NCT00860249

Brief Summary

The purpose of this study is to evaluate whether patient outreach is effective at increasing compliance with preventative screenings for those patients who, based on national quality standards, have become newly eligible for screening measures. We hypothesize that educational outreach may increase completion rates.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
Completed

Started Mar 2009

Shorter than P25 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 12, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
2 years until next milestone

Results Posted

Study results publicly available

December 1, 2011

Completed
Last Updated

December 5, 2011

Status Verified

November 1, 2011

Enrollment Period

9 months

First QC Date

March 11, 2009

Results QC Date

September 2, 2011

Last Update Submit

November 30, 2011

Conditions

Keywords

educationpreventive servicescreeningColorectal Cancer ScreeningPrevention & Control

Outcome Measures

Primary Outcomes (1)

  • Completion of CRC Screening

    What would have been reported as this Outcome Measure is the number of participants who completed screening. We planned to review electronic health records of participants 6 months post randomization to look for either: (1) note in free text MD note documenting receipt of one form of colorectal cancer (CRC) screening during study period or (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy. Screening completion equaled presence of a lab result or physician note in chart. No patient charts were reviewed due to low accrual.

    6 months from initial contact

Secondary Outcomes (1)

  • The Secondary Outcome for the Study is the Time to Screening Completion.

    6 months after randomization

Study Arms (3)

Usual Care

NO INTERVENTION

Usual Care. Participants in this arm will receive Usual care until outcome assessment is performed at 6 months following randomization. At that time, they will be sent a letter reminding them to obtain the ordered preventative service test, however no further outcomes will be assessed. Thus, during the course of the study, all participants in this arm will have solely received usual care.

Behavioral: Letter Only

EXPERIMENTAL

Behavioral: Letter Only Prior to a scheduled upcoming appointment, participants will get a letter signed by their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening.

Behavioral: Letter Only

Behavioral: Letter and Educational DVD

EXPERIMENTAL

Behavioral: Letter and Educational DVD Participants will get a letter from their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. It will be accompanied by an educational DVD about the screening. The participants will receive this prior to a scheduled upcoming appointment with their physician.

Behavioral: Letter and Educational DVD

Interventions

Letter OnlyBEHAVIORAL

Prior to a scheduled upcoming appointment, participants will get a letter signed by their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening.

Behavioral: Letter Only

Participants will get a letter from their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. It will be accompanied by an educational DVD about the screening. The participants will receive this prior to a scheduled upcoming appointment with their physician.

Behavioral: Letter and Educational DVD

Eligibility Criteria

Age50 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patient of Northwestern Medical Faculty Foundation General Internal Medicine
  • Patient has a scheduled appointment with a GIM physician in the next several weeks
  • Patient will be 50 years old at the time of this appointment
  • Patient is male or female

You may not qualify if:

  • This is the first time the patient is seen in the NMFF GIM clinic
  • There is a prior completion of CRC screening noted in EHR.
  • There is a prior order placed for CRC screening in EHR.
  • Patient has a history of CRC
  • Patient has a diagnosis of ulcerative colitis, inflammatory bowel disease, Crohn's Disease, or documented colectomy.

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

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Early termination prior to collection of primary or secondary outcome measures, hence no analyses of the primary or secondary outcomes were performed.Thus, the only results reported are baseline characteristics of enrolled participants.

Results Point of Contact

Title
Kenzie A. Cameron, PhD, MPH
Organization
Northwestern University, Department of General Internal Medicine

Study Officials

  • Kenzie Cameron, PhD

    Northwestern University, Department of General Internal Medicine

    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

March 11, 2009

First Posted

March 12, 2009

Study Start

March 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

December 5, 2011

Results First Posted

December 1, 2011

Record last verified: 2011-11

Locations