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Focusing Implementation to Bring Effective Reminders (FIBER) (FIBER)

Primary Purpose

Colorectal Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Patients receives letter, phone call, office visit, educational materials

About this trial

This is an interventional screening trial for Colorectal Cancer focused on measuring colon, rectal, cancer, screening

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Kaiser Permanente Center for Health Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Arm Description

Patient has had PCP contact (letter, phone call, office visit, educational materials).

Usual Care

Outcomes

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.

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.

Full Information

NCT ID

NCT00656838

First Posted

April 4, 2008

Last Updated

February 19, 2014

Sponsor

Kaiser Permanente

Collaborators

Oregon Health and Science University, Henry Ford Health System

1. Study Identification

Unique Protocol Identification Number

NCT00656838

Brief Title

Focusing Implementation to Bring Effective Reminders (FIBER)

Acronym

FIBER

Official Title

Focusing Implementation to Bring Effective Reminders (FIBER)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Completed

Study Start Date

April 2008 (undefined)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kaiser Permanente

Collaborators

Oregon Health and Science University, Henry Ford Health System

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

Keywords

colon, rectal, cancer, screening

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

85289 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Patient has had PCP contact (letter, phone call, office visit, educational materials).

Arm Title

Arm Type

No Intervention

Arm Description

Usual Care

Intervention Type

Behavioral

Intervention Name(s)

Patients receives letter, phone call, office visit, educational materials

Intervention Description

Behavioral

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adrianne C. Feldstein, MD, MS

Organizational Affiliation

Kaiser Foundation Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kaiser Permanente Center for Health Research

City

Portland

State/Province

Oregon

ZIP/Postal Code

97227

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Focusing Implementation to Bring Effective Reminders (FIBER)

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