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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00860249
Other study ID # 1R18HS17163-02
Secondary ID
Status Terminated
Phase N/A
First received March 11, 2009
Last updated November 30, 2011
Start date March 2009
Est. completion date December 2009

Study information

Verified date November 2011
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 60
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 50 Years to 50 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States Northwestern Medical Faculty Foundation General Internal Medicine Clinic Chicago Illinois

Sponsors (2)

Lead Sponsor Collaborator
Northwestern University Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary The Secondary Outcome for the Study is the Time to Screening Completion. This Outcome Measure would have reported the length of time, measured in days, that occurred between the date of randomization and the completed screening date. We planned to review the 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 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 after randomization No
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