Impact of a Mailed Educational Reminder on Fecal Occult Blood Testing (FOBT): A Randomized Controlled Trial
1 other identifier
interventional
775
1 country
1
Brief Summary
The purpose of our randomized controlled trial is to determine whether mailed educational reminders would increase fecal occult blood test (FOBT) card return rates and, therefore, improve patient compliance with colonrectal cancer (CRC) screening. We will conduct a randomized, controlled trial to evaluate the hypothesis that compliance to FOBT referrals is at least 10% greater among patients who receive mailed educational reminders on the importance of CRC screening. The study will be conducted in Veteran Affairs Medical Center and surrounding VA clinics in San Diego.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2007
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 20, 2007
CompletedFirst Posted
Study publicly available on registry
September 24, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedJuly 17, 2019
July 1, 2019
2.5 years
September 20, 2007
July 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Our primary outcome is FOBT card return rate
6 months
Secondary Outcomes (1)
Predictors of Non-compliance to fecal occult blood testing
6 months
Study Arms (2)
1
EXPERIMENTAL400 patients will be given a mailed educational reminder 10 days after picking up their FOBT cards from the VA laboratory.
2
NO INTERVENTION400 patients will not receive a mailed educational reminder to return their FOBT cards after they have picked up the FOBT cards from the VA laboratory
Interventions
1 page educational reminder that reminds the patient to return their FOBT cards back to the VA laboratory. In addition, it also contains reasons why colon cancer screening is important.
Eligibility Criteria
You may qualify if:
- asymptomatic men and women age 50 years or older who received screening FOBT card kits from the laboratory
You may not qualify if:
- are less than 50 years of age
- are inpatients
- are not undergoing routine colon cancer screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Veteran Affairs Medical Center San Diego
San Diego, California, 92161, United States
Related Publications (2)
Stokamer CL, Tenner CT, Chaudhuri J, Vazquez E, Bini EJ. Randomized controlled trial of the impact of intensive patient education on compliance with fecal occult blood testing. J Gen Intern Med. 2005 Mar;20(3):278-82. doi: 10.1111/j.1525-1497.2005.40023.x.
PMID: 15836533BACKGROUNDLee JK, Reis V, Liu S, Conn L, Groessl EJ, Ganiats TG, Ho SB. Improving fecal occult blood testing compliance using a mailed educational reminder. J Gen Intern Med. 2009 Nov;24(11):1192-7. doi: 10.1007/s11606-009-1087-5. Epub 2009 Sep 23.
PMID: 19774423DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Samuel B Ho, M.D.
UCSD, VA San Diego
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2007
First Posted
September 24, 2007
Study Start
June 1, 2007
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
July 17, 2019
Record last verified: 2019-07