ABSTRACT
BACKGROUND
Many individuals at higher risk for cardiovascular disease (CVD) do not receive recommended treatments. Prior interventions using personalized risk information to promote prevention did not test clinic-wide effectiveness.
OBJECTIVE AND DESIGN
To perform a 9-month cluster-randomized trial, comparing a strategy of electronic health record-based identification of patients with increased CVD risk and individualized mailed outreach to usual care.
PARTICIPANTS
Patients of participating physicians with a Framingham Risk Score of at least 5 %, low-density lipoprotein (LDL)-cholesterol level above guideline threshold for drug treatment, and not prescribed a lipid-lowering medication were included in the intention-to-treat analysis.
INTERVENTION
Patients of physicians randomized to the intervention group were mailed individualized CVD risk messages that described benefits of using a statin (and controlling hypertension or quitting smoking when relevant).
MAIN MEASURES
The primary outcome was occurrence of a LDL-cholesterol level, repeated in routine practice, that was at least 30 mg/dl lower than prior. A secondary outcome was lipid-lowering drug prescribing. Clinicaltrials.gov identifier: NCT01286311.
KEY RESULTS
Fourteen physicians with 218 patients were randomized to intervention, and 15 physicians with 217 patients to control. The mean patient age was 60.7 years and 77% were male. There was no difference in the primary outcome (11.0 % vs. 11.1 %, OR 0.99, 95 % CI 0.56–1.74, P = 0.96), but intervention group patients were twice as likely to receive a prescription for lipid-lowering medication (11.9 %, vs. 6.0 %, OR 2.13, 95 % CI 1.05–4.32, p = 0.038). In post hoc analysis with extended follow-up to 18 months, the primary outcome occurred more often in the intervention group (22.5 % vs. 16.1 %, OR 1.59, 95 % CI 1.05–2.41, P = 0.029).
CONCLUSIONS
In this effectiveness trial, individualized mailed CVD risk messages increased the frequency of new lipid-lowering drug prescriptions, but we observed no difference in proportions lowering LDL-cholesterol after 9 months. With longer follow-up, the intervention’s effect on LDL-cholesterol levels was apparent.
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Acknowledgements
Author contribution: Dr. Persell had full access to the study data and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Persell, Lloyd-Jones, Baker
Acquisition of data: Persell, Cooper, Friesema
Analysis and interpretation of data: Persell, Cooper
Drafting of the manuscript: Persell
Critical revision of the manuscript for important intellectual content: Lloyd-Jones, Friesema, Cooper, Baker
Statistical analysis: Persell
Obtained funding: Persell
Study supervision: Persell, Baker
Funding/Support: K08 HS015647, Agency for Healthcare Research and Quality.
Role of the funder: the funding organization had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript.
This work was presented at the Society of General Internal Medicine Annual Meeting in Orlando Florida, May 9, 2012.
Conflict of Interest
The authors declare that they do not have a conflict of interest.
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Grant support: K08 HS015647, Agency for Healthcare Research and Quality Trial registration: Clinicaltrials.gov identifier: NCT01286311.
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Persell, S.D., Lloyd-Jones, D.M., Friesema, E.M. et al. Electronic Health Record-Based Patient Identification and Individualized Mailed Outreach for Primary Cardiovascular Disease Prevention: A Cluster Randomized Trial. J GEN INTERN MED 28, 554–560 (2013). https://doi.org/10.1007/s11606-012-2268-1
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DOI: https://doi.org/10.1007/s11606-012-2268-1