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Strategies and Opportunities to Stop Colon Cancer in Priority Populations (STOPCRC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01742065
Recruitment Status : Completed
First Posted : December 5, 2012
Results First Posted : April 23, 2019
Last Update Posted : April 23, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Kaiser Permanente

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Screening
Condition Colorectal Cancer
Intervention Other: Auto Plus
Enrollment 62155
Recruitment Details This cluster randomized pragmatic clinical trial was conducted in 26 federally qualified health center clinics, representing 8 health centers in Oregon & California, randomized to intervention (n = 13) or usual care (n = 13). All participants were overdue for colorectal cancer (CRC) screening at some point during accrual interval 2.4.2014-2.3.2015.
Pre-assignment Details There were 62,155 participants enrolled in the entire study, but 41,193 in the primary analysis.
Arm/Group Title Usual Care Intervention
Hide Arm/Group Description Usual care clinics continued their standard processes for CRC screening, which typically consisted of providing information and ordering tests during routine clinical encounters. Usual Care clinics were offered training and intervention materials in August 2015. The intervention consisted of mailed FIT kits, a customized electronic health record (EHR) process and training to support its use.
Period Title: Overall Study
Number of participants Number of units (Clinics) Number of participants Number of units (Clinics)
Started 20059 [1] 13 21134 [2] 13
Completed 20059 [1] 13 21134 [2] 13
Not Completed 0 0 0 0
[1]
20059 patients were analyzed in 13 clinics.
[2]
21134 patients were analyzed in 13 clinics.
Arm/Group Title Usual Care Intervention Total
Hide Arm/Group Description Usual care clinics continued their standard processes for CRC screening, which typically consisted of providing information and ordering tests during routine clinical encounters The intervention consisted of mailed FIT kits, a customized electronic health record (EHR) process and training to support its use. Total of all reporting groups
Overall Number of Baseline Participants 20059 21134 41193
Overall Number of Units Analyzed
Type of Units Analyzed: Clinics
13 13 26
Hide Baseline Analysis Population Description
The baseline analysis was conducted at the clinic level
Age, Customized   [1] 
Median (Full Range)
Unit of measure:  Percentage of participants
Number Analyzed 13 Clinics 13 Clinics 26 Clinics
Participants aged 50-64
84
(73 to 88)
80
(73 to 86)
81
(73 to 88)
Participants aged 65-75
16
(12 to 27)
20
(14 to 27)
19
(12 to 27)
[1]
Measure Description: Reported range reflects the range of clinic proportions.
Sex/Gender, Customized   [1] 
Median (Full Range)
Unit of measure:  Percentage of participants
Number Analyzed 13 Clinics 13 Clinics 26 Clinics
Female
55
(49 to 65)
56
(43 to 62)
56
(43 to 65)
Male
45
(35 to 51)
44
(38 to 57)
44
(35 to 57)
[1]
Measure Description: Reported range reflects the range of clinic proportions.
Race/Ethnicity, Customized   [1] 
Median (Full Range)
Unit of measure:  Percentage of participants
Hispanic Number Analyzed 13 Clinics 13 Clinics 26 Clinics
15
(2 to 36)
8
(1 to 33)
11
(1 to 36)
[1]
Measure Description: Data represent the proportion of Hispanic study participants across the individual clinics. Reported range reflects the range of clinic proportions.
Race/Ethnicity, Customized   [1] 
Median (Full Range)
Unit of measure:  Percentage of participants
Number Analyzed 13 Clinics 13 Clinics 26 Clinics
White
91
(67 to 96)
93
(50 to 97)
92
(50 to 97)
Non-White, other
5
(2 to 28)
3
(1 to 40)
4
(1 to 40)
[1]
Measure Description: Data represent the proportion of study participants by race (categories: white and non-white, other) across the individual clinics. Reported range reflects the range of clinic proportions.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Clinics
United States Number Analyzed 13 Clinics 13 Clinics 26 Clinics
13 13 26
Language   [1] 
Median (Full Range)
Unit of measure:  Percentage of participants
Number Analyzed 13 Clinics 13 Clinics 26 Clinics
English
86
(53 to 99)
90
(41 to 99)
87
(41 to 99)
Spanish
12
(1 to 31)
4
(0 to 26)
8
(0 to 31)
Other
1
(0 to 18)
0
(0 to 48)
1
(0 to 48)
[1]
Measure Description: Data represent the proportion of study participants by preferred language across the individual clinics. Reported range reflects the range of clinic proportions.
Insurance Status   [1] 
Median (Full Range)
Unit of measure:  Percentage of participants
Number Analyzed 13 Clinics 13 Clinics 26 Clinics
Medicaid
35
(25 to 54)
36
(20 to 51)
35
(20 to 54)
Medicare
23
(15 to 36)
24
(20 to 37)
23
(15 to 37)
Uninsured
27
(2 to 38)
26
(3 to 40)
26
(2 to 40)
Commercial
11
(1 to 39)
10
(1 to 49)
11
(1 to 49)
[1]
Measure Description: Data represent the proportion of study participants by Insurance status across the individual clinics. Reported range reflects the range of clinic proportions.
Federal Poverty Level   [1] 
Median (Full Range)
Unit of measure:  Percentage of participants
Number Analyzed 13 Clinics 13 Clinics 26 Clinics
<100 percent
45
(19 to 64)
47
(13 to 61)
46
(13 to 64)
100-150 percent
18
(14 to 24)
19
(6 to 31)
19
(6 to 31)
151-200 percent
9
(5 to 13)
9
(2 to 14)
9
(2 to 14)
≥201percent
10
(2 to 36)
10
(3 to 26)
10
(2 to 36)
Unknown
21
(1 to 36)
17
(3 to 76)
17
(1 to 76)
[1]
Measure Description:

