Improving Antipsychotic Adherence Among Patients With Serious Mental Illness
1 other identifier
interventional
150
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable schizophrenia
Started Nov 2002
Typical duration for not_applicable schizophrenia
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2002
CompletedFirst Submitted
Initial submission to the registry
March 27, 2003
CompletedFirst Posted
Study publicly available on registry
March 28, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedApril 7, 2015
April 1, 2007
March 27, 2003
April 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 (1)
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
Study Arms (1)
Arm 1
OTHERInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161, United States
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-5000, United States
East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
East Orange, Massachusetts, 07018, United States
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105, United States
John D. Dingell VA Medical Center, Detroit, MI
Detroit, Rhode Island, 48201, United States
Related 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. doi: 10.1016/j.schres.2006.02.023. Epub 2006 May 2.
PMID: 16631354RESULTMilner KK, Valenstein M. A comparison of guidelines for the treatment of schizophrenia. Psychiatr Serv. 2002 Jul;53(7):888-90. doi: 10.1176/appi.ps.53.7.888.
PMID: 12096176RESULTSajatovic 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. doi: 10.1111/j.1399-5618.2006.00314.x.
PMID: 16696824RESULTSajatovic 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. doi: 10.1002/gps.1777.
PMID: 17323327RESULTKreyenbuhl 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. doi: 10.1176/ps.2007.58.4.489.
PMID: 17412850RESULTValenstein 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. doi: 10.4088/jcp.v67n1008.
PMID: 17107245RESULTSajatovic 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. doi: 10.1176/ps.2007.58.6.855.
PMID: 17535948RESULTValenstein 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 serious mental illness. Schizophr Bull. 2011 Jul;37(4):727-36. doi: 10.1093/schbul/sbp121. Epub 2009 Nov 21.
PMID: 19933540RESULTPfeiffer 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.
PMID: 20122743RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marcia T. Valenstein, MD AB
VA Ann Arbor Healthcare System, Ann Arbor, MI
- PRINCIPAL INVESTIGATOR
John Grabowski, MD
John D. Dingell VA Medical Center, Detroit, MI
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2003
First Posted
March 28, 2003
Study Start
November 1, 2002
Study Completion
September 1, 2006
Last Updated
April 7, 2015
Record last verified: 2007-04