Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Department of Veterans Affairs |
---|---|
Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00810771 |
The goal of this study is to evaluate whether a 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 vis computer.
Condition | Intervention |
---|---|
Colorectal Neoplasms |
Behavioral: Standard Information Behavioral: Preference-tailored Information |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Single Blind (Subject), Parallel Assignment |
Official Title: | Evaluating a Preference-Based Intervention for Increasing CRC Screening |
Estimated Enrollment: | 712 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | March 2012 |
Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Preference-tailored (PT) intervention
|
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.
|
2: Active Comparator
Standard information (SI) intervention
|
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.
|
3: No Intervention
"Usual Care" - due to budget and time constraints this is group is not powered as a true study arm but will be 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.
|
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 is under development 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 79 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, and given the chance to remove any potential participants from the contact list. Potential participants will be mailed an introductory letter, and 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 in the patient library, 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 12 months. CRC screening information in a sub-sample of 160 (80 per site) Veterans not in either the PT or SI groups will also be collected to measure "usual care" (UC). 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 12 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: Start-up activities.
Ages Eligible for Study: | 50 Years to 79 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Angela R Larkin, AA BA | (734) 845-3612 | angela.larkin@med.va.gov |
Contact: Sarah T Hawley, BA MPH PhD | (734) 936-8816 | sarahawl@umich.edu |
United States, Michigan | |
VA Ann Arbor Healthcare System | Recruiting |
Ann Arbor, Michigan, United States, 48113-0170 | |
Contact: Angela R Larkin, AA BA 734-845-3612 angela.larkin@med.va.gov | |
Contact: Sarah T Hawley, BA MPH PhD (734) 936-8816 sarahawl@umich.edu | |
Sub-Investigator: Steven J. Katz, MD | |
Sub-Investigator: Myra Kim, ScD MA BA | |
Sub-Investigator: Angela Fagerlin, PhD MA | |
Sub-Investigator: Sandeep Vijan, MD MS | |
Principal Investigator: Sarah T Hawley, BA MPH PhD | |
Sub-Investigator: Joel H Rubenstein, MD | |
United States, Pennsylvania | |
Center for Health Equity Research and Promotion | Not yet recruiting |
Pittsburgh, Pennsylvania, United States, 15206 | |
Contact: Bruce S Ling, MD MPH 412-954-5234 bruce.ling@va.gov | |
Sub-Investigator: Bruce S. Ling, MD MPH |
Principal Investigator: | Sarah T Hawley, BA MPH PhD | Ann Arbor VA Medical Center |
Responsible Party: | Department of Veterans Affairs ( Hawley, Sarah - Principal Investigator ) |
Study ID Numbers: | IIR 06-205 |
Study First Received: | December 16, 2008 |
Last Updated: | May 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00810771 History of Changes |
Health Authority: | United States: Federal Government |
Hospitals, Veterans Mass Screening/utilization Patient Preference Prevention & Control Epidemiology |
Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Gastrointestinal Neoplasms |
Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |
Neoplasms Digestive System Diseases Neoplasms by Site Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases |
Gastrointestinal Neoplasms Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |