Skip to content

Improving Antipsychotic Adherence Among Patients With Serious Mental Illness

Improving Antipsychotic Adherence Among Patients With Schizophrenia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00057135
Enrollment
150
Registered
2003-03-28
Start date
2002-11-30
Completion date
2006-09-30
Last updated
2015-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder, Schizoaffective Disorder, Schizophrenia

Keywords

Schizophrenia, Treatment Refusal, Drug Packaging, Reminder Systems, Antipsychotic Agents

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALUnit of use medication packaging
BEHAVIORALMailed reminders to patient when medication refills are due
BEHAVIORALNote to Mental Health Provider when refill is overdue
PROCEDUREAligning all prescriptions to fall due on same date

Sponsors

US Department of Veterans Affairs
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026