Outreach for Patients That Are Newly Eligible for Colorectal Cancer Screening (UPQUAL)

• ClinicalTrials.gov Identifier: NCT00860249
• Recruitment Status: Terminated
• First Posted: March 12, 2009
• Results First Posted: December 1, 2011
• Last Update Posted: December 5, 2011
• Sponsor: Northwestern University
• Collaborator: Agency for Healthcare Research and Quality (AHRQ)
• Information provided by (Responsible Party): Kenzie Cameron, Northwestern University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Colorectal Cancer	Behavioral: Letter Only; Behavioral: Letter and Educational DVD	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Health Services Research
• Official Title: Using Precision Performance Measurement To Conduct Focused Quality Improvement. Sub-study 2
• Study Start Date: March 2009
• Actual Primary Completion Date: December 2009
• Actual Study Completion Date: December 2009

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Usual Care; 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.
Experimental: Behavioral: Letter Only; 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; 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.
Experimental: Behavioral: Letter and Educational DVD; 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; 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.

Outcome Measures

Primary Outcome Measures :

1. Completion of CRC Screening [ Time Frame: 6 months from initial contact ]
   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.

Secondary Outcome Measures :

1. The Secondary Outcome for the Study is the Time to Screening Completion. [ Time Frame: 6 months after randomization ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 50 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Illinois

Northwestern Medical Faculty Foundation General Internal Medicine Clinic

Chicago, Illinois, United States, 60611

Sponsors and Collaborators

Northwestern University

Agency for Healthcare Research and Quality (AHRQ)

Investigators

• Principal Investigator: Kenzie Cameron, PhD; Northwestern University, Department of General Internal Medicine

More Information

• Responsible Party: Kenzie Cameron, Research Associate Professor, Northwestern University
• ClinicalTrials.gov Identifier: NCT00860249
• Other Study ID Numbers: 1R18HS017163-02 ( U.S. AHRQ Grant/Contract )
• First Posted: March 12, 2009
• Results First Posted: December 1, 2011
• Last Update Posted: December 5, 2011
• Last Verified: November 2011

Keywords provided by Kenzie Cameron, Northwestern University:

education; preventive service; screening; Colorectal Cancer Screening; Prevention & Control

Additional relevant MeSH terms:

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases