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Clinical Trial Summary

To assess the efficacy of a novel prompting intervention based on the concept of "implementation intentions.


Clinical Trial Description

Although colorectal cancer (CRC) is preventable and curable if detected early, a large portion of the population is not current with screening recommendations. Many unscreened individuals 50 years of age and older do not receive health care system prompts to promote adherence to test preparation or completion. This study will assess the efficacy of a novel prompting intervention based on the concept of "implementation intentions". The intervention will be delivered through a partnership between patients, rural primary care physicians, and trained CRC information specialists (CRC-IS) and will focus on the 'recalcitrant' primary care population. A randomized design will test a comparison condition of a "no-partnership" system with generic information versus a "partnership" intervention system that specifically addresses each participants' CRC screening "implementation intentions" (the "when," "where" and "how" screening details). The study will be conducted with 600 patients eligible for CRC screening and recruited while presenting for care in a set of Research Network affiliated primary care clinics, or patient contact information gathered from in-house chart reviews. All participants who are not up-to-date on CRC screening, or not at high risk for CRC, will receive a baseline tablet PC-administered CRC assessment, or a letter of invitation from their PC physician to go online to the Healthy Living Kansas patient portal to complete the assessment. Completion of CRC screening at 60 days post index visit will be assessed through follow-up phone calls. Those not completing CRC screening after taking the assessment,(i.e., recalcitrant participants) then will be randomized to either C (comparison group-"no-partnership") or CPI2 (active intervention-CRC-IS/ physician/patient partnership and implementation intentions-based communication concepts). Physicians will receive informational fax sheets summarizing all participant phone calls. A 120-day post randomization follow-up telephone call will assess the effects of implementation intentions communications and perceived CRC screening barriers encountered. The primary outcome will be CRC screening adherence at 120 days. Secondary outcomes will assess 120-day perceived barriers and advancement in screening decisional stage. This intervention will provide information on the utility of embedding an "implementation intentions" based behavioral intervention for promoting CRC screening among initially non-adherent primary care patients. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT00599378
Study type Interventional
Source University of Kansas Medical Center
Contact
Status Completed
Phase N/A
Start date September 2007
Completion date June 2012

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