Improving Antipsychotic Adherence Among Patients With Serious Mental Illness

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00057135
First received: March 27, 2003
Last updated: October 25, 2013
Last verified: April 2007
  Purpose

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.


Condition Intervention
Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
Behavioral: Unit of use medication packaging
Behavioral: Mailed reminders to patient when medication refills are due
Behavioral: Note to Mental Health Provider when refill is overdue
Procedure: Aligning all prescriptions to fall due on same date

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Improving Antipsychotic Adherence Among Patients With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: November 2002
Study Completion Date: September 2006
Arms Assigned Interventions
Arm 1 Behavioral: Unit of use medication packaging Behavioral: Mailed reminders to patient when medication refills are due Behavioral: Note to Mental Health Provider when refill is overdue Procedure: Aligning all prescriptions to fall due on same date

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00057135

Locations
United States, California
VA San Diego Health Care System
San Diego, California, United States, 92161
United States, Illinois
Edward Hines, Jr. VA Hospital
Hines, Illinois, United States, 60141-3030
United States, Michigan
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States, 48113-0170
John D. Dingell VA Medical Center
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Investigators
Principal Investigator: Marcia T. Valenstein, MD AB VA Ann Arbor Healthcare System
Principal Investigator: John Grabowski, MD VA Medical Center, Providence
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00057135     History of Changes
Other Study ID Numbers: IIR 01-074
Study First Received: March 27, 2003
Last Updated: October 25, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Schizophrenia
Treatment Refusal
Drug Packaging
Reminder Systems
Antipsychotic Agents

Additional relevant MeSH terms:
Bipolar Disorder
Psychotic Disorders
Schizophrenia
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on April 16, 2014