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Research ArticleOriginal Research

Electronic Health Records for Intervention Research: A Cluster Randomized Trial to Reduce Antibiotic Prescribing in Primary Care (eCRT Study)

Martin C. Gulliford, Tjeerd van Staa, Alex Dregan, Lisa McDermott, Gerard McCann, Mark Ashworth, Judith Charlton, Paul Little, Michael V. Moore and Lucy Yardley
The Annals of Family Medicine July 2014, 12 (4) 344-351; DOI: https://doi.org/10.1370/afm.1659
Martin C. Gulliford
1King’s College London, Primary Care and Public Health Sciences, London, United Kingdom
MA, FFPH
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Tjeerd van Staa
2Clinical Practice Research Datalink (CPRD) Division, Medicines and Healthcare Products Regulatory Agency, London, United Kingdom
3London School of Hygiene & Tropical Medicine, London, United Kingdom
PhD
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Alex Dregan
1King’s College London, Primary Care and Public Health Sciences, London, United Kingdom
PhD
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  • For correspondence: alexandru.dregan@kcl.ac.uk
Lisa McDermott
5Division of Community Clinical Sciences, University of Southampton, Southampton, United Kingdom
PhD
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Gerard McCann
2Clinical Practice Research Datalink (CPRD) Division, Medicines and Healthcare Products Regulatory Agency, London, United Kingdom
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Mark Ashworth
1King’s College London, Primary Care and Public Health Sciences, London, United Kingdom
DM
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Judith Charlton
1King’s College London, Primary Care and Public Health Sciences, London, United Kingdom
MSc
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Paul Little
5Division of Community Clinical Sciences, University of Southampton, Southampton, United Kingdom
DM
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Michael V. Moore
5Division of Community Clinical Sciences, University of Southampton, Southampton, United Kingdom
DM
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Lucy Yardley
5Division of Community Clinical Sciences, University of Southampton, Southampton, United Kingdom
PhD
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    Figure 1

    Flow diagram charting progress through the trial.

    CPRD = Clinical Practice Research Datalink; HB =Health Board; PCT = Primary Care Trust; RTI = respiratory tract infection.

    a Figure includes participants contributing to analysis either in 12-month preintervention or 12-month intervention periods.

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    Table 1

    Practice- and Patient-Level Characteristics

    CharacteristicIntervention Trial ArmControl Trial Arm
    Family practices
    Number of family practices5050
    Mean eligible participants aged 18–59 y, No.4,1323,547
    Distribution by region, No. (%)a
     London8 (16)9 (18)
     Midlands9 (18)8 (16)
     North9 (18)8 (16)
     South and East13 (26)13 (26)
     South West8 (16)8 (16)
     Scotland3 (6)4 (8)
    Distribution by start date, No. (%)
     December 201014 (28)17 (34)
     January 201119 (38)17 (34)
     March 201115 (30)15 (30)
     April 20112 (4)1 (2)
    Patients
    Eligible patients aged 18–59 y, No.
     12-Month preintervention period292,398264,137
     12-Month intervention period294,929263,895
    Person years analyzed, No.
     12-Month preintervention period270,437251,994
     12-Month intervention period283,776234,373
    Female patients, No. (%)
     12-Month preintervention period145,116 (50)132,375 (50)
     12-Month intervention period147,199 (50)132,378 (50)
    Patients aged 45–59 y, No. (%)
     12-Month preintervention period102,743 (35)94,194 (36)
     12-Month intervention period102,317 (35)93,850 (36)
    • ↵a Midlands includes East and West Midlands; North includes North East, North West, Yorkshire, and Humberside; South and East includes South Central, South East, and East Anglia.

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    Table 2

    Consultation and Antibiotic Prescribing for Respiratory Tract Infection per 1,000 Registered Patients

    CharacteristicIntervention Trial ArmControl Trial ArmAdjusted Mean Differenced (95% CI)P Value
    Before Mean (Range)After Mean (Range)Before Mean (Range)After Mean (Range)
    RTI consultation ratea219 (181–254)209 (176–247)216 (186–246)218 (184–244)−9.10 (−21.51 to 3.30).148
    Antibiotic prescription rateb116 (91–131)108 (87–129)111 (86–135)114 (85–128)−9.69 (−18.63 to −0.75).034
    Antibiotic prescriptions per RTI consultationc53 (46–60)52 (45–58)52 (45–60)52 (45–59)−1.85 (−3.59 to −0.10).038
    • RTI=respiratory tract infection.

    • Note: Figures are mean (interquartile range) of family practice-specific values for 12 months before and after intervention.

    • ↵a Consultation rate per 1,000 person-years.

    • ↵b Antibiotic prescriptions for respiratory tract infections per 1,000 person-years.

    • ↵c Proportion of consultations with antibiotic prescribed.

    • ↵d Difference between intervention and control trial arms after intervention, adjusting for preintervention value, as well as mean age and proportion of women at each practice.

