Research ArticleOriginal Research

A Cluster Randomized Trial Comparing Strategies for Translating Self-Management Support into Primary Care Practices

W. Perry Dickinson, L. Miriam Dickinson, Bonnie T. Jortberg, Danielle M. Hessler, Douglas H. Fernald, Michael Cuffney and Lawrence Fisher
The Journal of the American Board of Family Medicine May 2019, 32 (3) 341-352; DOI: https://doi.org/10.3122/jabfm.2019.03.180254

Article Figures & Data

Figures

  • Figure 1.
    Figure 1.

    Connection to health project CONSORT diagram. CTH, Connection to Health; CTH+PF; Connection to Health with practice facilitation; SMS, self-management support; SMS-ED, self-management support education.

Tables

  • Table 1.

    Approaches to Implementing Self-Management Support for Type 2 Diabetes—Program Elements across Project Arms (2012–2018)

    Program ElementSMS-EDCTHCTH + F
    CTH computerized intervention programNoYesYes
    Technical assistance with CTH implementationNoYesYes
    Basic instructions on use of CTHNoYesYes
    Assessment of baseline SMS and diabetes care activitiesYesYesYes
    Feedback of assessment and recommendations for practiceNoNoYes
    SMS education sessions with practiceYesYesYes
    Website with SMS resourcesYesYesYes
    Practice facilitation:NoNoYes
        Improvement team meetings: 4 over approximately 3 months.
        Workflow revision to implement CTH
        Email contacts, other assistance between improvement team meetings and after 3 months as needed
        Ongoing feedback of data regarding CTH usage

    • CTH, Connection to Health; CTH + PF, Connection to Health with Practice Facilitation; SMS, self-management support; SMS-ED, self-management support education.

  • Table 2.

    Baseline Practice and Patient Characteristics

    Practice CharacteristicsSMS-EDCTHCTH + PF
    N111213
    Practice Type Federally Qualified Health Center, n (%)9 (81.8%)9 (75%)9 (69.2%)
    Number of clinicians, mean (SD)7.4 (3.4)7.3 (4.1)6.1 (4.3)
    % Medicaid, mean (SD)41.5 (21.5)35.1 (22.0)38.7 (18.4)
    % Uninsured, mean (SD)27.3 (17.928.2 (19.1)25.6 (21.2)
    % HbA1c > 9, mean (SD)28.4 (11.1)22.9 (9.1)28.5 (5.6)
    Number of diabetic patients, mean (SD)589.8 (392.4541.3 (385.2)408.9 (309.0)
    PCMH Status:
        Some implementation, but not recognition, n (%)1 (9.1%)3 (25.0%)4 (30.8%)
        PCMH recognition, n (%)8 (72.7%)8 (66.7%)8 (61.5%)

    • CTH, Connection to Health; CTH + PF, Connection to Health with Practice Facilitation; HbA1c, Hemoglobin A1c; PCMH, patient centered medical home; SMS, self-management support; SMS-ED, self-management support education; SD, standard deviation.

  • Table 3.

    Patient Characteristics (From Chart Audits)

    VariableSMS-ED Arm: Intent to Treat and Per Protocol Samples, Mean (SD) or %CTH Arm: ITT Sample, Mean (SD) or %CTH Arm: CTH Per Protocol, Mean (SD) or %CTH + PF Arm: ITT Sample, Mean (SD) or %CTH + PF Arm: CTH Per Protocol Sample, Mean (SD) or %
    N31236040385127
    Gender, % female54.5%60.6%62.5%57.4%60.6%
    Age (years)58.3 (12.8)60.0 (12.6)58.3 (12.5)60.8 (11.5)58.3 (11.6)
    Number of medical co-morbidities1.8 (1.1)1.7 (1.0)1.4 (0.9)1.8 (1.0)1.9 (1.0)
    Comorbid conditions
        Hypertension73.4%66.1%65.0%70.1%72.4%
        Pulmonary13.1%10.8%7.5%15.3%15.8%
        Diabetic nephropathy11.5%12.8%5.0%10.7%10.2%
        Renal disease10.9%8.1%5.0%3.6%11.8%
        Cardiovascular disease7.4%6.9%0.0%10.9%11.8%
        Depression18.9%20.0%17.5%19.2%23.6%
    Current smoker19.6%14.4%10.0%15.1%13.4%
    Baseline HbA1c8.1 (2.2)7.9 (2.0)7.9 (2.0)7.8 (1.9)8.5 (1.9)
    Baseline body mass index32.6 (7.6)32.1 (7.3)32.4 (5.3)33.3 (7.2)34.7 (7.9)
    Baseline systolic BP129.7 (16.1)130.9 (16.9)130.9 (17.6)128.7 (13.5)129.6 (16.4)
    Baseline diastolic BP76.6 (9.0)77.6 (9.3)78.2 (7.8)76.6 (8.5)78.9 (9.7)
    Medications
        Lipid lowering med61.4%65.2%77.5%68.5%71.7%
        Antihypertensive75.2%74.4%77.5%78.9%78.0%
        Antidepressant21.6%34.1%22.5%36.5%22.8%
        Oral diabetic med74.3%81.1%85.0%81.3%72.2%
        Insulin34.3%33.6%25.0%28.6%41.7%

