Two randomized controlled trials of nudges to encourage referrals to centralized pharmacy services for evidence-based statin initiation in high-risk patients: Rationale and design of the SUPER LIPID program.

BACKGROUND: In patients with or at risk for atherosclerotic vascular disease, statins reduce the incidence of major adverse cardiovascular events, but the majority of US 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.

Engaging Stakeholders to Improve Care for Adults with Complex Health and Social Needs during a Public Health Emergency.

A public health emergency such as the COVID-19 pandemic exacerbates the already challenging environment facing adults with complex health and social needs (ACHSN) and the systems of care that support them. Between September 2020 and April 2021, 51 participants representing six different stakeholder groups were engaged using interviews, asynchronous Delphi surveys, and a virtual stakeholder meeting to learn from their perspectives about the greatest needs and possible solutions affecting ACHSN populations during the COVID-19 pandemic and to develop a prioritized research agenda to improve care for ACHSN populations. Mental health and financial concerns were strongly and consistently endorsed as the most important issues. Future research priorities identified included both macro systems research such as testing alternative state-level models of payment for physical and mental health care and research that could be conducted at a local level (such as identifying needs for patient care navigation services and testing models of care navigation).

Developing a Research Agenda for Adults with Complex Health and Social Needs.

This work presents a research agenda addressing the needs of adults with complex health and social needs (ACHSN) formulated through an engagement process fostering cross-stakeholder group communication, shared understanding of identified issues, and mutual commitment to improving care for ACHSN. Nominal group technique and stakeholder interviews were used to develop prioritized stakeholder consensus regarding health issues, barriers, and solutions affecting ACHSN. The engagement process culminated in two stakeholder meetings with all stakeholders to review, process, and develop a shared understanding of the findings. Issues prioritized for future research included the conditions of mental health, diabetes, and addiction; and interventions addressing the barriers of comorbidities, support for mental health, and cost of care/logistics. Notable areas of alignment and variance existed across stakeholder perspectives. Emphasized themes especially relevant to future research included the importance of grounding interventions in multi-stakeholder shared understanding and active inclusion of the patient voice.