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    Table 3

    Proportion of Consultations for Different Types of Respiratory Tract Infection With Antibiotic Prescribed

    Infection TypeIntervention Trial ArmControl Trial ArmAdjusted Mean Differencea (95% CI)P Value
    Before Mean (Range)After Mean (Range)Before Mean (Range)After Mean (Range)
    Cough and bronchitis47 (36–59)45 (37–52)46 (38–55)47 (38–55)−2.49 (−4.83 to −0.15).030
    Colds37 (21–48)36 (22–46)38 (27–50)38 (30–49)−1.05 (−4.28 to 2.18).519
    Otitis media59 (45–73)56 (43–67)60 (48–72)57 (47–71)−1.54 (−6.85 to 3.77).566
    Rhinosinusitis89 (82–95)89 (83–92)88 (86–94)86 (82–93)1.07 (−1.26 to 3.41).362
    Sore throat58 (51–65)57 (50–64)57 (50–67)57 (48–66)−1.59 (−4.27 to 1.09).242
    • Note: Figures are mean (interquartile range) of family practice-specific values for 12 months before and after the intervention, except where indicated.

    • ↵a Difference between intervention and control trial arms after intervention, adjusting for preintervention value, as well as mean age and proportion of women at each practice.

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    Table 4

    Intervention Utilization and Antibiotic Prescribing by Quartile of Intervention Utilization

    Control PracticesLowest Quartile of Utilization (13)aSecond Quartile (13)Third Quartile (13)Highest Quartile of Utilization (13)
    Intervention utilization (per 1,000 consultations for RTI)
     Prompt views, median (IQR)Not applicable0 (0–0)12 (7–18)63 (46–68)159 (104–166)
     Leaflets printed, median (IQR)Not applicable0 (0–0)6 (0–0)3 (2–4)25 (13–40)
    RTI consultations with antibiotics prescribed, % (IQR)
     Before intervention52 (45–59)55 (49–61)53 (46–59)55 (51–63)50 (41–57)
     After intervention52 (45–59)54 (46–63)54 (51–60)53 (52–61)48 (42–54)
     Unadjusted mean difference, No. (95% Cl)0.7 (−0.6 to 2.0)−1.2 (−5.1 to 2.8)−1.0 (−2.9 to 0.9)−1.4 (−3.9 to 1.0)−1.6 (−5.0 to 1.7)
    Adjusted test for trend across categories, No. (95% CI)b−0.64 (−1.23 to −0.05),c P =.034
    • IQR=interquartile range; RTI =respiratory tract infection.

    • ↵a Figures refer to number (range?) of intervention practices.

    • ↵b Adjusted for mean age and proportion of women.

    • ↵c Coefficient represents the decrement in antibiotic utilization per quartile increase in intervention utilization.

Additional Files

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  • In Brief

    Electronic Health Records for Intervention Research: A Cluster Randomized Trial to Reduce Antibiotic Prescribing in Primary Care (eCRT Study)

    Alex Dregan , and colleagues

    Background Because implementing cluster randomized trials can be logistically challenging, costly and time-consuming, researchers sought to evaluate the feasibility of conducting intervention research remotely using primary care electronic health records. Specifically, the authors looked at the effectiveness of electronically delivered decision support tools at reducing antibiotic prescribing for respiratory tract infections in a randomized trial of 603,409 primary care patients in England and Scotland.

    What This Study Found Intervention arm practices used decision support tools remotely installed and delivered during consultations that were activated when family physicians entered a medical code for the respiratory tract infection. The tools provided information for education and decision support, including a summary of antibiotic prescribing recommendations, a patient-information sheet, summary of research evidence concerning no-antibiotic or delayed-antibiotic prescribing strategies, information on the definite indications for antibiotic prescription and information and evidence on the risks from nonprescribing. The researchers found the use of the intervention and its effect on care were low ? one-quarter of intervention family practices made little or no use of the intervention, and antibiotic prescribing was only slightly lower at practices that made greater use of the intervention (a 1.85% reduction in the proportion of consultations with antibiotics prescribed). Despite the limited impact, however, the study demonstrates that cluster randomized trials can be conducted remotely through electronic health records.

    Implications

    • Using electronic health records in intervention research, the authors assert, has the potential to allow large studies to be conducted at a low cost in settings where care is routinely delivered, making it suitable for the evaluation of important clinical and public health interventions.
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The Annals of Family Medicine: 12 (4)
The Annals of Family Medicine: 12 (4)
Vol. 12, Issue 4
July/August 2014
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Electronic Health Records for Intervention Research: A Cluster Randomized Trial to Reduce Antibiotic Prescribing in Primary Care (eCRT Study)
Martin C. Gulliford, Tjeerd van Staa, Alex Dregan, Lisa McDermott, Gerard McCann, Mark Ashworth, Judith Charlton, Paul Little, Michael V. Moore, Lucy Yardley
The Annals of Family Medicine Jul 2014, 12 (4) 344-351; DOI: 10.1370/afm.1659

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Electronic Health Records for Intervention Research: A Cluster Randomized Trial to Reduce Antibiotic Prescribing in Primary Care (eCRT Study)
Martin C. Gulliford, Tjeerd van Staa, Alex Dregan, Lisa McDermott, Gerard McCann, Mark Ashworth, Judith Charlton, Paul Little, Michael V. Moore, Lucy Yardley
The Annals of Family Medicine Jul 2014, 12 (4) 344-351; DOI: 10.1370/afm.1659
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