SchizophreniaNCT00057135
Improving Antipsychotic Adherence Among Patients With Serious Mental Illness
A study testing Unit of use medication packaging, Mailed reminders to patient when medication refills are due and Note to Mental Health Provider when refill is overdue in people with Schizophrenia and Schizoaffective Disorder, run by US Department of Veterans Affairs at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
- What is being tested?
- Unit of use medication packaging, Mailed reminders to patient when medication refills are due and Note to Mental Health Provider when refill is overdue
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 5 sitesUnited States
- Study dates
- Nov 2002to Sep 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105
John D. Dingell VA Medical Center, Detroit, MI
Detroit, Rhode Island, 48201
East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
East Orange, Massachusetts, 07018
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-5000
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161
About this study
Official title: Improving Antipsychotic Adherence Among Patients With Schizophrenia
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.
Read the 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.
- Conditions
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
- Being tested
- Unit of use medication packaging, Mailed reminders to patient when medication refills are due, Note to Mental Health Provider when refill is overdue, Aligning all prescriptions to fall due on same date
- Keywords
- Schizophrenia, Treatment Refusal, Drug Packaging, Reminder Systems, Antipsychotic Agents
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Bipolar Disorder, Treatment Refusal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unit of use medication packagingBehavioural
Mailed reminders to patient when medication refills are dueBehavioural
Note to Mental Health Provider when refill is overdueBehavioural
Aligning all prescriptions to fall due on same dateProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2003 (estimated)
- Study startNov 2002
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Marcia T. Valenstein, MD AB, Principal investigator, VA Ann Arbor Healthcare System, Ann Arbor, MIJohn Grabowski, MD, Principal investigator, John D. Dingell VA Medical Center, Detroit, MI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00057135
- Sponsor's protocol ID
- IIR 01-074
- Status last verified
- Apr 2007
- First submitted
- 27 Mar 2003
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16631354Milner 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.
PubMed 12096176Sajatovic 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.
PubMed 16696824Sajatovic 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.
PubMed 17323327Kreyenbuhl 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.
PubMed 17412850Valenstein 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.
PubMed 17107245Sajatovic 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.
PubMed 17535948Valenstein 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.
PubMed 19933540Pfeiffer 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.
PubMed 20122743
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Antipsychotic Adherence Among Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT00057135
- Acronym / sponsor ID
- IIR 01-074
- Conditions
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
- Keywords
- Schizophrenia, Treatment Refusal, Drug Packaging, Reminder Systems, Antipsychotic Agents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Nov 2002
- Study completion
- Sep 2006 (actual)
- First posted
- 28 Mar 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unit of use medication packaging | Behavioural | Arm 1 |
| Mailed reminders to patient when medication refills are due | Behavioural | Arm 1 |
| Note to Mental Health Provider when refill is overdue | Behavioural | Arm 1 |
| Aligning all prescriptions to fall due on same date | Procedure or surgery | Arm 1 |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
- Results publication: PubMed 16631354Kreyenbuhl 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.
- Results publication: PubMed 12096176Milner 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.
- Results publication: PubMed 16696824Sajatovic 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.
- Results publication: PubMed 17323327Sajatovic 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.
- Results publication: PubMed 17412850Kreyenbuhl 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.
- Results publication: PubMed 17107245Valenstein 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.
- Results publication: PubMed 17535948Sajatovic 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.
- Results publication: PubMed 19933540Valenstein 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.
- Results publication: PubMed 20122743Pfeiffer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcia T. Valenstein, MD AB principal investigator
VA Ann Arbor Healthcare System, Ann Arbor, MI
John Grabowski, MD principal investigator
John D. Dingell VA Medical Center, Detroit, MI
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unit of use medication packaging, Mailed reminders to patient when medication refills are due and Note to Mental Health Provider when refill is overdue in people with Schizophrenia and Schizoaffective Disorder, run by US Department of Veterans Affairs at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00057135, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015.