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Use of Novel Tailored Reminders in Rural Primary Care

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electronic tailored messaging
General Reminder Message
Sponsored by
University of Kansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Tailored Reminder Message

General Reminder Message

Outcomes

Primary Outcome Measures

Baseline assessment while waiting to see primary care physician and 90-day follow-up telephone survey.

Secondary Outcome Measures

Follow-up survey to assess participant discussion of colorectal cancer with their healthcare provider and compliance with CRC screening

Full Information

First Posted
December 31, 2007
Last Updated
September 10, 2008
Sponsor
University of Kansas
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00593073
Brief Title
Use of Novel Tailored Reminders in Rural Primary Care
Official Title
Use of Novel Tailored Reminders in Rural Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Kansas
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Effective programs are needed that can overcome barriers to CRC screening among persons in rural communities. There is good evidence to suggest that a program employing patient activation and tailoring to address the specific concerns of individuals will be an effective model for addressing CRC screening underutilization for rural residents. In this study, we propose to test such a model among rural primary care patients, a group that has, to date, received little attention. We will also bolster how tailored messaging is traditionally conducted by using a tailored informational flyer format that uses physicians as the message source to increase message saliency. This study will help to assess how a relatively low-cost, disseminable technology can effectively circumvent the "systems problems" endemic in rural primary care. This project will lay the groundwork in practice based research network clinics for future intervention studies which operationalize office and community-based technology to help rural primary care patients make informed health decisions and engage in healthy lifestyle behaviors.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
707 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Tailored Reminder Message
Arm Title
2
Arm Type
Experimental
Arm Description
General Reminder Message
Intervention Type
Behavioral
Intervention Name(s)
Electronic tailored messaging
Intervention Description
Tailored CRC message based on patient screening barriers, preferences and attitudes and reminder to get screened.
Intervention Type
Behavioral
Intervention Name(s)
General Reminder Message
Intervention Description
General CRC health education message and reminder to get screened.
Primary Outcome Measure Information:
Title
Baseline assessment while waiting to see primary care physician and 90-day follow-up telephone survey.
Time Frame
Baseline, 90 Days
Secondary Outcome Measure Information:
Title
Follow-up survey to assess participant discussion of colorectal cancer with their healthcare provider and compliance with CRC screening
Time Frame
90 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly K. Engelman, PhD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

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Use of Novel Tailored Reminders in Rural Primary Care

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