Trial Outcomes & Findings for Strategies and Opportunities to Stop Colon Cancer in Priority Populations (NCT NCT01742065)

NCT ID: NCT01742065

Last Updated: 2019-04-23

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

62155 participants

Primary outcome timeframe

Completed FIT kits sent back within 12 months

Results posted on

2019-04-23

Participant Flow

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.

There were 62,155 participants enrolled in the entire study, but 41,193 in the primary analysis.

Unit of analysis: Clinics

Participant milestones

Participant milestones
Measure	Usual Care 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.	Intervention The intervention consisted of mailed FIT kits, a customized electronic health record (EHR) process and training to support its use.
Overall Study STARTED	20059 13	21134 13
Overall Study COMPLETED	20059 13	21134 13
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

This baseline measure was only assessed in females.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Completed FIT kits sent back within 12 months

Population: 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.

Outcome measures

Outcome measures
Measure	Usual Care n=20059 Participants Usual care clinics continued their standard processes for CRC screening, which typically consisted of providing information and ordering tests during routine clinical encounters.	Intervention n=21134 Participants The intervention consisted of mailed FIT kits, a customized EHR process and training to support its use.
FIT Completion	10.4 Model based percentage of participants Interval 8.1 to 12.8	13.9 Model based percentage of participants Interval 11.3 to 16.5

SECONDARY outcome

Timeframe: Any CRC screening complete within 12 months

Binary indication of any CRC screening (fecal test, sigmoidoscopy, or colonoscopy) during the evaluation interval.

Outcome measures

Outcome measures
Measure	Usual Care n=20059 Participants Usual care clinics continued their standard processes for CRC screening, which typically consisted of providing information and ordering tests during routine clinical encounters.	Intervention n=21134 Participants The intervention consisted of mailed FIT kits, a customized EHR process and training to support its use.
Any CRC Screening	14.5 Percentage completed any CRC screening Interval 12.3 to 16.7	18.3 Percentage completed any CRC screening Interval 15.8 to 20.7

Adverse Events

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gloria D. Coronado

Kaiser Permanente Center for Health Research

Phone: 503 335 2427

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Usual Care n=13 Clinics Usual care clinics continued their standard processes for CRC screening, which typically consisted of providing information and ordering tests during routine clinical encounters	Intervention n=13 Clinics The intervention consisted of mailed FIT kits, a customized electronic health record (EHR) process and training to support its use.	Total n=26 Clinics Total of all reporting groups
Age, Customized Participants aged 50-64	84 percentage of participants n=13 Clinics	80 percentage of participants n=13 Clinics	81 percentage of participants n=26 Clinics
Age, Customized Participants aged 65-75	16 percentage of participants n=13 Clinics	20 percentage of participants n=13 Clinics	19 percentage of participants n=26 Clinics
Sex/Gender, Customized Female	55 percentage of participants n=13 Clinics	56 percentage of participants n=13 Clinics	56 percentage of participants n=26 Clinics
Sex/Gender, Customized Male	45 percentage of participants n=13 Clinics	44 percentage of participants n=13 Clinics	44 percentage of participants n=26 Clinics
Race/Ethnicity, Customized Hispanic	15 percentage of participants n=13 Clinics	8 percentage of participants n=13 Clinics	11 percentage of participants n=26 Clinics
Race/Ethnicity, Customized White	91 percentage of participants n=13 Clinics	93 percentage of participants n=13 Clinics	92 percentage of participants n=26 Clinics
Race/Ethnicity, Customized Non-White, other	5 percentage of participants n=13 Clinics	3 percentage of participants n=13 Clinics	4 percentage of participants n=26 Clinics
Region of Enrollment United States	13 Clinics n=13 Clinics	13 Clinics n=13 Clinics	26 Clinics n=26 Clinics
Language English	86 percentage of participants n=13 Clinics	90 percentage of participants n=13 Clinics	87 percentage of participants n=26 Clinics
Language Spanish	12 percentage of participants n=13 Clinics	4 percentage of participants n=13 Clinics	8 percentage of participants n=26 Clinics
Language Other	1 percentage of participants n=13 Clinics	0 percentage of participants n=13 Clinics	1 percentage of participants n=26 Clinics
Insurance Status Medicaid	35 percentage of participants n=13 Clinics	36 percentage of participants n=13 Clinics	35 percentage of participants n=26 Clinics
Insurance Status Medicare	23 percentage of participants n=13 Clinics	24 percentage of participants n=13 Clinics	23 percentage of participants n=26 Clinics
Insurance Status Uninsured	27 percentage of participants n=13 Clinics	26 percentage of participants n=13 Clinics	26 percentage of participants n=26 Clinics
Insurance Status Commercial	11 percentage of participants n=13 Clinics	10 percentage of participants n=13 Clinics	11 percentage of participants n=26 Clinics
Federal Poverty Level <100 percent	45 percentage of participants n=13 Clinics	47 percentage of participants n=13 Clinics	46 percentage of participants n=26 Clinics
Federal Poverty Level 100-150 percent	18 percentage of participants n=13 Clinics	19 percentage of participants n=13 Clinics	19 percentage of participants n=26 Clinics
Federal Poverty Level 151-200 percent	9 percentage of participants n=13 Clinics	9 percentage of participants n=13 Clinics	9 percentage of participants n=26 Clinics
Federal Poverty Level ≥201percent	10 percentage of participants n=13 Clinics	10 percentage of participants n=13 Clinics	10 percentage of participants n=26 Clinics
Federal Poverty Level Unknown	21 percentage of participants n=13 Clinics	17 percentage of participants n=13 Clinics	17 percentage of participants n=26 Clinics
Physician Visits in past year 1 visit	34 percentage of participants n=13 Clinics	29 percentage of participants n=13 Clinics	33 percentage of participants n=26 Clinics
Physician Visits in past year 2-5 visits	45 percentage of participants n=13 Clinics	46 percentage of participants n=13 Clinics	45 percentage of participants n=26 Clinics
Physician Visits in past year ≥6 visits	19 percentage of participants n=13 Clinics	19 percentage of participants n=13 Clinics	19 percentage of participants n=26 Clinics
% Ever had FIT screening	18 percentage of participants n=13 Clinics	18 percentage of participants n=13 Clinics	18 percentage of participants n=26 Clinics
% with Diabetes (ever)	24 percentage of participants n=13 Clinics	22 percentage of participants n=13 Clinics	22 percentage of participants n=26 Clinics
% with Flu Shot in past year	28 percentage of participants n=13 Clinics	29 percentage of participants n=13 Clinics	29 percentage of participants n=26 Clinics
Proportion of Females with Mammogram in past 2 years	41 percentage of participants n=13 Clinics • This baseline measure was only assessed in females.	39 percentage of participants n=13 Clinics • This baseline measure was only assessed in females.	40 percentage of participants n=26 Clinics • This baseline measure was only assessed in females.
Proportion of Females with Papanicolaou screening in past 3 years	42 percentage of participants n=13 Clinics • This baseline measure was only assessed in females.	42 percentage of participants n=13 Clinics • This baseline measure was only assessed in females.	42 percentage of participants n=26 Clinics • This baseline measure was only assessed in females.