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

Primary Purpose

Colorectal Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Letter Only
Letter and Educational DVD
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Colorectal Cancer focused on measuring education, preventive service, screening, Colorectal Cancer Screening, Prevention & Control

Eligibility Criteria

50 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Northwestern Medical Faculty Foundation General Internal Medicine Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Usual Care

Behavioral: Letter Only

Behavioral: Letter and Educational DVD

Arm Description

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 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 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 11, 2009
Last Updated
November 30, 2011
Sponsor
Northwestern University
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
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1. Study Identification

Unique Protocol Identification Number
NCT00860249
Brief Title
Outreach for Patients That Are Newly Eligible for Colorectal Cancer Screening
Acronym
UPQUAL
Official Title
Using Precision Performance Measurement To Conduct Focused Quality Improvement. Sub-study 2
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Terminated
Why Stopped
Lack of sufficient participants meeting the eligibility criteria to complete study in proposed and acceptable time frame.
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
education, preventive service, screening, Colorectal Cancer Screening, Prevention & Control

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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.
Arm Title
Behavioral: Letter Only
Arm Type
Experimental
Arm Description
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.
Arm Title
Behavioral: Letter and Educational DVD
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Letter Only
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Letter and Educational DVD
Intervention Description
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.
Primary Outcome Measure Information:
Title
Completion of CRC Screening
Description
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.
Time Frame
6 months from initial contact
Secondary Outcome Measure Information:
Title
The Secondary Outcome for the Study is the Time to Screening Completion.
Description
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.
Time Frame
6 months after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenzie Cameron, PhD
Organizational Affiliation
Northwestern University, Department of General Internal Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Medical Faculty Foundation General Internal Medicine Clinic
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Outreach for Patients That Are Newly Eligible for Colorectal Cancer Screening

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