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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00793455
Other study ID # 1R18HS017163-01
Secondary ID
Status Completed
Phase N/A
First received November 17, 2008
Last updated October 24, 2011
Start date October 2008
Est. completion date November 2009

Study information

Verified date October 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 preventive screenings ordered by their physician. We hypothesize that educational outreach may increase completion rates.


Description:

We designed an intervention to focus on patients who have received and accepted a referral for colonoscopy, yet have exhibited some barriers to screening as demonstrated by a lack of screening completion. We conducted a randomized controlled trial to assess the effects of a multicomponent intervention (patient reminder, print and multimedia materials) on colorectal screening completion among this target population.


Recruitment information / eligibility

Status Completed
Enrollment 628
Est. completion date November 2009
Est. primary completion date November 2009
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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)

Study Design

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


Intervention

Behavioral:
Educational outreach
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.

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, 

References & 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/arc — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Colorectal Cancer Screening Completion We reviewed electronic health records of participants 6 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.
6 months post randomization No
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