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

This study has been terminated.

(Lack of sufficient participants meeting the eligibility criteria to complete study in proposed and acceptable time frame.)

Sponsor:

Collaborator:

Agency for Healthcare Research and Quality (AHRQ)

Information provided by (Responsible Party):

Kenzie Cameron, Northwestern University

ClinicalTrials.gov Identifier:

NCT00860249

First received: March 11, 2009

Last updated: November 30, 2011

Last verified: November 2011

History of Changes

Results First Received: September 2, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Subject); Primary Purpose: Health Services Research
Condition:	Colorectal Cancer
Interventions:	Behavioral: Letter Only Behavioral: Letter and Educational DVD

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The trial took place at a large urban academic primary care internal medicine practice in Chicago, IL. The trial enrolled patients between March and December 2009.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
We used data contained in the clinic's electronic health record to identify eligible patients. All eligible patients were randomly assigned to one of the three study arms.

Reporting Groups

	Description
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.
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 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.

Participant Flow: Overall Study

	Usual Care	Behavioral: Letter Only	Behavioral: Letter and Educational DVD
STARTED	21	18	21
COMPLETED	0	0	0
NOT COMPLETED	21	18	21
trial was terminated prior to completion	21	18	21

Baseline Characteristics

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Reporting Groups

	Description
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.
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 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.
Total	Total of all reporting groups

Baseline Measures

	Usual Care	Behavioral: Letter Only	Behavioral: Letter and Educational DVD	Total
Number of Participants [units: participants]	21	18	21	60
Age [units: participants]
<=18 years	0	0	0	0
Between 18 and 65 years	21	18	21	60
>=65 years	0	0	0	0
Gender [units: participants]
Female	15	13	14	42
Male	6	5	7	18
Region of Enrollment [units: participants]
United States	21	18	21	60

Outcome Measures

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1. Primary:

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

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2. Secondary:

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

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Measure Type	Secondary
Measure Title	The Secondary Outcome for the Study is the Time to Screening Completion.
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Although 60 individuals were randomized to condition, the trial was halted prior to primary or secondary outcome chart reviews. Hence there are no results to report.

Reporting Groups

	Description
Usual Care	Usual Care - participants receive usual care
Behavioral: Letter Only	Participants in this arm will receive 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.

Measured Values

	Usual Care	Behavioral: Letter Only	Behavioral: Letter and Educational DVD
Number of Participants Analyzed [units: participants]	0	0	0
The Secondary Outcome for the Study is the Time to Screening Completion. [units: participants]

Statistical Analysis 1 for The Secondary Outcome for the Study is the Time to Screening Completion.

Groups ^[1]	All groups
Method ^[2]	Chi-squared
P Value ^[3]	<0.017

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Please note that no analyses were performed as the trial was stopped due to low enrollment.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	We used the Bonferroni calculation to adjust for the planned multiple comparisons among the three groups.

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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:

Name/Title: Kenzie A. Cameron, PhD, MPH
Organization: Northwestern University, Department of General Internal Medicine
phone: 312-503-3910
e-mail: K-Cameron@northwestern.edu

No publications provided

Responsible Party:	Kenzie Cameron, Northwestern University
ClinicalTrials.gov Identifier:	NCT00860249 History of Changes
Other Study ID Numbers:	1R18HS17163-02
Study First Received:	March 11, 2009
Results First Received:	September 2, 2011
Last Updated:	November 30, 2011
Health Authority:	United States: Institutional Review Board

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