Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00057135
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2003-03-27
Brief Title:
Improving Antipsychotic Adherence Among Patients With Serious Mental Illness
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Improving Antipsychotic Adherence Among Patients With Schizophrenia
Status:
COMPLETED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None