Data represent the proportion of study participants by federal poverty stratification across the individual clinics. Reported range reflects the range of clinic proportions.

  • <100 represents a household income below the federal poverty level
  • 100-150 represents a household income between 100-150% of the federal poverty level, and so on
Physician Visits in past year   [1] 
Median (Full Range)
Unit of measure:  Percentage of participants
Number Analyzed 13 Clinics 13 Clinics 26 Clinics
1 visit
34
(23 to 44)
29
(21 to 48)
33
(21 to 48)
2-5 visits
45
(41 to 49)
46
(40 to 55)
45
(40 to 55)
≥6 visits
19
(10 to 31)
19
(9 to 33)
19
(9 to 33)
[1]
Measure Description: Data represent the proportion of study participants by number of physician visits in past year across the individual clinics. Reported range reflects the range of clinic proportions.
% Ever had FIT screening   [1] 
Median (Full Range)
Unit of measure:  Percentage of participants
Number Analyzed 13 Clinics 13 Clinics 26 Clinics
18
(8 to 39)
18
(8 to 53)
18
(8 to 53)
[1]
Measure Description: Data represent the portion of study participants who have ever had FIT screening across the individual clinics. Reported range reflects the range of clinic proportions.
% with Diabetes (ever)   [1] 
Median (Full Range)
Unit of measure:  Percentage of participants
Number Analyzed 13 Clinics 13 Clinics 26 Clinics
24
(14 to 30)
22
(13 to 29)
22
(13 to 30)
[1]
Measure Description: Data represent the portion of study participants with diabetes diagnosis across the individual clinics. Reported range reflects the range of clinic proportions.
% with Flu Shot in past year   [1] 
Median (Full Range)
Unit of measure:  Percentage of participants
Number Analyzed 13 Clinics 13 Clinics 26 Clinics
28
(10 to 40)
29
(13 to 37)
29
(10 to 40)
[1]
Measure Description: Data represent the portion of study participants with flu shot in the past year across the individual clinics. Reported range reflects the range of clinic proportions.
Proportion of Females with Mammogram in past 2 years   [1] [2] 
Median (Full Range)
Unit of measure:  Percentage of participants
Number Analyzed 13 Clinics [3]  13 Clinics [4]  26 Clinics [5] 
41
(24 to 59)
39
(16 to 57)
40
(16 to 59)
[1]
Measure Description: Data represent the proportion of female study participants with a mammogram in the past 2 years across the individual clinics. Reported range reflects the range of clinic proportions. *The percentages are based only on women in the 26 clinics. These data represent the median proportion of women in a clinic with a mammogram.
[2]
Measure Analysis Population Description: This baseline measure was only assessed in females.
[3]
11368 participants
[4]
11626 participants
[5]
22994 participants
Proportion of Females with Papanicolaou screening in past 3 years   [1] [2] 
Median (Full Range)
Unit of measure:  Percentage of participants
Number Analyzed 13 Clinics [3]  13 Clinics [4]  26 Clinics [5] 
42
(31 to 54)
42
(15 to 60)
42
(15 to 60)
[1]
Measure Description:

Data represent the proportion of female study participants with papanicolaou screening in past 3 years across the individual clinics. Reported range reflects the range of clinic proportions.

*The percentages are based only on women in the 26 clinics. These data represent the median proportion of women in a clinic with papanicolaou screening.

