Implementation Trial of Evidence Based Practices for Mood Disorders

The objective of this Implementation Trial is to evaluate the implementation of evidence
based practices for Bipolar Disorder and Treatment Resistant Depression in small rural
Federally Qualified Health Centers. The evidence based practices were chosen and adapted by
Health Center providers and patients in consultation with clinical experts. The evidence
based practices include: screening for and diagnosing Bipolar Disorder, prescribing one of
five mood stabilizers, on-line cognitive behavioral therapy (Beating the Blues), on-line peer
support (Depression and Bipolar Support Alliance), collaborative care management and
tele-psychiatry consultation. These evidence based practices were chosen based on the
strength of the research evidence and the feasibility of implementation in small primary
clinics serving a low income rural patient population. Providers may choose to use all, any
or none of the evidence based practices with their patients. Patients may choose to adhere to
all, any, or none of the treatment recommendations prescribed by their provider.

A quasi-experimental study design will be used. There are Federally Qualified Health Centers
participating in the Implementation Trial. Each Federally Qualified Health Center chose one
implementation clinic and one control clinic. Patients will be enrolled from both
implementation and control clinics and outcomes will be compared for the three month period
following enrollment. Implementation outcomes are based on the "RE-AIM" framework and
include: reach, adoption, implementation-fidelity and effectiveness. Reach represents the
proportion of patients who receive evidence based practices. Reach will be compiled at the
patient level. Adoption represents the proportion of providers delivering evidence based
practices. Provider adoption will be compiled at the primary care provider level.
Implementation-Fidelity represents whether the evidence based practices are being delivered
as intended. Implementation will be compiled at the patient level. Effectiveness represents
the clinical improvement experienced by patients. Effectiveness will be compiled at the
patient level. Data will be collected from chart review and patient surveys will be
administered by an Interactive Voice Response telephone system.

There will be three samples. The Full Sample will be all patients screening positive for
depression on the Patient Health Questionnaire (PHQ9) screening tool during the 9 month
enrollment period. The PHQ9 is used to routinely screen patients for depression at
participating clinics. The Full Sample is expected to include approximately 2,400 patients.
The Bipolar Depression Sample will be patients screening positive for depression, screening
positive for Bipolar Disorder (on the CIDI), and providing informed consent to collect
primary data. The Treatment Resistant Depression Sample will be patients screening positive
for depression, screening negative for Bipolar Disorder, currently prescribed an
antidepressant, and providing informed consent to collect primary data. The purpose of the
"currently prescribed an antidepressant" inclusion criterion is to identify patients who do
not respond to treatment. This inclusion criterion will be determined from chart review. We
expect approximately 40 patients from each of six Federally Qualified Health Centers (two
clinics per system) to be eligible for the Bipolar Depression and Treatment Resistant
Depression samples and to provide informed consent. Thus, the combined size of the Bipolar
Depression and Treatment Resistant Depression samples is expected to be 240.

Health Center evaluation staff will test differences in patient outcomes at implementation
and control sites using ordinary least squares and logistic regression analyses that will
control for demographic characteristics. Compared to patients at control sites, we
hypothesize that patients with a positive depression screen at implementation sites will be
more likely to be screened for Bipolar Disorder than patients at control sites. With
automated chart review data for 2,400 patients, we will have 84% power to detect a 5% (e.g.,
25% versus 20%) difference in Bipolar Disorder screening rates. Compared to patients at
control sites, we hypothesize that patients in the Bipolar Disorder Sample at implementation
sites will be more likely to see receive a Bipolar diagnosis, be prescribed a mood
stabilizer, engage in on-line cognitive behavioral therapy, engage in on-line peer support,
receive collaborative care management, have a tele-psychiatry consultation, experience
depression symptom improvement and report greater satisfaction. For the Bipolar Disorder
Sample, we plan to enroll approximately 20 patients from each of six Federally Qualified
Health Centers (two clinics per system) and expect at least a 75% follow-up rate (n=90),
which will give us 79% power to detect a 25% (e.g., 15% versus 40%) difference in Bipolar
Disorder specific outcomes (e.g., diagnosed with Bipolar Disorder). Compared to patients at
control sites, we hypothesize that patients in the Treatment Resistant Depression Sample at
implementation sites will be more likely to have their antidepressant prescription changed,
engage in on-line cognitive behavioral therapy, engage in on-line peer support, receive
collaborative care management, have a tele-psychiatry consultation, experience depression
symptom improvement and report greater satisfaction. For the Treatment Resistant Depression
Sample, we plan to enroll approximately 20 patients from each of six Federally Qualified
Health Centers (two clinics per system) and expect at least a 75% follow-up rate (n=90),
which will give us 79% power to detect a 25% (e.g., 15% versus 40%) difference in Treatment
Resistant Depression specific outcomes (e.g., antidepressant prescription changed). For the
combined Bipolar Disorder Sample and Treatment Resistant Depression Sample, we plan to enroll
approximately 40 patients from each of six Federally Qualified Health Centers (two clinics
per system) and expect at least a 75% follow-up rate (n=180), which will give us 87% power to
detect a 15% (e.g., 25% versus 40%) difference in trans-diagnostic outcomes (e.g.,
satisfaction).

Inclusion Criteria:

Full sample - screening positive for depression Bipolar Disorder sample - screening
positive for depression, screening positive for bipolar disorder, not currently in a manic
state Treatment Resistant Depression - screening positive for depression, screening
negative for bipolar disorder, currently prescribed an antidepressant by primary care
provider

Exclusion Criteria:

Full sample - none Bipolar Disorder sample - currently in a manic state Treatment Resistant
Depression - none