Evaluating a Preference-based Intervention for Increasing Colorectal Cancer Screening

Not Applicable

Completed

Conditions: Colorectal Neoplasms

Interventions: Behavioral: Standard Information
Behavioral: Preference-tailored Information

Registration Number: NCT00810771

Lead Sponsor: US Department of Veterans Affairs

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.

Detailed Description: Background: Colorectal cancer (CRC) is a significant and preventable disease, yet CRC screening remains one of the lowest quality indicators in the VA healthcare system. Moreover, a recent VA directive recommends that CRC screening among Veterans should be based on their preferences, given that there is insufficient evidence to support recommending one test. However the impact of such a preference-based strategy on important outcomes, including screening adherence and cost, is unknown.

Objectives: The broad hypothesis of the proposed study is that helping Veterans clarify their CRC screening preferences will lead to increased adherence. The framework conceptualizes that preference clarification leads to more informed decision-making and, eventually, to better adherence with screening. The specific aims are: 1) To test the effectiveness of a preference-tailored (PT) vs. standard information (SI) intervention for increasing Veterans' CRC screening adherence; 2) To assess the impact of the intervention on informed decision making, knowledge and attitudes toward screening, decisional outcomes, and intention to get screened; and 3) To conduct a cost effectiveness analysis of the PT intervention for increasing CRC screening across the VA.

Methods: A randomized controlled trial of the PT vs. SI decision tool will be conducted in the Ann Arbor and Pittsburgh VA healthcare systems. The intervention was developed by the PI working with the Center for Health Communication Research at the University of Michigan. Eligible patients will be 552 (276 per group) Veterans between 50 and 78 who are due for CRC screening, and who have a primary care visit scheduled within the upcoming 4-6 weeks. Those at high risk (e.g., family or personal history of CRC) will be excluded. Providers will be informed of the study via regular mail and email. In Ann Arbor providers will be given the opportunity to opt-out their participants if they choose to do so. In Pittsburgh providers will be given lists of their participants as they are being considered for the study and will be given the chance to remove any potential participants from the contact list. Potential participants will be mailed an introductory letter. Those who do not opt-out will contacted by telephone. Participants will come to their primary care visit 40 minutes early, at which time they will complete informed consent. The intervention will be delivered via the Internet, and participants will be randomized to the PT or SI arm at the time of log-in. Study measures are consistent with the conceptual framework and based on the Preventive Health Model. Preference information will be collected through the computer program. Secondary outcomes and independent variables will be collected via telephone survey 3 days following the intervention. Adherence to screening will be collected from medical charts at 6 months. CRC screening information in a sub-sample of 80 Ann Arbor Veterans, not in either the PT or SI groups, will also be collected to measure "usual care" (UC). Pittsburgh will use the External Peer Review Program (EPRP) for the collection of clinical performance measures, more specifically CRC screening rates, to serve as an effective substitute for the UC group. Hypotheses related to each aim will be tested using multi-level modeling to control for between-provider effects. The overall hypothesis is that patients in the PT group will have higher rates of adherence to CRC screening at the 6 month follow-up point. Cost effectiveness analysis will determine whether a preference-based screening strategy could be cost effective for the VA healthcare system. The PI will work with the investigative team to disseminate the results through local and national VA websites, publications and presentations.

Status: Active, not recruiting.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 466

Inclusion Criteria

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.

Exclusion Criteria

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preference-tailored (PT) intervention	Standard Information	Intervention: Behavioral: Standard Information Behavioral: Preference-tailored Information
Preference-tailored (PT) intervention	Preference-tailored Information	Intervention: Behavioral: Standard Information Behavioral: Preference-tailored Information
Standard information (SI) intervention	Standard Information	Behavioral: Standard Information

Primary Outcome Measures

Name	Time	Method
Colorectal Cancer (CRC) Screening Rate.	Within 6 months of Decider Guider intervention.	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.

Secondary Outcome Measures

Name	Time	Method
Decisional Satisfaction	3-5 days after Decider Guider intervention.	Outcome measures measuring decisional satisfaction using 7-item scale categorized into low, moderate, high. Decisional satisfaction is a measure that was first developed by Margaret Holmes Rover and colleagues (Med Decis Making. 1996 Jan-Mar;16(1):58-64) to assess the perspective of a patient involved in a medical decision with the decision making process. The measure includes questions related to overall satisfaction, and satisfaction with the amount of information received, involvement in, degree of consistency with values, and time to make the decision. The measure includes 5 questions each on a 5 point scale where higher scores = higher satisfaction. When scaled into one overall measure of decision satisfaction, lower scores = lower satisfaction and higher scores = higher satisfaction.
Self Efficacy.	3-5 days after Decider Guider intervention.	Outcome measure measuring self-efficacy using 5-item measure, dichotomized into low vs. high self-efficacy (confidence) in getting screened.
Number of Elements of Braddock's Informed Decision Making (IDM) Model Discussed With Provider	3-5 days after Decider Guider intervention	Outcome measure using 6 items measuring degree of participation in IDM. Scaled and recategorized into Low, Moderate and High level of IDM. The range is from 1 (low level of IDM) to 6 (high level of IDM).
Intent to Get Colorectal Cancer Screening.	3-5 days after Decider Guider intervention.	Outcome measure measuring intent to get CRC screening using 5-item stage of readiness scale. Intent is measured by looking at the highest 2 items (I think I will get screened and I am committed to getting screened).
Colorectal Cancer Screening (CRCS) Knowledge and Attitudes.	3-5 days after Decider Guider intervention.	Outcome measure measuring knowledge of CRCS using 8-item knowledge measure (all true/false questions) developed for study, scaled and categorized into low/moderate/high knowledge, where low = low knowledge and high = high knowledge.
If Colorectal Cancer Screening Screening (CRCS) Discussed With Provider.	3-5 days after Decider Guider intervention.	Outcome measure measuring percentage of participants discussing CRCS with provider using single question (yes/no): "did you discuss Colorectal Cancer Screening with your provider?"

Trial Locations

Locations (2): VA Ann Arbor Healthcare System
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Ann Arbor, Michigan, United States
Center for Health Equity Research and Promotion
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Pittsburgh, Pennsylvania, United States