- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00656838
Focusing Implementation to Bring Effective Reminders (FIBER) (FIBER)
February 19, 2014 updated by: Kaiser Permanente
FIBER is 4-year study that will evaluate the implementation of a large-scale population-based colorectal cancer screening patient reminder and coordinated follow-up program.
The CRC screening program began in 2007 with Kaiser Permanente Northwest (KPNW),a not-for- profit, integrated health system in Oregon and Washington.
FIBER consists of 1)a practical randomized controlled trial at the start of the program, followed by 2) a longer-term cohort study as all remaining eligible patients receive the program, and 3)a qualitative evaluation.
FIBER will evaluate the factors that are associated with implementation success across multiple levels: patient, primary care provider (PCP) team, specialists (gastroenterologists, general surgeons, pathologists), and other health plan staff and systems.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
85289
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97227
- Kaiser Permanente Center for Health Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- KPNW members since 2005
- Men and women, aged 50-80 who were due for CRC screening during a 24-month period of time.
Exclusion Criteria:
- KPNW members who were part of a previous quantitative study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: 2
Usual Care
|
|
|
Active Comparator: 1
Patient has had PCP contact (letter, phone call, office visit, educational materials).
|
Behavioral
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To determine the effectiveness and maintenance of a colon-rectal cancer screening patient reminder program.Identify patient, primary care team, and system factors important to implementation success.
Time Frame: Year 2, 3
|
Year 2, 3
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Create, refine, and disseminate an implementation guide for colon-rectal cancer screening reminder programs by combining the findings from the primary aim.
Time Frame: Years 3, 4
|
Years 3, 4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Adrianne C. Feldstein, MD, MS, Kaiser Foundation Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Actual)
April 1, 2011
Study Completion (Actual)
February 1, 2013
Study Registration Dates
First Submitted
April 4, 2008
First Submitted That Met QC Criteria
April 10, 2008
First Posted (Estimate)
April 11, 2008
Study Record Updates
Last Update Posted (Estimate)
February 20, 2014
Last Update Submitted That Met QC Criteria
February 19, 2014
Last Verified
October 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01CA132709-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.