NCT Number: NCT00057135
Improving Antipsychotic Adherence Among Patients With Serious Mental Illness
This is a randomized controlled trial examining the effectiveness of a pharmacy-based intervention designed to improve adherence with antipsychotic medications among patients with serious mental illness.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
VA San Diego Healthcare System, San Diego, CA, San Diego, California, United States
About this study
Background: 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. Objectives: We are examining the effectiveness of a practical, pharmacy-based intervention for improving antipsychotic adherence among patients with serious mental illness (SMI). Specifically, we are examining whether this pharmacy-based intervention increases antipsychotic medication adherence and patient satisfaction with care and decreases psychiatric symptoms, and inpatient utilization. We are also examining the relative effectiveness of the pharmacy-based intervention among patients with varying: a) degrees of cognitive limitations, b) degrees of insight into their illness, and c) attitudes towards their medications. Methods: Using pharmacy and administrative data, we are identifying patients with schizophrenia, schizoaffective disorder, or severe bipolar disorder requiring antipsychotic medication who have had poor antipsychotic adherence in the previous year. Patients must have completed at least two outpatient psychiatric visits at one of the study sites. Patients are randomized to: 1) usual care; or 2) the Pharmacy Based intervention. The pharmacy-based intervention consists 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. In-person patient assessments are conducted at baseline, 6 months, and 12 months following randomization. Medical record and administrative data will be collected at baseline, 6 months, 12 months, and 18 months following randomization. The primary outcome measure is medication adherence as measured by the medication possession ratio and adherence categories which combine pharmacy information with patient self-report and antipsychotic blood levels. Patients� level of psychiatric symptoms, quality of life, and satisfaction are secondary outcome measures. In supplemental analyses, we will compare the effectiveness of the pharmacy-based intervention among subgroups of patients who have varying degrees of cognitive limitations, insight into their illness, and attitudes towards antipsychotic medication. Findings: One hundred and fifty patients have been enrolled in the study. Follow-up rates have been high, with 90% of patients completing 6 month follow up assessments and 80% completing 12 month assessments. In person follow up visits are now complete.
Findings regarding the accuracy of administrative diagnoses of schizophrenia, the accuracy of pharmacy data in identifying patients with poor adherence, and patient factors associated with study recruitment have been presented at national meetings. Main study analyses are now ongoing. 6. Status: Enrollment and inperson-patient follow up are complete. Study analyses are now in progress. Impact: Improving adherence among SMI patients is critical to improving their outcomes. This study examines the effectiveness of a practical, low-cost intervention to for these vulnerable patients.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients must be adult veterans. Diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder. At least one active oral antipsychotic prescription. History of poor medication compliance.
Exclusion criteria
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.
Treatment and study plan
Mailed reminders to patient when medication refills are due
BehavioralNote to Mental Health Provider when refill is overdue
BehavioralAligning all prescriptions to fall due on same date
ProcedurePrimary outcomes
-
Medication Possession Ratio at baseline, 1-6 months, 6-12 months, and 12-18 months. Aggregate adherence categories based on MPR, anti-psychotic blood levels (present/not present) and patient self-report at baseline, 6 months, and 12 months.
Secondary outcomes
-
Positive and Negative Syndrome Scale for Schizophrenia, Client Satisfaction Questionnaire, Quality of Well-Being Scale. All to be administered at baseline, 6 months, and 12 months after enrollment
Sponsors and collaborators
Lead sponsor
US Department of Veterans Affairs
Fed
Registry information
Official study title
Improving Antipsychotic Adherence Among Patients With Schizophrenia
Important dates
- Study start
- 2002
- Study completion
- 2006
- First posted
- Mar 28, 2003
- Registry last updated
- Apr 7, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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