UPQUAL: Outreach for Patients With Uncompleted Colorectal Cancer Screening Orders

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00793455
• Collaborator: Agency for Healthcare Research and Quality (AHRQ) (U.S. Fed)
• Enrollment: 628
• Location: 1
• Arms: 2
• Duration (Months): 13
• Patients Per Site Per Month: 48.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Screening; Prevention & Control	Behavioral: Educational outreach	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 628 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 1.
• Study Start Date: Oct 1, 2008
• Actual Primary Completion Date: Nov 1, 2009
• Actual Study Completion Date: Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Group Received Educational Outreach	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.
No Intervention: 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.

Outcome Measures

Primary Outcome Measures

1. Colorectal Cancer Screening Completion. [3 months post randomization]

   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.

Secondary Outcome Measures

1. Colorectal Cancer Screening Completion [6 months post randomization]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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 A Cameron, PhD, MPH, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kenzie Cameron, Research Associate Professor, Northwestern University
• ClinicalTrials.gov Identifier: NCT00793455
• Other Study ID Numbers: 1R18HS017163-01
• First Posted: Nov 19, 2008
• Last Update Posted: Dec 1, 2011
• Last Verified: Oct 1, 2011

• Keywords provided by Kenzie Cameron, Research Associate Professor, Northwestern University: education; preventive service; screening
• Additional relevant MeSH terms: Colorectal Neoplasms

Study Results

Participant Flow

Recruitment Details	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 Detail	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.

Arm/Group Title	Intervention Group	Usual Care Control Group
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	314	314
COMPLETED	314	314
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Intervention Group	Usual Care Control Group	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	314	314	628
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.90 (7.1)	58.03 (6.6)	58.0 (6.9)
Sex: Female, Male (Count of Participants)
Female	197 62.7%	192 61.1%	389 61.9%
Male	117 37.3%	122 38.9%	239 38.1%
Race/Ethnicity, Customized (participants) [Number]
White	144 45.9%	132 42%	276 43.9%
Black	79 25.2%	77 24.5%	156 24.8%
Hispanic	9 2.9%	14 4.5%	23 3.7%
Other/unknown	82 26.1%	91 29%	173 27.5%
Region of Enrollment (participants) [Number]
United States	314 100%	314 100%	628 100%
Number of visits in past 2 years (Number) [Number]
1-2	69 22%	79 25.2%	148 23.6%
3	80 25.5%	79 25.2%	159 25.3%
4	54 17.2%	48 15.3%	102 16.2%
>=5	111 35.4%	108 34.4%	219 34.9%
Colorectal Cancer (CRC) screening history (Number) [Number]
Ever screened	22 7%	24 7.6%	46 7.3%
Never screened	292 93%	290 92.4%	582 92.7%
Insurance Status (Number) [Number]
Private	245 78%	236 75.2%	481 76.6%
Medicare	56 17.8%	63 20.1%	119 18.9%
Medicaid	10 3.2%	10 3.2%	20 3.2%
Uninsured	3 1%	5 1.6%	8 1.3%

Outcome Measures

1. Primary Outcome

Title	Colorectal Cancer Screening Completion.
Description	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.
Time Frame	3 months post randomization

Outcome Measure Data

Analysis Population Description

Analysis was based on intention to treat.

Arm/Group Title	Usual Care Control Group	Intervention Group
Arm/Group Description	Usual Care	Received Educational Outreach
Measure Participants	314	314
Did not Complete Screening	304 96.8%	283 90.1%
Completed Screening	10 3.2%	31 9.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care Control Group, Intervention Group
	Comments	We compared the outcomes in the intervention and control groups using rate ratios and chi square test at 3 and 6 months, a 2 sided test with a p value < .05 was used to determine significance. The study was powered to detect a 10-percentage point difference in screening completion between intervention and control groups if the control rate of completion as 20% or less with 80% power.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Rate Ratio
	Estimated Value	3.1
	Confidence Interval	(2-Sided) 95%; 1.5 to 6.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Colorectal Cancer Screening Completion
Description	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.
Time Frame	6 months post randomization

Outcome Measure Data

Analysis Population Description

Analysis was based on intention to treat.

Arm/Group Title	Usual Care Control Group	Intervention Group
Arm/Group Description	Usual Care	Received outreach intervention
Measure Participants	314	314
Completed Screening	38 12.1%	57 18.2%
Did not Complete Screening	276 87.9%	257 81.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care Control Group, Intervention Group
	Comments	Same as primary outcome.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Rate Ratio
	Estimated Value	1.5
	Confidence Interval	(2-Sided) 95%; 1.03 to 2.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Adverse Event Reporting Description	This was a minimal risk trial assessing an educational intervention which was approved by our Institutional Review Board with a waiver of consent. Serious and/or other adverse events were not collected or assessed.
Arm/Group Title	Intervention Group		Usual Care Control Group
Arm/Group Description	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.		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.
All Cause Mortality
	Intervention Group		Usual Care Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Intervention Group		Usual Care Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Intervention Group		Usual Care Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

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

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.