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Research ArticleOriginal Research

Absolute Cardiovascular Disease Risk and Shared Decision Making in Primary Care: A Randomized Controlled Trial

Tanja Krones, Heidemarie Keller, Andreas Sönnichsen, Eva-Maria Sadowski, Erika Baum, Karl Wegscheider, Justine Rochon and Norbert Donner-Banzhoff
The Annals of Family Medicine May 2008, 6 (3) 218-227; DOI: https://doi.org/10.1370/afm.854
Tanja Krones
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Heidemarie Keller
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Andreas Sönnichsen
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Eva-Maria Sadowski
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Erika Baum
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Karl Wegscheider
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Justine Rochon
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Norbert Donner-Banzhoff
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    Figure 1.

    Study flowchart—CME groups, practices, and patients.

    CME = continuing medical education.

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    Table 1.

    Decision Aid Steps: ARRIBA-Herz – The Script

    StepComponents
    1. Agree on taskCalculate individual absolute risk for stroke and/or myocardial infarction, involving patient in decision making
    2. Explore subjective riskAddress fears, expectations, preferences, questions of patients
    3. Calculate and show objective riskAssess individual risk factors (eg, age, blood pressure, total cholesterol), calculate risk, compare with population with identical sex and age, provide probabilities in absolute numbers
    4. Present preventive optionsInclude behavioral change and medication
    5. Discuss pros and consInclude nonaction
    6. Agree on course of actionInclude date of next consultation
    • View popup
    Table 2.

    Baseline Characteristics of Participating Family Doctors by Intervention (n = 44) and Control Group (n = 47)

    Baseline VariablesIntervention Group No. (%)Control Group No. (%)χ2P Value
    GP age, years3.8.279
        31–402 (4.5)1 (2.1)
        41–5024 (54.5)24 (51.1)
        51–6017 (38.6)16 (34.0)
        >601 (2.3)6 (12.8)
    Male27 (61.4)26 (55.3)3.4.671
    Geographical location (% urban)20 (45.5)20 (42.6)0.07.837
    Practice size (practice attendance per 3-month period)11.4.01
        <5001 (2.3)3 (6.4)
        500–1,0006 (13.6)19 (40.4)
        1,000–1,50021 (47.7)18 (38.3)
        >1,50016 (36.4)7 (14.9)
    • View popup
    Table 3.

    Baseline Characteristics of Patients by Intervention and Control Group.

    VariableIntervention Group (n=550)Control Group (n=582)χ2 (df)P Value
    a Mean cardiovascular risk in % for 10 years at baseline, calculated by Framingham risk points, is displayed for patients in primary prevention only, including patients with diabetes.
    Mean age, years (SD)59.1 (12.3)58.6 (12.5)0.69.49
    Male, No. (%)231 (42.0)265 (45.5)1.4 (1).26
    Nationality German, No. (%)528 (96.0)566 (97.3)0.83 (1).46
    Education, No. (%)2.1 (4).71
        No or basic education284 (51.6)320 (54.9)
        Medium education169 (30.7)168 (28.9)
        Higher education91 (16.6)91 (15.6)
    Smokers, No. (%)102 (18.5)108 (18.6)0.0 (1)1.0
    Diabetic, No. (%)63 (11.5)140 (24.1)30.1 (1)<.001
    Previous cardiovascular disease, No. (%)101 (18.4)130 (22.3)2.7 (1).10
    Mean cardiovascular risk at baselinea (SD)10.7 (9.5)10.1 (9.2)098 (899).33
    Subjective health status, No. (%)5.2 (4).27
        Very good/good266 (48.4)260 (44.7)
        Satisfactory242 (44.0)278 (47.8)
        Very bad/bad36 (6.5)40 (6.9)
    Preference of participation in decision, No. (%)13.4 (4).009
        Patient only6 (1.1)11 (1.9)
        Patient mainly14 (2.5)16 (2.7)
        Patient and doctor405 (73.6)383 (65.8)
        Doctor mainly99 (18.0)114 (19.6)
        Doctor only15 (2.7)39 (6.7)
    • View popup
    Table 4.

    Outcome Variables by Intervention, All Clusters (14 CME Groups) Contributing to Every Analysis

    VariableIntervention GroupaControl GroupaEstimated ICC of CME Group/PracticeDifference Intervention – Control (95% CI)Adjusted F StatisticP Valuea
    CME = continuing medical education; CVD = cardiovascular disease; ICC = intraclass correlation; SDM = shared decision making.
    a Values are adjusted estimated means, numbers of patients (n) and P values in mixed models adjusted for confounders (see Methods) and cluster structure (CME group, practice nested within CME group, patients nested within practice).
    b Lower scores denoting higher participation and satisfaction.
    c Mean change of CVD risk (%) was calculated by Framingham risk points for all patients, including patients with diabetes and secondary prevention (focus on relative change).
    Evaluation after index consultation
    Patient participation and satisfactionb6.76 (501)7.56 (536)0.00/0.06−0.80 (−1.23 to −0.37)13.55<.001
    SDM steps reported9.48 (407)7.49 (442)0.00/0.071.99 (1.27 to 2.71)30.21<.001
    Knowledge2.03 (535)1.92 (576)0.001/0.060.11 (−0.01 to 0.24)3.36.07
    Follow-up examination
    Mean change of CVD riskc−3.00 (415)−3.33 (407)0.006/0.020.32 (−0.30 to 0.95)1.07.31
    Decisional regret14.69 (372)18.08 (372)0.00 /0.02−3.39 (−6.26 to −0.53)6.58.02
    • View popup
    Table 5.

