NCT00656838

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85,289

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
Completed

Started Apr 2008

Longer than P75 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

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, 2008

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 11, 2008

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

February 20, 2014

Status Verified

October 1, 2011

Enrollment Period

3 years

First QC Date

April 4, 2008

Last Update Submit

February 19, 2014

Conditions

Keywords

colonrectalcancerscreening

Outcome Measures

Primary Outcomes (1)

  • 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.

    Year 2, 3

Secondary Outcomes (1)

  • Create, refine, and disseminate an implementation guide for colon-rectal cancer screening reminder programs by combining the findings from the primary aim.

    Years 3, 4

Study Arms (2)

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

2

NO INTERVENTION

Usual Care

Interventions

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • KPNW members since 2005
  • Men and women, aged 50-80 who were due for CRC screening during a 24-month period of time.

You may not qualify if:

  • KPNW members who were part of a previous quantitative study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplasms

Interventions

Office Visits

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • Adrianne C. Feldstein, MD, MS

    Kaiser Foundation Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2008

First Posted

April 11, 2008

Study Start

April 1, 2008

Primary Completion

April 1, 2011

Study Completion

February 1, 2013

Last Updated

February 20, 2014

Record last verified: 2011-10

Locations