Comparative Effectiveness of a Multifaceted Intervention to Improve Adherence to Annual Colorectal Cancer Screening in Community Health Centers (RCT) Présentation de David W. Baker au colloque "Recherche interventionnelle contre le cancer : Réunir chercheurs, décideurs et acteurs de terrain » - 17 et 18 novembre 2014, BnF, Paris

1. Northwestern University Feinberg School of Medicine
Comparative Effectiveness of a Multifaceted
Intervention to Improve Adherence to Annual
Colorectal Cancer Screening in Community
Health Centers (RCT)
David W. Baker, MD, MPH
Michael A. Gertz Professor in Medicine
Chief, Division of General Internal Medicine and Geriatrics
Deputy Director, Institute for Public Health and Medicine
Feinberg School of Medicine, Northwestern University
Intervention Research Against Cancer Conference
Paris, France. November 18th, 2014

2. Tiffany Brown
Shira Goldman
David Liss
Kenzie Cameron
Michael Wolf
Ji Young Lee
Namratha Kandula
Melissa Simon
Joe Feinglass
Steve Persell
Erie Family Health Center
The Alliance of Chicago Community Health Services
This grant was supported by the US Agency for Healthcare
Research and Quality (AHRQ), grant number P01-HS021141

3. I have no financial or
non-financial disclosures

4. Background
4
• Colorectal cancer (CRC) is the second most
common cause of cancer death in the U.S.
• Screening can reduce CRC mortality
• US Preventive Services Task Force recommends
one of the following tests for people age 50-75:
• High-sensitivity fecal occult blood testing (FOBT)
annually: fecal immunochemical testing (FIT)
• Flexible sigmoidoscopy every 5 years
• Screening colonoscopy every 10 years
• Unclear which modality is most effective
• Effectiveness depends on quality and adherence

5. CRC Screening Rates, Modalities Used,
and Racial/Ethnic Disparities
Healthy People
2020 Goal: 80%
Healthy People
2020 Goal: 80%
5 Liss DT, Baker DW. Am J Prev Med 2014

6. Disparities in CRC Screening
by Income
6 Liss DT, Baker DW. Am J Prev Med 2014

7. Expanding Use of FIT May Improve
Screening and Decrease Disparities
• About 40% of people say they would prefer FIT
over endoscopy
• Colonoscopy is not available for many people in
the U.S. because of cost or other barriers
• FIT is a less labor-intensive and more cost-effective
7
screening modality
• However, there have been concerns that people
with low income, low education, and/or barriers
to health care access will not be adherent to FIT

8. Study Aim
8
• To determine whether a multifaceted outreach
program could improve adherence to annual FIT
compared to those receiving usual care
• Usual care: 1) point-of-care electronic reminders, 2)
protocols for medical assistants to distribute FIT at
visits, and 3) financial incentives to improve quality
• Targeted a patient population that is mostly
Spanish-speaking Hispanics with low income,
low education, and limited health literacy

9. Methods - Overview
• Study site: Erie Family Health Center, a network
of 7 community clinics in Chicago, Illinois
• Target population: Patients who completed FOBT
in the previous year with a negative test and
would be due for an annual FIT in the next year
• Study design: RCT with an IRB-approved waiver
of informed consent to allow randomization to
intervention vs. usual care true effectiveness
• Primary outcome: completion of FOBT within 6
months of due date
9

10. Intervention
• Used electronic health record (EHR) data to
identify next date each patient was due for FIT
• Due date: initial outreach
• Automated call and text to notify patients they were
due for repeat CRC screening
• Reminder letter mailed with FIT and return envelope
• Low-literacy instructions to complete the FIT
• 2-weeks: reminders by automated phone and
text
• 3-months: CRC screening navigator called
patients and sent second FIT package
10

11. Initial Outreach
11

12. 2-Week Reminder
12

13. 3-Month Navigator Call
13

14. Message Design
• Emphasize that person is still at risk
• Colon cancer can start any time. And when cancer
is starting, you do not feel anything.
• Explain simple, efficacious action to decrease risk
• To protect yourself from colon cancer, you need to
do this test every year. It is time to do the test again.
• The test and postage are free.
• Decrease chance of failure to mail in completed test
• Mail it back to us as soon as you have done the test.
• This simple test could save your life. Do it and send
it in right away!
14
Baker DW, et al. BMC Health Services Research 2013

