Testing Interventions to Motivate and Educate
TIME
3 other identifiers
interventional
551
1 country
1
Brief Summary
This study is being done to see if teaching physicians and people who are at least 50 years old and have not been screened within guidelines for colorectal cancer about the importance of colorectal cancer screening will increase screenings for colorectal cancer. The researchers want to understand what ways will work best to motivate and educate both patients and the doctors and nurses who care for them.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable colorectal-cancer
Started Apr 2009
Longer than P75 for not_applicable colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 19, 2012
CompletedFirst Posted
Study publicly available on registry
April 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2013
CompletedApril 28, 2020
April 1, 2020
4.8 years
March 19, 2012
April 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants who undergo colorectal screening because of interventions
The effectiveness of clinic-directed interventions in encouraging subjects to undergo colorectal cancer screening in the 5 intervention clinics in the first 12 months will be assessed. The subjects who did not undergo colorectal cancer screening during that year will then undergo patient-directed intervention for up to a year. The effectiveness of both of these types of intervention will be compared to the control clinics where there is no intervention.
Up to 3 and a half years
Secondary Outcomes (1)
Number of problems associated with intervention program
Up to 3 and half years
Study Arms (2)
Intervention Clinics
ACTIVE COMPARATORSubjects recruited at the Intervention Clinics will first be provided with Clinic-directed interventions(Clinic-directed intervention program)including: 1)provider-directed interventions; 2)office-based systems; and 3) waiting room materials. If the subjects have not undergone colorectal cancer screening after 12 months, they will be provided with an individual patient-directed program consisting of the following stepped interventions: 1) tailored physician letter, easy-to-read educational materials, and an fecal occult blood test (FOBT)information sheet and card; 2) telephone counseling for those who do not respond to the letter; and 3) home visits by lay health advisors for those who do not respond to the letter or phone counseling.
Usual Care Clinics
NO INTERVENTIONSubjects recruited at the Usual Care Clinics (Control Clinics) will not receive any study intervention. The results of how many subjects undergo colorectal cancer screening at the Usual Care Clinics will be compared to the number that undergo colorectal cancer screening at the Intervention Clinics.
Interventions
Clinic-directed intervention program: Subjects recruited at the Intervention Clinics will first be provided with Clinic-directed interventions including: 1)provider-directed interventions (computerized case-based education, evidence-based guidelines, ask the expert; 2)office-based systems (risk assessment forms, procedure monitoring, follow-up protocol, audit with feedback, chart reminders); and 3) waiting room materials.
If the subjects have not undergone colorectal cancer screening within 12 months of receiving the clinic-directed program, they will be provided with an individual patient-directed program consisting of the following stepped interventions: 1) tailored physician letter, easy-to-read educational materials, and an fecal occult blood test (FOBT)information sheet and card; 2) telephone counseling for those who do not respond to the letter; and 3) home visits by lay health advisors for those who do not respond to the letter or phone counseling.
Eligibility Criteria
You may qualify if:
- Age 50 or older
- No prior history of familial/hereditary cancer syndrome (e.g. hereditary non-polyposis colon cancer), polyps, or inflammatory bowel disease (e.g. Crohn's disease)
- Have a current phone number
- Have had 2 or more visits to the Family Practice or General Internal Medicine Clinics in the past 2 years
- Have a current address in records and no definite plans to move within the next year
- Be at average risk for colorectal cancer
- Be in good health as judged by their primary care doctor
- Not be over the age of 85
You may not qualify if:
- Less than 50 years old
- Greater than 85 years old
- History of familial/hereditary cancer syndrome, polyps, or Crohn's disease
- History of contraindications to colorectal cancer screening, such as congenital heart failure, renal failure, dementia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43201, United States
Related Publications (1)
Murray DM, Katz ML, Post DM, Pennell ML, Young GS, Tatum CM, Paskett ED. Enhancing cancer screening in primary care: rationale, design, analysis plan, and recruitment results. Contemp Clin Trials. 2013 Mar;34(2):356-63. doi: 10.1016/j.cct.2013.01.003. Epub 2013 Jan 26.
PMID: 23357561DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Electra D. Paskett, PhD
The Ohio State University Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 19, 2012
First Posted
April 2, 2012
Study Start
April 1, 2009
Primary Completion
December 31, 2013
Study Completion
December 31, 2013
Last Updated
April 28, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share