Patient-Centered Medication Adherence Intervention for Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      Efficacious antipsychotic medication treatments for schizophrenia are available; however ,
      antipsychotic regimens frequently do not achieve their potential because of poor medication
      adherence. To date, medication adherence interventions have not been widely adopted or
      sustained in "real-world" practice settings. One reason for this is the substantial resource
      investment necessary to implement and sustain available interventions. In response to these
      problems, we developed a patient-centered adherence intervention based on patient-identified
      barriers, facilitators, and motivators (BFMs) for medication adherence. The intervention
      includes a BFM survey (checklist and preference weighting exercise to determine the patient's
      most important BFM) and a brief list of adherence enhancing suggestions (Options List)
      tailored to the patient-identified BFMs and compatible with CPRS. The long-term objective of
      this proposed research is to improve antipsychotic medication adherence and clinical outcomes
      for patients with schizophrenia using a cost-effective medication adherence intervention. The
      short-term objectives are to refine and test a patient-centered medication adherence
      intervention for VA patients with schizophrenia and specifically to: 1. Enhance the
      feasibility and acceptability of the BFM intervention by reducing the burden on patients and
      mental health providers through BFM checklist item reduction, provider intervention input,
      and patient intervention input. We hypothesize that our use of end-user input will result in
      at least 80% of intervention patients having documentation of a BFM intervention in CPRS. 2.
      Compare the effects of the BFM intervention versus usual care on changes in medication
      adherence and schizophrenia symptom severity. We hypothesize that the intervention will
      result in a) greater medication adherence and b) lower schizophrenia symptom severity than
      usual care. 3. Exploratory objective: compare the effects of the BFM intervention versus
      usual care on changes in patient health-related quality of life. We hypothesize that the
      intervention will result in greater health-related quality of life than usual care.
    

Detailed description: 
      BFM intervention refinement will be accomplished in five phases. Phase one will include
      reducing the number of items in the BFM checklist by administering the expanded checklist to
      at least 50 patients with schizophrenia and using the standard psychometric item-reduction
      strategies to create a shorter checklist. In phase two we will conduct mental health provider
      focus groups to discuss the content of the Options List and the delivery of the intervention.
      In phase three we will automate the BFM intervention using an existing web-based computer
      touch-screen platform. In phase four we will conduct individual patient debriefing interviews
      with 30 patients to evaluate the understandability of the BFM survey. In phase five we will
      evaluate the test/re-test reliability of the survey in a new sample of 30 patients. BFM
      intervention implementation will include a stratified randomization of patients to the BFM
      intervention or usual care. BFM intervention evaluation will include testing the feasibility,
      acceptability, and outcomes associated with the intervention versus usual care in a single
      trial with 200 patients (100 intervention and 100 usual care).
    

Intervention name(s): Antipsychotic medication adherence intervention
Intervention type(s): Behavioral
Intervention description(s): The medication adherence intervention will include using a computer to complete a brief set of questions related to medication adherence before mental health clinic visits.
Intervention MeSH terms: Antipsychotic Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Keywords: patient non-adherence; intervention studies