15. Low-Literacy FIT Instructions
15 Baker DW, et al. BMC Health Services Research 2013

16. Results-Participant Characteristics
16
Patient Characteristic
Intervention Usual Care
p-value
N=225 N=225
Age (mean, SD) 59.5 (6.1) 59.6 (5.7) 0.60
Female (%) 158 (70.2) 164 (72.9) 0.60
Race/ethnicity (%)
Latino/Hispanic 197 (87.6) 205 (91.1) 0.29
Other 28 (12.4) 20 (8.9)
Preferred language (%)
Spanish 188 (83.6) 188 (83.6) 1.0
Other 37 (16.4) 37 (16.4)
Insurance Status (%)
Uninsured 174 (77.3) 172 (76.4) 0.91
Insured 51 (22.7) 53 (23.6)
Chronic medical conditions (%)
0.11
0 81 (36.0) 61 (27.1)
1 73 (32.4) 72 (32.0)
2 58 (25.8) 71 (31.6)
≥ 3 13 (5.8) 21 (9.3)

17. Completion of CRC Screening within
6 Months of Due Date
Intervention
(n=225)
Usual Care
(n=225)
Completed FIT, N (%)* 185 (82.2) 84 (37.3)
Completed colonoscopy, N
6 (2.7) 6 (2.7)
(%)†
Completed either FIT or
colonoscopy, N (%)*
191 (84.9) 90 (40.0)
17
* p < 0.001 by chi-square test
† This does not include patients who had a positive FIT and
subsequently underwent diagnostic colonoscopy. Most patients had
a clinic condition for which a diagnostic colonoscopy was done.

18. Completion of FIT by Time from
Initial Due Date
Time Completed Intervention (n=225) Usual Care (n=225)
Prior to due date* 23 (10.2%) 25 (11.1%)
0-2 weeks 89 (39.6%) 8 (3.6%)
>2 to 13 weeks 54 (24.0%) 27 (12.0%)
>13 to 26 weeks 19 (8.4%) 24 (10.7%)
Total completed 185 (82.2%) 84 (37.3%)
18
* These patients did not receive outreach

19. Receipt of Intervention and
FIT Completion Rates
N (%)
FOBT completed
within 2 weeks (%)
P value
Automated call
Answered in person 86 (38.2) 44 (51.2) REF
Answered by machine 85 (37.8) 36 (42.4) 0.22
Not completed 21 (9.3) 6 (28.6) 0.03
Call not attempted 10 (4.4) 3 (30.0) ---
Done before due date 23 (10.2) --- ---
Text message
Completed 115 (51.1) 51 (44.3) REF
Not completed 87 (38.7) 38 (43.7) 1.0
Done before due date 23 (10.2) --- ---

20. Success of 3-Month Personal
Calls and Rate of FIT Completion
n (%) FIT completed
between 3-6 months
n (%)
CRC Screening Navigator
Spoke with patient
Unable to reach patient
22 (37.3)
37 (62.7)
11 (50.0)
2 (5.4)*
20
*p = 0.04

21. Completion Rate of Colonoscopy
After a Positive FIT Was Low
· Among 29 (11%) patients with positive FIT, 16 (55%)
completed colonoscopy within six months, 6 (21%)
refused, and 7 (24%) still being attempted
· Consistent with previous studies that found low
rates of diagnostic colonoscopy after positive FIT
21

22. Limitations
· Single health system, very strong relationship
with community, high levels of trust
· Only one year of follow-up
· Focused only on repeat screening
· Success of the intervention for getting patients
who have never been screened to complete a
first FIT is much lower
· Unclear whether our results are generalizable to
other racial/ethnic groups
22

23. Conclusions
· It is possible to achieve high adherence to annual
FIT, even among vulnerable patients
· Most of the success can be achieved with low-cost
interventions, but navigator calls still help
· Expanding use of FIT may help increase CRC
screening in the U.S. and decrease disparities
· However, to achieve reductions in mortality, we
must increase the proportion of people with a
positive FIT who complete colonoscopy
23

24. Thank you
Contact Information
David W. Baker, MD, MPH
Michael A. Gertz Professor in Medicine
Chief, Division of General Internal Medicine and Geriatrics
Deputy Director, Institute for Public Health and Medicine
Feinberg School of Medicine, Northwestern University
750 N. Lake Shore Drive, 10th Floor
Chicago, IL 60611
312-503-6407
dbaker1@nmff.org
24

25. Study Designed to Assess the
Marginal Effect of the Personal Calls
3 months
25 Cameron KA, Baker DW, et al. JAMA Intern Med 2011