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Research ArticleOriginal Research

A Randomized Controlled Trial to Improve Colon Cancer Screening in Rural Family Medicine: An Iowa Research Network (IRENE) Study

Barcey T. Levy, Yinghui Xu, Jeanette M. Daly and John W. Ely
The Journal of the American Board of Family Medicine September 2013, 26 (5) 486-497; DOI: https://doi.org/10.3122/jabfm.2013.05.130041
Barcey T. Levy
From the Department of Family Medicine, Roy J. and Lucille A. Carver College of Medicine (BTL, YX, JMD, JWE), and the Department of Epidemiology, College of Public Health (BTL), University of Iowa, Iowa City.
PhD, MD
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Yinghui Xu
From the Department of Family Medicine, Roy J. and Lucille A. Carver College of Medicine (BTL, YX, JMD, JWE), and the Department of Epidemiology, College of Public Health (BTL), University of Iowa, Iowa City.
MS
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Jeanette M. Daly
From the Department of Family Medicine, Roy J. and Lucille A. Carver College of Medicine (BTL, YX, JMD, JWE), and the Department of Epidemiology, College of Public Health (BTL), University of Iowa, Iowa City.
PhD, RN
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John W. Ely
From the Department of Family Medicine, Roy J. and Lucille A. Carver College of Medicine (BTL, YX, JMD, JWE), and the Department of Epidemiology, College of Public Health (BTL), University of Iowa, Iowa City.
MD, MSPH
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Article Figures & Data

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    Figure 1.

    Flow of patients through the colorectal cancer screening trial. IRENE, Iowa Research Network; FIT, fecal immunochemical test.

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    Figure 2.

    Colorectal cancer screening (CRC) reminder.

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    Figure 3.

    Iowans Get Screened magnet.

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    Figure 4.

    A: Cumulative percentage screened with any method by study group. B: Cumulative percentage screened with fecal immunochemical test (FIT) or colonoscopy (CS) by study group.

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    Table 1. Demographics and Baseline Characteristics (n=743)*
    VariablesUsual Care (n=185)Physician Chart Reminder (n=185)Mailed Education/FIT (n=186)Mailed Education + Phone Call (n=187)
    Age (years)
        <65136 (73.5)131 (70.8)131 (70.4)136 (72.7)
        ≥6549 (26.5)54 (29.2)55 (29.6)51 (27.3)
    Female sex99 (53.5)94 (50.8)97 (52.2)96 (51.3)
    Marital status
        Single27 (14.6)34 (18.4)26 (14.0)27 (14.4)
        Married145 (78.4)135 (73.0)143 (76.9)148 (79.1)
        Widowed13 (7.0)14 (7.6)17 (9.1)11 (5.9)
        Unknown0 (0)2 (1.1)0 (0)1 (0.5)
    Hispanic ethnicity3 (1.6)2 (1.1)2 (1.1)1 (0.5)
    Race
        White182 (98.4)182 (98.4)183 (98.4)186 (99.5)
        Black2 (1.1)0 (0)2 (1.1)0 (0)
        Asian0 (0)0 (0)1 (0.5)0 (0)
        Other/unknown1 (0.5)3 (1.6)0 (0)1 (0.5)
    Educational level
        High school or less61 (33.0)69 (37.3)68 (36.6)75 (40.1)
        Some college or more123 (66.5)112 (60.5)117 (62.9)111 (59.4)
        Unknown1 (0.5)4 (2.2)1 (0.5)1 (0.5)
    Uninsured6 (3.2)14 (7.6)18 (9.7)13 (7.0)
    Annual income ($)
        <40,00072 (38.9)61 (33.0)69 (37.1)71 (38.0)
        40,000-<80,00079 (42.7)83 (44.9)81 (43.5)76 (40.6)
        ≥$80,00023 (12.4)24 (13.0)26 (14.0)31 (16.6)
        Unknown11 (6.0)17 (9.2)10 (5.4)9 (4.8)
    Rural resident156 (84.3)152 (82.2)151 (81.2)150 (80.2)
    Family history
        Immediate family member13 (7.0)19 (10.3)22 (11.8)24 (12.9)
        More distant relative23 (12.4)18 (9.7)26 (14.0)16 (8.6)
    Patient reported doctor had recommended CRC screening91 (49.2)84 (45.4)101 (54.3)97 (51.9)
    Mean barrier scores (SD)1.4 (0.9)1.4 (0.8)1.3 (0.8)1.3 (0.9)
    Subject rated CRC screening highly important (8–10 on scale of 1–10)103 (55.7)105 (56.8)110 (59.1)105 (56.1)
    • ↵* Data are n (%) unless otherwise indicated. There were no significant differences for the variables in this table among the 4 groups.

    • CRC, colorectal cancer; FIT, fecal immunochemical test; SD, standard deviation.

