NCT00793455

Brief Summary

The purpose of this study is to evaluate whether patient outreach is effective at increasing compliance with preventive screenings ordered by their physician. We hypothesize that educational outreach may increase completion rates.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
628

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2008

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

October 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 19, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

December 1, 2011

Completed
Last Updated

December 1, 2011

Status Verified

October 1, 2011

Enrollment Period

1.1 years

First QC Date

November 17, 2008

Results QC Date

September 1, 2011

Last Update Submit

October 24, 2011

Conditions

Colorectal Cancer ScreeningPrevention & Control

Keywords

educationpreventive servicescreening

Outcome Measures

Primary Outcomes (1)

  • Colorectal Cancer Screening Completion.

    We reviewed electronic health records of participants 3 months post randomization to ascertain outcome. We looked for one or both of the following (1) note in free text MD note documenting receipt of one form of colorectal cancer (CRC) screening during study period (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy. Participants were categorized as completing CRC screening if there was a lab result or physician note located in chart during study period. If no note or lab result was found in chart, then the participant was categorized as not completing CRC screening.

    3 months post randomization

Secondary Outcomes (1)

  • Colorectal Cancer Screening Completion

    6 months post randomization

Study Arms (2)

Intervention Group

EXPERIMENTAL

Received Educational Outreach

Behavioral: Educational outreach

Usual Care Control Group

NO INTERVENTION

Participants in this arm will receive normal care until outcome assessment is performed at 6 months following the placement of the order for the preventive service. They will be sent a letter reminding them to obtain the ordered preventive service test.

Interventions

Educational outreachBEHAVIORAL

Participants will get a letter from their physician that explains that their records show the test has not been completed. The letter will be mailed along with an educational brochure and a DVD about colorectal cancer and colorectal cancer screening.

Intervention Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient's physician has ordered a preventive screening test
  • Patient has not completed this test in 3 months
  • Patient of Northwestern Medical Faculty Foundation General Internal Medicine Clinic.

You may not qualify if:

  • Patient has been given a more recent order for the same screening test.
  • Patient has significant life stress as noted in the Electronic Health Record (EHR)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Medical Faculty Foundation General Internal Medicine Clinic

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

  • Cameron KA, Persell SD, Brown T, Thompson J, Baker DW. Patient outreach to promote colorectal cancer screening among patients with an expired order for colonoscopy: a randomized controlled trial. Arch Intern Med. 2011 Apr 11;171(7):642-6. doi: 10.1001/archinternmed.2010.468. Epub 2010 Dec 13.

    PMID: 21149742RESULT

Limitations and Caveats

This study does not identify the timing of the intervention that would have the most impact. Mailings occurred 3 months or more after the order was placed, contacting patients sooner may have been more effective.

Results Point of Contact

Title
Kenzie A. Cameron, PhD, MPH
Organization
Northwestern University
k-cameron@northwestern.edu
312-503-3910

Study Officials

  • Kenzie A Cameron, PhD, MPH

    Northwestern University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate Professor

Study Record Dates

First Submitted

November 17, 2008

First Posted

November 19, 2008

Study Start

October 1, 2008

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

December 1, 2011

Results First Posted

December 1, 2011

Record last verified: 2011-10

Locations

US(1)