Improving Antipsychotic Adherence Among Patients With Serious Mental Illness

Schizophrenia Clinical Trial

Official title:

Improving Antipsychotic Adherence Among Patients With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00057135
• Other study ID #: IIR 01-074
• Status: Completed
• Phase: N/A
• First received: March 27, 2003
• Last updated: April 6, 2015
• Start date: November 2002
• Est. completion date: September 2006

Study information

• Verified date: April 2007
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Behavioral:
• Unit of use medication packaging

• Mailed reminders to patient when medication refills are due

• Note to Mental Health Provider when refill is overdue

Procedure:
• Aligning all prescriptions to fall due on same date

Locations

Country	Name	City	State
United States	VA Ann Arbor Healthcare System, Ann Arbor, MI	Ann Arbor	Michigan
United States	John D. Dingell VA Medical Center, Detroit, MI	Detroit	Rhode Island
United States	East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ	East Orange	Massachusetts
United States	Edward Hines Jr. VA Hospital, Hines, IL	Hines	Illinois
United States	VA San Diego Healthcare System, San Diego, CA	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (9)

Kreyenbuhl J, Valenstein M, McCarthy JF, Ganoczy D, Blow FC. Long-term combination antipsychotic treatment in VA patients with schizophrenia. Schizophr Res. 2006 May;84(1):90-9. Epub 2006 May 2. — View Citation

Kreyenbuhl JA, Valenstein M, McCarthy JF, Ganoczy D, Blow FC. Long-term antipsychotic polypharmacy in the VA health system: patient characteristics and treatment patterns. Psychiatr Serv. 2007 Apr;58(4):489-95. — View Citation

Milner KK, Valenstein M. A comparison of guidelines for the treatment of schizophrenia. Psychiatr Serv. 2002 Jul;53(7):888-90. — View Citation

Pfeiffer PN, Szymanski B, Dhawan N, Difranco D, Valenstein M, Zivin K. Is there an "unhealthy volunteer effect" in mental health outpatient research? Psychiatry Res. 2010 Apr 30;176(2-3):224-8. doi: 10.1016/j.psychres.2009.07.016. Epub 2010 Feb 1. — View Citation

Sajatovic M, Blow FC, Kales HC, Valenstein M, Ganoczy D, Ignacio RV. Age comparison of treatment adherence with antipsychotic medications among individuals with bipolar disorder. Int J Geriatr Psychiatry. 2007 Oct;22(10):992-8. — View Citation

Sajatovic M, Valenstein M, Blow F, Ganoczy D, Ignacio R. Treatment adherence with lithium and anticonvulsant medications among patients with bipolar disorder. Psychiatr Serv. 2007 Jun;58(6):855-63. — View Citation

Sajatovic M, Valenstein M, Blow FC, Ganoczy D, Ignacio RV. Treatment adherence with antipsychotic medications in bipolar disorder. Bipolar Disord. 2006 Jun;8(3):232-41. — View Citation

Valenstein M, Ganoczy D, McCarthy JF, Myra Kim H, Lee TA, Blow FC. Antipsychotic adherence over time among patients receiving treatment for schizophrenia: a retrospective review. J Clin Psychiatry. 2006 Oct;67(10):1542-50. — View Citation

Valenstein M, Kavanagh J, Lee T, Reilly P, Dalack GW, Grabowski J, Smelson D, Ronis DL, Ganoczy D, Woltmann E, Metreger T, Wolschon P, Jensen A, Poddig B, Blow FC. Using a pharmacy-based intervention to improve antipsychotic adherence among patients with — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.			No
Secondary	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			No