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    Table 2. Medical Record Review Variables*
    VariablesUsual Care (n=177)Physician Chart Reminder (n=173)Mailed Education/FIT (n=178)Mailed Education/FIT + Phone Call (n=176)
    Mean body mass index (SD)31.1 (7.2)31.5 (7.5)30.2 (6.3)30.6 (6.3)
    Visits (26 months before the initial mailing)4 (2, 6)4 (2, 7)4 (2, 7)4 (1, 7)
    Annual visits (26 months before prenotice date)0 (0, 1)0 (0, 1)1 (0, 1)1 (0, 1)
    Medical conditions2 (1, 4)3 (2, 4)3 (2, 4)3 (2, 4)
    Medications (prescription and over the counter)5 (3, 8)5 (2, 7)6 (3, 9)5 (3, 8)
    Any visit during the 15 month follow-up time period, n (%)134 (75.7)133 (76.9)139 (78.1)135 (76.7)
    Any visit in past 26 months, n (%)158 (89.3)150 (86.7)157 (88.2)151 (85.8)
    Annual exam visit in past 26 months, n (%)80 (45.2)83 (48.0)93 (52.3)91 (51.7)
    Cholesterol in past 5 years, n (%)126 (71.2)126 (72.8)128 (71.9)111 (63.1)
    Mammogram in past 26 months, (386 women), n (%)50 (52.1)38 (43.7)51 (54.3)41 (46.1)
    Bone density in past 26 months (88 women ≥65 years old), n (%)5 (19.2)4 (18.2)3 (16.7)5 (22.7)
    PSA level in past 26 months (357 men), n (%)36 (44.4)46 (53.5)34 (40.5)39 (44.8)
    • Values are median (25th percentile, 75th percentile) unless otherwise indicated. There were no significant differences for the variables in this table among the 4 groups.

    • ↵* Only 704 subjects had charts available for review. The total number of available charts was used as the denominator.

    • FIT, fecal immunochemical test; PSA, prostate-specific antigen; SD, standard deviation.

    • View popup
    Table 3. Comparisons of Primary and Secondary Outcomes, with Usual Care as Reference Group
    Tests CompletedUsual Care (n=185)Physician Chart Reminder (n=185)Mailed Education/FIT (n=186)Mailed Education/FIT + Phone Call (n=187)Overall P
    Any CRC test completed during the 15-month follow-up period
        n (%)33 (17.8)38 (20.5)105 (56.5)107 (57.2)<.0001
        OR (95% CI)Reference1.2 (0.7–2.0)6.0 (3.7–9.6)6.2 (3.8–9.9)
    Colonoscopy
        n (%)22 (11.9)33 (17.8)41 (22.0)36 (19.3).073
        OR (95% CI)Reference1.6 (0.9–2.9)2.1 (1.2–3.7)1.8 (1.0–3.1)
    Take home fecal occult blood test (x3), n (%)5 (2.7)5 (2.7)4 (2.2)3 (1.6).875
    Flexible sigmoidoscopy, n (%)1 (0.5)0 (0)0 (0)0 (0).389
    Barium enema, n (%)0 (0)0 (0)0 (0)0 (0)
    FIT returned to investigators, n (%)*——84 (45.2)91 (48.7).498
    • ↵* No fecal immunochemical test (FIT) was mailed to the usual care or chart reminder groups.

    • CI, confidence interval; CRC, colorectal cancer; OR, odds ratio.

    • View popup
    Table 4. Predictors of Becoming Up To Date with Colorectal Cancer (CRC) Screening* Using Prespecified Covariables
    Outcome variable (Any tests completed)Odds Ratio95% CIP
    Intercept——.008
    Chart reminder vs usual care1.230.71–2.11.46
    Mailed education/FIT vs usual care6.293.80–10.43<.0001
    Mailed education/FIT + phone call vs usual care6.383.86–10.54<.0001
    Sex (female vs male)1.060.75–1.49.76
    Education (high school or less vs college)1.000.70–1.42.99
    Insurance (yes vs no)1.260.62–2.58.53
    Age (per 1-year increase)1.010.98–1.03.57
    Family history of CRC (immediate or distant)1.450.95–2.20.08
    Patient reported doctor had recommended CRC screening (yes vs no)1.661.16–2.37.006
    Importance of CRC screening to your health†1.761.23–2.52.002
    Baseline average barrier score‡0.840.67–1.03.10
    Had a physical exam visit during follow-up (yes vs. no)1.481.03–2.11.03
    • ↵* With the SAS Glimmix procedure, which controls for the clustering of patients within practices.

    • ↵† Scores of 8–10 vs 1–7, with higher numbers indicating more importance.

    • ↵‡ Per an increase of 1 in average barrier score, the odds ratio was 0.84 given other variables remain constant in the model. (There were 13 questions about barriers, each of which was scored from 0–5, with higher scores indicating more barriers.)

    • CI, confidence interval; FIT, fecal immunochemical test.

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The Journal of the American Board of Family     Medicine: 26 (5)
The Journal of the American Board of Family Medicine
Vol. 26, Issue 5
September-October 2013
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A Randomized Controlled Trial to Improve Colon Cancer Screening in Rural Family Medicine: An Iowa Research Network (IRENE) Study
Barcey T. Levy, Yinghui Xu, Jeanette M. Daly, John W. Ely
The Journal of the American Board of Family Medicine Sep 2013, 26 (5) 486-497; DOI: 10.3122/jabfm.2013.05.130041

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A Randomized Controlled Trial to Improve Colon Cancer Screening in Rural Family Medicine: An Iowa Research Network (IRENE) Study
Barcey T. Levy, Yinghui Xu, Jeanette M. Daly, John W. Ely
The Journal of the American Board of Family Medicine Sep 2013, 26 (5) 486-497; DOI: 10.3122/jabfm.2013.05.130041
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