Focusing Implementation to Bring Effective Reminders (FIBER) - Full Text View

Sponsors and Collaborators:	Kaiser Permanente Oregon Health and Science University Henry Ford Health System
Information provided by:	Kaiser Permanente
ClinicalTrials.gov Identifier:	NCT00656838

Purpose

FIBER is 4-year study that will evaluate the implementation of a large-scale popuulation-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 helth 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.

Condition	Intervention
Colorectal Cancer	Behavioral: Patients receives letter, phone call, office visit, educational materials

MedlinePlus related topics: Cancer Colorectal Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Screening, Randomized, Single Blind (Subject), Uncontrolled, Parallel Assignment
Official Title:	Focusing Implementation to Bring Effective Reminders (FIBER)

Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	44000
Study Start Date:	April 2008
Estimated Study Completion Date:	March 2012
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Patient has had PCP contact (letter, phone call, office visit, educational materials).	Behavioral: Patients receives letter, phone call, office visit, educational materials Behavioral
2: No Intervention Usual Care

Eligibility

Ages Eligible for Study:	50 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00656838

Locations

United States, Oregon
Kaiser Permanente Center for Health Research
Portland, Oregon, United States, 97227

Sponsors and Collaborators

Kaiser Permanente

Oregon Health and Science University

Henry Ford Health System

Investigators

Principal Investigator:

Adrianne C. Feldstein, MD, MS

Kaiser Foundation Hospital

More Information

Responsible Party:	Northwest Permanente ( Adrianne C. Feldstein, MD, MS )
Study ID Numbers:	R01 CA132709-01, R01 CA132709-01
Study First Received:	April 4, 2008
Last Updated:	November 11, 2008
ClinicalTrials.gov Identifier:	NCT00656838
Health Authority:	United States: Institutional Review Board

Keywords provided by Kaiser Permanente:

colon
rectal
cancer
screening

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Neoplasms

Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009