    Steps of Shared Decision-Making Process During Consultation as Reported by Patients Directly After Consultation

    Steps and StatementsIntervention Group % Agree (n)Control Group % Agree (n)P ValueaEstimated ICC of CME Group/Practicea
    a After adjustment for confounders, see also methods section.
    b Because item expresses the opposite, high percentages representing less involvement of patients, it has been inverted before summing up shared decision making steps in Table 4.
    Step 1. Disclosure, that a decision needs to be made
    My doctor told me that a treatment decision is necessary42.9 (236/550)39.0 (227/582).1600.035/0.125
    Step 2. Formulation of equality of partners
    My doctor asked me, if I want to participate in decision making64.2 (353/550)46.1 (268/582)<.0010.000/0.083
    Step 3. Equipoise statementb
    Due to my medical condition, treatment decision based on physicians’ recommendation is already clear53.8 (296/550)58.4 (340/582).8670.000/0.000
    Step 4. Informing on the options’ benefits and risks
    My doctor has informed me about a variety of alternatives64.0 (352/550)47.9 (279/582)<.0010.000/0.203
    The possibility to choose no treatment was also discussed55.3 (304/550)36.9 (215/582)<.0010.000/0.076
    Step 5. Investigation of patient’s understanding and expectations
    I have mentioned other possibilities that my doctor has not referred to14.4 (79/550)8.9 (52/582).0750.000/0.089
    My doctor has asked me how I think about different treatment options62.9 (346/550)37.6 (219/582)<.0010.000/0.281
    Step 6. Identification of preferences (both)
    I have communicated to my doctor which decision I do prefer55.5 (305/550)34.7 (202/582)<.0010.000/0.145
    My doctor has told me which decision he prefers68.9 (379/550)57.6 (335/582)<.0010.000/0.153
    Step 7. Negotiation
    In the selection of treatment method, my thoughts were taken into account just as much as the considerations of my doctor77.1 (424/550)61.3 (357/582)<.0010.001/0. 184
    My doctor and I weighted up the different treatment options thoroughly67.6 (372/550)51.2 (298/582)<.0010.000/0. 113
    Step 8. Shared decision making
    My doctor enabled me to actively participate in decision making about treatment79.1 (435/550)64.3 (374/582)<.0010.000/0.118
    My doctor and I selected a treatment together65.8 (362/550)55.8 (325/582).0040.000/0.149
    Step 9. Arrangement of follow-up
    My doctor and I reached an agreement as to how we will proceed78.9 (434/550)70.4 (410/582).0060.013/0. 196

Additional Files

  • Figures
  • Tables
  • Supplemental Appendix

    Supplemental Appendix. ARRIBA-Herz Decision Aid

    Files in this Data Supplement:

    • Supplemental data: Appendix - PDF file, 3 pages, 455 KB
  • The Article in Brief

    What This Study Found Patients who use the decision aid are more involved in decision making, more satisfied, and have less regret about their health care decisions.

    Implications

    • This decision aid helps doctors and patients discuss individual concerns and pace information according to patients� needs.
    • Decision aids completed by patients on their own, as well as those used during a visit to the doctor, are important, might be combined, and deserve further study.
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The Annals of Family Medicine: 6 (3)
The Annals of Family Medicine
Vol. 6, Issue 3
1 May 2008
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Absolute Cardiovascular Disease Risk and Shared Decision Making in Primary Care: A Randomized Controlled Trial
Tanja Krones, Heidemarie Keller, Andreas Sönnichsen, Eva-Maria Sadowski, Erika Baum, Karl Wegscheider, Justine Rochon, Norbert Donner-Banzhoff
The Annals of Family Medicine May 2008, 6 (3) 218-227; DOI: 10.1370/afm.854

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Absolute Cardiovascular Disease Risk and Shared Decision Making in Primary Care: A Randomized Controlled Trial
Tanja Krones, Heidemarie Keller, Andreas Sönnichsen, Eva-Maria Sadowski, Erika Baum, Karl Wegscheider, Justine Rochon, Norbert Donner-Banzhoff
The Annals of Family Medicine May 2008, 6 (3) 218-227; DOI: 10.1370/afm.854
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