider Guider intervention.
Self Efficacy.
3-5 days after Decider Guider intervention.
- +1 more secondary outcomes
Study Arms (3)
Preference-tailored (PT) intervention
EXPERIMENTALIntervention: Behavioral: Standard Information Behavioral: Preference-tailored Information
Standard information (SI) intervention
ACTIVE COMPARATORBehavioral: Standard Information
Usual Care
NO INTERVENTIONDue to budget and time constraints this group was not powered as a true study arm but was used to assess the impact of our baseline physician information letter and to control for any other interventions of system-wide initiatives that may occur during the study timeframe and impact rated of CRC screening. Data was not collected on every participant in this arm.
Interventions
A computer based educational overview of CRC and CRC test options will be presented to the subject. The subject will be given a handout with a brief description of each of the screening options and will include the test that they have chosen as their preferred test. The subjects will be asked to take this handout to their upcoming clinic appointment and to discuss the screening options with their care provider.
A preference elicitation exercise that will generate a list of the three top attributes for the subject and the CRC screening test most consistent with these attributes. Subjects will be provided with a handout to take to their clinic appointment as the Standard Information group does, but with the addition of a listing of their top attributes and the test most consistent with their top attributes.
Eligibility Criteria
You may qualify if:
- Clinic appointment at Ann Arbor or Pittsburgh VA during recruitment period.
- Age 50-78.
- Not up to date with CRC screening according to VA and USPSTF guidelines.
- At average risk for CRC (no history of CRC, adenomatous colon polyps, inflammatory bowel disease, and no family history of CRC).
- Has current address and telephone number listed in medical record.
You may not qualify if:
- DNR/DNI code status.
- Metastatic cancer.
- Stage D congestive heart failure.
- Severe COPD.
- Coronary artery disease (CAD) and MI within one year or CAD and unstable angina within 6 months.
- Dementia.
- Inability to conduct activities of daily living.
- Life expectancy less than one year.
- Other - anything else that limits CRC screening options.
- Scheduled for a colonoscopy, sigmoidoscopy, DCBE, or CTC.
- prior participation in this study
- unable to contact after 2 introductory letters (at least 6 months apart)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, 48113-0170, United States
Center for Health Equity Research and Promotion
Pittsburgh, Pennsylvania, 15240, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Usual care arm was not true 3rd arm. We identified pts meeting eligibility criteria \& randomized \~ 10th pt to be followed, measuring CRC screening 6 mos later. No intervention or survey. Only 79.6% of those enrolled completed survey.
Results Point of Contact
- Title
- Sarah Hawley, Ph.D.
- Organization
- VA Ann Arbor Healthcare System, Center for Clinical Management Research
Study Officials
- PRINCIPAL INVESTIGATOR
Sarah T Hawley, PhD MPH BA
Ann Arbor VA Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2008
First Posted
December 18, 2008
Study Start
February 1, 2009
Primary Completion
May 1, 2012
Study Completion
August 1, 2012
Last Updated
June 2, 2015
Results First Posted
June 2, 2015
Record last verified: 2015-06