- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00593073
Use of Novel Tailored Reminders in Rural Primary Care
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Screening for colorectal cancer (CRC) remains severely underutilized. Although simple reminders are modestly effective in enhancing preventive care utilization, they are not widely utilized. Even if used widely, the effectiveness of simple reminders is limited, leaving nearly half of patients without screening. One explanation for this is that simple reminders do not address the barriers and resources of the patients and physicians they are designed to prompt. In this study, we will examine the impact on CRC screening of a reminder system that uses the physician as the message source and is tailored to the physician screening preferences and patient-reported characteristics, CRC screening-related barriers, status and CRC susceptibility. This intervention will be compared to a standard CRC health education and screening reminder system.
Touch screen 'Healthy Living' computer kiosks will be placed in 16 Kansas Physicians Engaged in Prevention Research (KPEPR) Network primary care practices. The kiosk program will screen for eligible participants who are at least 50 years of age and not up-to-date with CRC screening and guide eligible participants through a computerized Colorectal Cancer Assessment (CRCA). Kiosk participants will be randomized into either a general CRC health education + screening reminder message (GRM) (N=640) or a patient and physician-tailored CRC + screening reminder message (TRM) (N=640). Immediately upon completion of the CRCA, GRM participants will receive a brief informational flyer with general CRC health education messages and a reminder to get screened routinely for CRC. Participants in the TRM arm will receive an informational flyer that contains messages that are tailored to patient CRC screening barriers, preferences, and attitudes and physician screening preferences (guided by CRC screening options that are available within the local community) in addition to a reminder to get screened for CRC. A 90-day telephone follow-up will assess participant compliance with CRC screening recommendations, participant discussion with their physician regarding CRC screening, and patient satisfaction.
This study will use a novel patient- and physician- tailored messaging approach to promote colorectal cancer screening utilization. This study will help to assess how a practice-based computerized patient activation approach can effectively circumvent the "systems problems" endemic in rural primary care and lay the groundwork for future computer-based primary care intervention studies to help patients make informed health decisions and engage in healthy lifestyle behaviors.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kansas
-
Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 50 years of age or older
- at average risk for colorectal cancer
- not up to date with colorectal cancer screening
Exclusion Criteria:
- Younger than 50 years of age
- at high risk for colorectal cancer
- up to date with colorectal cancer screening
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
Tailored Reminder Message
|
Tailored CRC message based on patient screening barriers, preferences and attitudes and reminder to get screened.
|
|
Experimental: 2
General Reminder Message
|
General CRC health education message and reminder to get screened.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Baseline assessment while waiting to see primary care physician and 90-day follow-up telephone survey.
Time Frame: Baseline, 90 Days
|
Baseline, 90 Days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Follow-up survey to assess participant discussion of colorectal cancer with their healthcare provider and compliance with CRC screening
Time Frame: 90 Days
|
90 Days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kimberly K. Engelman, PhD, University of Kansas Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10174
- 1R21CA121907-01 (U.S. NIH Grant/Contract)
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