Evaluating a Preference-based Intervention for Increasing Colorectal Cancer Screening (EPIIC)
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|ClinicalTrials.gov Identifier: NCT00810771|
Recruitment Status : Completed
First Posted : December 18, 2008
Results First Posted : June 2, 2015
Last Update Posted : June 2, 2015
|Condition or disease||Intervention/treatment|
|Colorectal Neoplasms||Behavioral: Standard Information Behavioral: Preference-tailored Information|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||466 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Health Services Research|
|Official Title:||Evaluating a Preference-based Intervention for Increasing CRC Screening|
|Study Start Date :||February 2009|
|Primary Completion Date :||May 2012|
|Study Completion Date :||August 2012|
Experimental: Preference-tailored (PT) intervention
Behavioral: Standard Information Behavioral: Preference-tailored Information
Behavioral: Standard Information
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.Behavioral: Preference-tailored Information
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.
Active Comparator: Standard information (SI) intervention
Behavioral: Standard Information
Behavioral: Standard Information
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.
No Intervention: Usual Care
Due 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.
- Colorectal Cancer (CRC) Screening Rate. [ Time Frame: 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.
- Number of Elements of Braddock's Informed Decision Making (IDM) Model Discussed With Provider [ Time Frame: 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).
- Colorectal Cancer Screening (CRCS) Knowledge and Attitudes. [ Time Frame: 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.
- Decisional Satisfaction [ Time Frame: 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.
- Intent to Get Colorectal Cancer Screening. [ Time Frame: 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).
- Self Efficacy. [ Time Frame: 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.
- If Colorectal Cancer Screening Screening (CRCS) Discussed With Provider. [ Time Frame: 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?"
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00810771
|United States, Michigan|
|VA Ann Arbor Healthcare System|
|Ann Arbor, Michigan, United States, 48113-0170|
|United States, Pennsylvania|
|Center for Health Equity Research and Promotion|
|Pittsburgh, Pennsylvania, United States, 15240|
|Principal Investigator:||Sarah T Hawley, PhD MPH BA||Ann Arbor VA Medical Center|