Implementation Trial of Evidence Based Practices for Mood Disorders
Condition: Bipolar Disorder; Treatment Resistant Depression
MeSH terms: Bipolar Disorder; Depressive Disorder, Treatment-Resistant
Study type: Interventional

Summary: 
      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 chosen and adapted by Health
      Center providers and patients in consultation with clinical experts include: screening for
      and diagnosing Bipolar Disorder, prescribing mood stabilizers, on-line cognitive behavioral
      therapy, on-line peer support, collaborative care management and tele-psychiatry
      consultation. A quasi-experimental study design will be used, with each of the six
      participating Federally Qualified Health Centers choosing one implementation clinic and one
      control clinic. Implementation outcomes include: reach, adoption, implementation-fidelity and
      effectiveness. Providers and patients may choose to use all, any or none of the evidence
      based practices based on their needs and preferences. Data will be collected from chart
      review and patient surveys will be administered by an Interactive Voice Response telephone
      system.
    

Detailed description: 
      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).
    

Intervention name(s): Evidence Based Quality Improvement
Intervention type(s): Behavioral
Intervention description(s): Facilitation of the identification, adoption, adaption and implementation of evidence based practices.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Screening; Mood Stabilizers; Computer delivered psychotherapy; Peer Support; Telepsychiatry; Implementation; Rural