Fixed Dose Intervention Trial of New England Enhancing Survival in SMI Patients
Status:
Unknown status
Trial end date:
2021-10-01
Target enrollment:
Participant gender:
Summary
Patients with severe mental illness (SMI) die younger than persons in the general population.
Much of the excess mortality for SMI patients is attributable to cardiovascular disease, and
is exacerbated by treatment with second-generation antipsychotics (2GAs). Although the
cardiovascular risks are well-known, and safe, efficacious therapy exists, few SMI patients
receive cardiovascular prevention drugs. Care delivery fragmentation and poor patient
adherence are central problems to reducing cardiovascular risks for patients with SMI. To
address these problems, we propose to conduct a multi-site, open-label, randomized controlled
trial comparing an initial treatment strategy of free, fixed-doses of two generic,
cardiovascular prevention drugs (statins and angiotensin drugs) delivered within mental
health clinics versus usual treatment. The study will include adult patients (18+ years old)
with schizophrenia, schizoaffective disorder, bipolar disorder, major depressive disorder, or
psychosis not otherwise specified (NOS) who have received 2GAs treatment within the past six
months from within four mental health clinics in the Boston area. We have three aims: 1) to
compare the proportions of subjects in each arm who are receiving cardiovascular drug
treatment and are adherent to therapy during 12-months of follow-up; 2) to compare changes in
composite (e.g., Framingham scores) and individual (e.g., lipid levels) cardiovascular risk
factor levels using an intent-to-treat (ITT) approach; and 3) to compare risk factor levels,
accounting for variation in adherence over time, using causal inference techniques to
estimate the per-protocol effect of the intervention. Our three aims examine whether this low
cost, streamlined treatment strategy increases the numbers of subjects receiving
cardiovascular prevention therapy and improves cardiovascular risk levels. We will follow
subjects for 12 months, and collect interview and biometric data at baseline and over the
following 12 months. Subjects will have the option to continue for another 12 months, during
which we will continue to collect interview and biometric data, but will not prescribe
cardiovascular medications. This population-based initial treatment strategy could be an
effective and efficient approach for overcoming traditional barriers to cardiovascular
disease prevention within the SMI population. Findings from this study will inform efforts to
improve care and outcomes, and to enhance survival for patients with severe mental illness.
Phase:
Phase 4
Details
Lead Sponsor:
Mclean Hospital
Collaborators:
Dauten Family Center for Bipolar Treatment Innovation at Massachusetts General Hospital Michael J. Gill Mental Health Clinic The Edinburg Center, Bedford MA The Massachusetts Mental Health Center