Outreach for Patients With Uncompleted Colorectal Cancer Screening Orders (UPQUAL)

This study has been completed.

Sponsor:

Collaborator:

Agency for Healthcare Research and Quality (AHRQ)

Information provided by (Responsible Party):

Kenzie Cameron, Northwestern University

ClinicalTrials.gov Identifier:

NCT00793455

First received: November 17, 2008

Last updated: October 24, 2011

Last verified: October 2011

History of Changes

Results First Received: September 1, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single Blind (Participant); Primary Purpose: Health Services Research
Conditions:	Colorectal Cancer Screening Prevention & Control
Intervention:	Behavioral: Educational outreach

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
This trial took place at a large urban academic primary care internal medicine practice in Chicago, IL. This trial was enrolling patients between October 2008 and May 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 in equal numbers to either the control or intervention arms. All eligible patients were randomized and assigned to groups until we reached target study size.

Reporting Groups

	Description
Intervention Group	Participants assigned to this group received a one-time educational intervention within one week of randomization. Educational intervention consisted of a letter from patient's physician, a brochure about colorectal cancer screening, and a DVD about colorectal cancer screening.
Usual Care Control Group	Participants in this arm will receive normal care until outcome assessment is performed at 6 months following the placement of the order for the preventive service. They will be sent a letter reminding them to obtain the ordered preventive service test.

Participant Flow: Overall Study

	Intervention Group	Usual Care Control Group
STARTED	314	314
COMPLETED	314	314
NOT COMPLETED	0	0

Baseline Characteristics

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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.
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Reporting Groups

	Description
Intervention Group	Participants assigned to this group received a one-time educational intervention within one week of randomization. Educational intervention consisted of a letter from patient's physician, a brochure about colorectal cancer screening, and a DVD about colorectal cancer screening.
Usual Care Control Group	Participants in this arm will receive normal care until outcome assessment is performed at 6 months following the placement of the order for the preventive service. They will be sent a letter reminding them to obtain the ordered preventive service test.
Total	Total of all reporting groups

Baseline Measures

	Intervention Group	Usual Care Control Group	Total
Overall Participants Analyzed [Units: Participants]	314	314	628

Age [Units: Years] Mean (Standard Deviation)	57.90 (7.1)	58.03 (6.6)	58.0 (6.9)

Gender [Units: Participants]
Female	197	192	389
Male	117	122	239

Race/Ethnicity, Customized [Units: Participants]
White	144	132	276
Black	79	77	156
Hispanic	9	14	23
Other/unknown	82	91	173

Region of Enrollment [Units: Participants]
United States	314	314	628

Number of visits in past 2 years [Units: Participants]
1-2	69	79	148
3	80	79	159
4	54	48	102
>=5	111	108	219

Colorectal Cancer (CRC) screening history [Units: Participants]
Ever screened	22	24	46
Never screened	292	290	582

Insurance Status [Units: Participants]
Private	245	236	481
Medicare	56	63	119
Medicaid	10	10	20
Uninsured	3	5	8

Outcome Measures

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1. Primary:

Colorectal Cancer Screening Completion. [ Time Frame: 3 months post randomization ]

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2. Secondary:

Colorectal Cancer Screening Completion [ Time Frame: 6 months post randomization ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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
This study does not identify the timing of the intervention that would have the most impact. Mailings occurred 3 months or more after the order was placed, contacting patients sooner may have been more effective.

More Information

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Certain Agreements:

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

Results Point of Contact:

Name/Title: Kenzie A. Cameron, PhD, MPH
Organization: Northwestern University
phone: 312-503-3910
e-mail: k-cameron@northwestern.edu

Publications of Results:

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/archinternmed.2010.468. Epub 2010 Dec 13.

Responsible Party:	Kenzie Cameron, Northwestern University
ClinicalTrials.gov Identifier:	NCT00793455 History of Changes
Other Study ID Numbers:	1R18HS017163-01 ( US NIH Grant/Contract Award Number )
Study First Received:	November 17, 2008
Results First Received:	September 1, 2011
Last Updated:	October 24, 2011

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