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Home > "I" Clinical Trials Conditions > Improving Antipsychotic Adherence Among Patients with Schizophrenia  Improving Antipsychotic Adherence Among Patients with Schizophrenia
Improving Antipsychotic Adherence Among Patients with Schizophrenia
For Condition: Schizophrenia,Schizoaffective Disorder
Status: Not yet recruiting
Sponsor(s): Department of Veterans Affairs ,
Synopsis: The purpose of this study is to examine the effectiveness of a practical, pharmacy-based intervention for improving adherence among patients with schizophrenia.
Details: Anti-psychotic medications are an essential component of the treatment of patients with schizophrenia. Unfortunately, pharmacy data indicate that 40% of VA patients with schizophrenia are poorly adherent with their antipsychotics. These patients are at much greater risk for hospitalization. We will examine the effectiveness of a practical, pharmacy-based intervention for improving adherence among patients with schizophrenia. Specifically, we will examine whether the Pharmacy Based Adherence Facilitation (PBAF) intervention improves medication adherence, increases patient satisfaction with medical care, decreases psychiatric symptoms, and decreases inpatient utilization. We will also determine the relative effectiveness of PBAF intervention among patients with varying: a) degrees of cognitive limitations, b) degrees of insight into their illness, and c) attitudes towards their medications. Using pharmacy and other data from the National VA Psychosis Registry, we will identify approximately 429 patients with schizophrenia and poor antipsychotic adherence in the year preceding study initiation. These patients must have completed at least two outpatient psychiatric visits at one of the study sites (Ann Arbor, Detroit, or San Diego VAs). From this list of patients, we will enroll 174 patients. Patients will be randomized to: 1) usual care; or 2) the Pharmacy Based Adherence Facilitation (PBAF) intervention. The PBAF intervention will consist of usual care plus: 1) "unit-of-use" adherence packaging; 2) a patient education session; 3) refill reminders; and 4) clinician notification of missed fills. Patient assessments will be conducted at baseline, 6 months, 12 months, and 18 months. The primary outcome measure will be medication adherence as measured by the medication possession ratio, and verified by self-report and antipsychotic blood levels. Patients’ level of psychiatric symptoms, quality of life, and satisfaction will be secondary measures of outcome. In secondary analyses, we will compare the effectiveness of the PBAF intervention among subgroups of patients who have varying degrees of cognitive limitations, insight into their illness, and attitudes towards antipsychotic medication.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Patients must be adult veterans with a diagnosis of schizophrenia or schizoaffective disorder, with at least one oral antipsychotic prescription and a history of poor adherence Exclusion Criteria: Patients are not eligible if they: - Have received depot antipsychotics in the last year - Have supervised medication administration - Have not attended a VA outpatient appointment in the past 6 months, and none are scheduled - Are prescribed Clozapine - Have a fatal illness with a life expectancy less than 2 years
Total Enrollment: 175
Location and Contact Information:
Additional Information:
Study ID Numbers: IIR 01-074;
Study Start Date: July 2002
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00057135
Other Schizophrenia Studies:
1. Genetic Study of Schizophrenia
2. Cognitive - Behavioral Therapy
3. To Determine If Olanzapine Is More Cost Effective Than Haloperidol for the Treatment of Schizophrenia
4. Efficacy and safety of two atypical antipsychotics vs. placebo in patients with an acute exacerbation of either schizophrenia or schizoaffective disorder
5. Effects of Modafinil on Brain Function in Patients with Schizophrenia
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Improving Antipsychotic Adherence Among Patients with Schizophrenia
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