Available online 26 April 2024

Author links open overlay panel, , , , , , , , , , , , , ABSTRACTBackground

In patients with or at risk for atherosclerotic vascular disease, statins reduce the incidence of major adverse cardiovascular events, but the majority of U.S. adults with an indication for statin therapy are not prescribed statins at guideline-recommended intensity. Clinicians’ limited time to address preventative care issues is cited as one factor contributing to gaps in statin prescribing. Centralized pharmacy services can fulfill a strategic role for population health management through outreach, education, and statin prescribing for patients at elevated ASCVD risk, but best practices for optimizing referrals of appropriate patients are unknown.

Study Design and Objectives

SUPER LIPID (NCT05537064) is a program consisting of two pragmatic clinical trials testing the effect of nudges in increasing referrals of appropriate patients to a centralized pharmacy service for lipid management, conducted within 11 primary care practices in a large community health system. In both trials, patients were eligible for inclusion if they had an assigned primary care provider (PCP) in a participating practice and were not prescribed a high- or moderate-intensity statin despite an indication, identified via an electronic health record (EHR) algorithm. Trial #1 was a stepped wedge trial, conducted at a single practice with randomization at the PCP level, of an interruptive EHR message that appeared during eligible patients’ visits and facilitated referral to the pharmacy service. For the first 3 months, no PCPs received the message; for the second 3 months, half were randomly selected to receive the message; and for the last 3 months, all PCPs received the message. Trial #2 was a cluster-randomized trial conducted at 10 practices, with randomization at the practice level. Practices were randomized to usual care or to have eligible patients automatically referred to centralized pharmacy services via a referral order placed in PCPs EHR inboxes for co-signature. In both trials, when a patient was referred to centralized pharmacy services, a pharmacist reviewed the patient's chart, contacted the patient, and initiated statin therapy if the patient agreed. The primary endpoint of both trials was the proportion of patients prescribed a statin; secondary endpoints include the proportion of patients prescribed a statin at guideline-recommended intensity, the proportion of patients filling a statin prescription, and serum low-density lipoprotein level.

Conclusions

SUPER LIPID is a pair of pragmatic clinical trials assessing the effectiveness of two strategies to encourage referral of appropriate patients to a centralized pharmacy service for lipid management. The trial results will develop the evidence base for simple, scalable, EHR-based strategies to integrate clinical pharmacists into population health management and increase appropriate statin prescribing.

Clinical trial registration

clinicaltrials.gov; NCT05537064

Section snippetsMETHODS

SUPER LIPID is funded by a Clinical and Translational Science Award (Fitzgerald PI, Volpp Co-PI) from the National Center for Advancing Translational Science to the University of Pennsylvania and with institutional support from Penn Medicine. It is registered at clinicaltrials.gov (NCT05537064). The study protocol was approved by the University of Pennsylvania and Lancaster General Health System (LGH) Institutional Review Boards. The authors are solely responsible for the design and conduct of

STATISTICAL CONSIDERATIONS

All analyses will be conducted using the intention-to-treat principle, meaning that eligible patients (those with an indication for high- or moderate-intensity statin but not prescribed a high-intensity statin) will be identified prior to the initiation of any intervention and will be evaluated in the group to which they are randomized, even if they become ineligible for the study prior to delivery of the intervention. This could occur if, for example, they are prescribed a statin, change

TRIAL STATUS

Trial #1 began in August 2022, with the BPA becoming active in the EHR for the first group in November 2022 and the second group in February 2023. Trial #2 began in November 2022. Both trials completed enrollment in May 2023. Ultimately, 1412 patients were enrolled in Trial #1 (the stepped wedge trial of an interruptive pop-up EHR notification), and had 2504 encounters over the course of the study, with the interruptive pop-up EHR notification appearing during 1163 unique encounters (46.4% of

CONCLUSIONS

SUPER LIPID is a pair of pragmatic clinical trials, conducted within 11 primary care practices in a single community health care system, assessing the effectiveness of two strategies to encourage referral of appropriate patients to a centralized pharmacy service for lipid management. The trial results will develop the evidence base for simple, scalable, EHR-based strategies to integrate clinical pharmacists into population health management, and if either intervention is effective, it could be

CRediT authorship contribution statement

Alexander C. Fanaroff: . Qian Huang: Writing – review & editing, Visualization, Investigation, Formal analysis, Data curation. Kayla Clark: Writing – review & editing, Supervision, Resources, Project administration, Investigation, Data curation. Laurie A. Norton: Writing – review & editing, Supervision, Project administration, Investigation, Data curation. Wendell E. Kellum: Writing – review & editing, Supervision, Resources, Project administration, Investigation, Conceptualization. Dwight

CONFLICTS OF INTEREST

Dr. Fanaroff reports a career development grant from the American Heart Association. Dr. Adusumalli is an employee of CVS Health. Dr. Volpp is a co-owner of a behavioral economics consulting firm, VAL Health and receives unrelated research funding from Independence Blue Cross and the American Heart Association. All other authors report no relevant conflicts of interest.

FUNDING

SUPER LIPID was was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health under award number UL1TR001878 (Fitzgerald PI, Volpp Co-PI), and with institutional support funding from Penn Medicine. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Subject terms

population health management, statins, cardiovascular diseases, behavioral economics

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