Colloque RI 2014 : Intervention de David W. BAKER, MD, MPH (Feinberg School of Medicine, Northwestern University)

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, MPHMichael A. Gertz Professor in MedicineChief, Division of General Internal Medicine and GeriatricsDeputy Director, Institute for Public Health and MedicineFeinberg School of Medicine, Northwestern University

Intervention Research Against Cancer ConferenceParis, France. November 18th, 2014

Tiffany BrownShira Goldman

David LissKenzie Cameron

Michael Wolf

Ji Young LeeNamratha Kandula

Melissa SimonJoe FeinglassSteve Persell

Erie Family Health CenterThe Alliance of Chicago Community Health Services

This grant was supported by the US Agency for Healthcare Research and Quality (AHRQ), grant number P01-HS021141

I have no financial or non-financial disclosures

Background

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• 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

CRC Screening Rates, Modalities Used, and Racial/Ethnic Disparities

5 Liss DT, Baker DW. Am J Prev Med 2014

Healthy People 2020 Goal: 80%

Healthy People 2020 Goal: 80%

Disparities in CRC Screening by Income

6Liss DT, Baker DW. Am J Prev Med 2014

Expanding Use of FIT May Improve Screening and Decrease Disparities

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• 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 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

Study Aim

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• 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

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

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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

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Initial Outreach

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2-Week Reminder

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3-Month Navigator Call

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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!

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Baker DW, et al. BMC Health Services Research 2013

Low-Literacy FIT Instructions

15 Baker DW, et al. BMC Health Services Research 2013

Results-Participant Characteristics

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Patient CharacteristicIntervention 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 (%)0.29 Latino/Hispanic 197 (87.6) 205 (91.1)

Other 28 (12.4) 20 (8.9)Preferred language (%)

1.0 Spanish 188 (83.6) 188 (83.6) Other 37 (16.4) 37 (16.4)Insurance Status (%)

0.91 Uninsured 174 (77.3) 172 (76.4) 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)

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)

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* 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.

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%)

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* These patients did not receive outreach

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) --- ---

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)*

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*p = 0.04

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

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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

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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

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Thank youContact Information

David W. Baker, MD, MPHMichael A. Gertz Professor in Medicine Chief, Division of General Internal Medicine and GeriatricsDeputy Director, Institute for Public Health and MedicineFeinberg School of Medicine, Northwestern University750 N. Lake Shore Drive, 10th Floor Chicago, IL [email protected]

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25 Cameron KA, Baker DW, et al. JAMA Intern Med 2011

Study Designed to Assess the Marginal Effect of the Personal Calls

3 months