    • BP, blood pressure; CTH, Connection to Health; CTH + PF; Connection to Health with practice facilitation; HbA1c, hemoglobin A1c; ITT, intent to treat; PF, practice facilitation; SMS-ED, self-management support education; SD, standard deviation.

  • Table 4.

    Intent to Treat and Connection to Health Per Protocol Comparisons of Impact on Hemoglobin A1c over Time

    Outcome Is HbA1c Over TimeIntent to Treat, N = 1022Connection to Health Per Protocol, N = 458
    VariableAdjusted Models, Coef (SE)P-ValueAdjusted Models, Coef (SE)P-Value
    Intercept7.5385 (0.1941)<.00016.6848 (0.2368)<.0001
    Age group (years)
        17 to 49Ref—Ref—
        50 to 640.8017 (0.1368)<.00010.8571 (0.1956)<.0001
        65 or greater−1.2746 (0.1449)<.0001−1.057 (0.2199)<.0001
    Female gender0.0881 (0.1034).39420.2259 (0.1572).1509
    BMI (at baseline, centered)−0.0232 (0.0070).0010−0.0436 (0.0105)<.0001
    Pulmonary−0.4775 (0.2289).0371
    Diabetic retinopathy0.3368 (0.1595).0348
    Renal0.4531 (0.2587).0801
    Oral diabetic medications0.7150 (0.1287)<.00010.6452 (0.1817).0004
    Insulin1.7418 (0.1117)<.00011.7147 (0.1663)<.0001
    Intervention vs SMS-ED (at baseline)
        CTH vs SMS-ED−0.0987 (0.1551).5245−0.049 (0.3530).8891
        CTH + PF vs SMS-ED0.0160 (0.1524).91640.6519 (0.2300).0047
    HbA1c change per 12 months (slope)Compared to SMS−EDCompared to SMS−ED
    SMS-ED0.1638 (0.0853)—0.1546 (0.0920)—
    CTH0.3022 (0.0756).22430.0671 (0.2255).7193
    CTH + PF0.1441 (0.0721).8601−0.1640 (0.1269).0422

    • BMI, body mass index; CTH, Connection to Health; CTH + PF, Connection to Health with practice facilitation; HbA1c, hemoglobin A1c; SMS-ED, self-management support education; SE, standard error.

    • Overall P-value for group x time: 0.2724. The overall group x time effect is used to determine whether there are differences in slopes between the three study arms. The coefficients in the table show the actual slopes (SE) for each study arm, along with the p-value for the differences for CTH vs SMS-ED, and CTH + PF vs SMS-ED.

  • Table 5.

    Intent to Treat and Connection to Health Per Protocol Comparisons of Self Management Support Activities over Time

    Outcome Is Hemoglobin A1c Over TimeIntent To Treat N = 1054CTH Per Protocol N = 479
    VariableAdjusted Models, Coef (SE)P-ValueAdjusted models, Coef (SE)P-Value
    Intercept3.94 (1.32)—3.04 (2.87)—
    Age group (years)
        17 to 49ref—Ref—
        50 to 640.47 (0.61).44630.98 (0.94).2984
        65 or greater−1.34 (0.66).0412−1.16 (1.04).2673
    Female gender. 0.39 (0.46).40081.53 (0.73).0376
    Depression3.28 (0.58)<.0001
    Insulin3.39 (0.50)<.00015.03 (0.80)<.0001
    Intervention vs SMS-ED (at baseline)
        CTH vs SMS-ED−0.27 (1.67).87051.81 (4.73).7026
        CTH + PF vs SMS-ED0.81 (1.63).62214.87 (3.96).2192
    Pre-post changeCompared to SMS−EDCompared to SMS−ED
        SMS-ED4.58 (0.72)—4.56 (0.84)—
        CTH6.82 (0.66).022315.63 (2.32)<.0001
        CTH + PF7.68 (0.64).001314.94 (1.30)<.0001

    • CTH, Connection to Health, CTH + PF = Connection to Health with practice facilitation; SMS-ED, self-management support education,.

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