Fixed Dose Intervention Trial of New England Enhancing Survival in SMI Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Depression, Depression, Peripheral Vascular Disease, Schizophrenia, Major Depression Disorder (MDD), Psychiatric, Psychiatric, Psychiatric, Bipolar Disorder |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 89 |
| Updated: | 8/23/2018 |
| Start Date: | February 2015 |
| End Date: | December 2020 |
| Contact: | Dost Ongur, MD PhD |
| Email: | DONGUR@PARTNERS.ORG |
| Phone: | 6178553922 |
Fixed Dose Intervention Trial of New England Enhancing Survival in Serious Mental Illness Patients
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.
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.
By design, all subjects in the Intervention arm will start by being under treatment. During
the course of follow-up, we expect that some will stay consistently on treatment, some will
discontinue treatment (become non-adherent), while others will make transitions on and off
treatment in various patterns. In contrast, by design, subjects in the Usual Treatment
(control) arm do not start on treatment; however, some will initiate treatment as a result of
usual clinical care, e.g., primary care physician initiation. At any point we will be
comparing two binary outcomes (on or off treatment) and will use standard methods for
comparing two proportions to test statistical significance and get confidence intervals for
the difference in the percent on treatment in the two arms. Participants who are ineligible
for randomization will be followed similarly to participants in the Usual Treatment Arm, in a
third, non-randomized group, which will be excluded from the primary analysis.
the course of follow-up, we expect that some will stay consistently on treatment, some will
discontinue treatment (become non-adherent), while others will make transitions on and off
treatment in various patterns. In contrast, by design, subjects in the Usual Treatment
(control) arm do not start on treatment; however, some will initiate treatment as a result of
usual clinical care, e.g., primary care physician initiation. At any point we will be
comparing two binary outcomes (on or off treatment) and will use standard methods for
comparing two proportions to test statistical significance and get confidence intervals for
the difference in the percent on treatment in the two arms. Participants who are ineligible
for randomization will be followed similarly to participants in the Usual Treatment Arm, in a
third, non-randomized group, which will be excluded from the primary analysis.
Inclusion Criteria:
- Incident or prevalent cases: schizophrenia, schizoaffective disorder, bipolar
disorder, major depressive disorder, or psychosis NOS (chart diagnosis).
- Age 18 years and older.
- Recent treatment with a standing 2GA, e.g., receiving a standing 2GA in the past 6
months.
- Concomitant psychotropic medications will be allowed.
- Ongoing treatment of their mental illnesses at one of four study mental health
clinics, defined as entering one of the two-year First Episode Clinic treatment
programs as a de novo patient (new disease) or having been diagnosed >2 years ago and
had at least six visits in the past 12 months (prevalent disease).
Exclusion Criteria:
- • Unstable/active disease or potential contraindications with both study medications,
e.g., diabetes, unstable angina or recent acute coronary syndrome, pregnancy, very
high risk factors on the screening labs (e.g., A1c>7%), renal failure, liver failure,
or both statin and angiotension drug contraindications.
- Unable to provide informed consent, e.g., has dementia, developmental disability,
other cognitive disorder, or fails screening mini-mental status exam (subjects
with guardians may participate with guardian consent)
- Receiving active cardiovascular treatment, defined as receiving both a statin or
ARB in the past three months.
We found this trial at
1
site
115 Mill St
Belmont, Massachusetts 02478
Belmont, Massachusetts 02478
(617) 855-2000
Principal Investigator: Dost Ongur, MD PhD
McLean Hospital McLean Hospital is a comprehensive psychiatric hospital committed to providing easy access to...
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