[2]
Measure Analysis Population Description: This baseline measure was only assessed in females.
[3]
11368 participants
[4]
11626 participants
[5]
22994 participants
1.Primary Outcome
Title FIT Completion
Hide Description Binary indication of FIT completion within 12 months or through August 3, 2015 (when usual care clinics received access to study tools). Proportion of completed FIT is represented below with a confidence interval of the difference in completed FIT.
Time Frame Completed FIT kits sent back within 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Adult, age 50 to 74 years, clinic visit within 12 months of accrual, and due for CRC screening; no EHR evidence of completed FIT in past 11 months, flexible sigmoidoscopy in past 4 years, colonoscopy in past 9 years, an order for FIT in past 6 months or referral for sigmoidoscopy or colonoscopy in past year.
Arm/Group Title Usual Care Intervention
Hide Arm/Group Description:
Usual care clinics continued their standard processes for CRC screening, which typically consisted of providing information and ordering tests during routine clinical encounters.
The intervention consisted of mailed FIT kits, a customized EHR process and training to support its use.
Overall Number of Participants Analyzed 20059 21134
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Model based percentage of participants
10.4
(8.1 to 12.8)
13.9
(11.3 to 16.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, Intervention
Comments [Not Specified]
Type of Statistical Test Superiority
Comments To assess effectiveness, we fit generalized estimating equations (GEE) with a logistic link to model patient-level data. We weighted patient data so that each clinic's data had an equal weight. Models were adjusted for age, sex, and health center. They used robust variance estimators and independent correlation structures. We specified clinic as a clustering variable to account for intraclinic correlation; the intraclinic correlation coefficient was 0.05 after model covariates adjustment.
Statistical Test of Hypothesis P-Value .05
Comments We report effectiveness as the absolute difference between intervention and usual care clinics in adjusted probabilities calculated using mean values for all covariates;
Method Generalized Estimating Equations (GEE)
Comments Reported P values based on the corresponding adjusted odds ratio and account for reduced degrees of freedom owing to clustering.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.4
Confidence Interval (2-Sided) 95%
.1 to 6.8
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Any CRC Screening
Hide Description Binary indication of any CRC screening (fecal test, sigmoidoscopy, or colonoscopy) during the evaluation interval.
Time Frame Any CRC screening complete within 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Adult, age 50 to 74 years, clinic visit within 12 months of accrual, and due for CRC screening; no EHR evidence of completed FIT in past 11 months, flexible sigmoidoscopy in past 4 years, colonoscopy in past 9 years, an order for FIT in past 6 months or referral for sigmoidoscopy or colonoscopy in past year.
Arm/Group Title Usual Care Intervention
Hide Arm/Group Description:
Usual care clinics continued their standard processes for CRC screening, which typically consisted of providing information and ordering tests during routine clinical encounters.
The intervention consisted of mailed FIT kits, a customized EHR process and training to support its use.
Overall Number of Participants Analyzed 20059 21134
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percentage completed any CRC screening
14.5
(12.3 to 16.7)
18.3
(15.8 to 20.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, Intervention
Comments [Not Specified]
Type of Statistical Test Other
Comments To assess effectiveness, we fit generalized estimating equations (GEE) with a logistic link to model patient-level data. We weighted patient data so that each clinic's data had an equal weight. Models were adjusted for age, sex, and health center. They used robust variance estimators and independent correlation structures. We specified clinic as a clustering variable to account for intraclinic correlation; the intraclass correlation coefficient was 0.05 after covariable adjustment.
Statistical Test of Hypothesis P-Value .02
Comments We report effectiveness as the absolute difference between intervention and usual care clinics in adjusted probabilities calculated using mean values for all covariates;
Method Generalized Estimating Equations (GEE)
Comments Reported P values based on the corresponding adjusted odds ratio and account for reduced degrees of freedom owing to clustering.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.8
Confidence Interval (2-Sided) 95%
.6 to 7
Estimation Comments [Not Specified]
Time Frame 2.4.2014-8.4.2018, 4.5 years
Adverse Event Reporting Description As our intervention mailed FIT kits to eligible patients (and our primary outcome was completion of FIT), we did not have a systematic way of capturing Severe Adverse Events. Nevertheless, we agreed to document and report to our Data Safety Monitoring Board any Severe Adverse Events we learned about anecdotally from participating clinics, of which there were none.
 
Arm/Group Title Usual Care Intervention
Hide Arm/Group Description Usual care clinics continued their standard processes for CRC screening, which typically consisted of providing information and ordering tests during routine clinical encounters. Usual Care clinics were offered training and intervention materials in August 2015, and therefore patients were followed through the end of the study. The intervention consisted of mailed FIT kits, a customized EHR process and training to support its use. All patients were followed through the end of the study.
All-Cause Mortality
Usual Care Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20059 (0.00%)   0/21134 (0.00%) 
Hide Serious Adverse Events
Usual Care Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20059 (0.00%)   0/21134 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Usual Care Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20059 (0.00%)   0/21134 (0.00%) 
  • FIT samples were not processed if missing collection dates
  • under-capture of colonoscopy
  • screening/diagnostic colonoscopy indistinguishable
  • mailed an introduction letter and having a FIT order served as proxy for having been mailed a FIT.
Certain Agreements
Principal Investigators are NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gloria D. Coronado
Organization: Kaiser Permanente Center for Health Research
Phone: 503 335 2427
EMail: Gloria.D.Coronado@kpchr.org
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT01742065    
Other Study ID Numbers: UH3CA188640 ( U.S. NIH Grant/Contract )
1UH2AT007782-01 ( U.S. NIH Grant/Contract )
First Submitted: December 3, 2012
First Posted: December 5, 2012
Results First Submitted: October 25, 2018
Results First Posted: April 23, 2019
Last Update Posted: April 23, 2019