SchizophreniaNCT00156637
A Study of Strategies to Improve Schizophrenia Treatment
A study testing Team-Based Quality Improvement Intervention, Opinion Leader Intervention and Team Based Quality Improvement in people with Schizophrenia and Schizoaffective Disorder, run by US Department of Veterans Affairs at 4 sites in United States.
Trial summary
The goal of this project is to translate research findings about key aspects of antipsychotic treatment into routine care through a multi-component intervention, focusing on improving two aspects of medication management that are directly linked to patient outcomes: 1) monitoring for potentially serious metabolic side… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Team-Based Quality Improvement Intervention, Opinion Leader Intervention and Team Based Quality Improvement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2005to Mar 2008
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- SITE: 300 or more patients with schizophrenia diagnosis Below national VA average on high antipsychotic dosing (dosing sites) or use of clozapine (clozapine sites)?Site leader buy-in
- PATIENT: Clinical diagnosis of schizophrenia or schizoaffective disorder
- 18-65 years of age Had at least 1 inpatient stays or outpatient visits to facility in past year [Dosing Sites] Filled antipsychotic prescription at dose that exceeds guideline recommendations in past 3 months [Clozapine Sites] Scores positive on computer routine to identify potential candidates for a trial of clozapine
Who cannot join
- SITE:No affiliation with an Institutional Review Board or Research and Development office for protocol review/approval PATIENT: No access to telephone Enrolled in a conflicting study
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Dayton VA Medical Center, Dayton, OH
Dayton, Ohio, 45428
Veterans Health Care System of the Ozarks, Fayetteville, AR
Fayetteville, Arkansas, 72703
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
No. Little Rock, Arkansas, 72114-1706
About this study
The goal of this project is to translate research findings about key aspects of antipsychotic treatment into routine care through a multi-component intervention, focusing on improving two aspects of medication management that are directly linked to patient outcomes: 1) monitoring for potentially serious metabolic side effects of newer antipsychotic medication, and 2) increasing the appropriate use of clozapine for treatment-refractory patients.
Read the detailed description
Background:
Antipsychotic medication is by far the most widely utilized treatment for schizophrenia in VA settings, and the VA has established guidelines for the appropriate use of these medications. The recent introduction of a new generation of antipsychotic medications has also offered great hope to persons with schizophrenia, but also may adversely affect health due to metabolic side effects. Improving all aspects of antipsychotic medication management is necessary to improve outcomes for persons with schizophrenia.
Objectives:
The goal of this project is to translate research findings about key aspects of antipsychotic treatment into routine care through a multi-component intervention. Mental Health QUERI's (MHQ) previous project for improving antipsychotic treatment demonstrated that a multi-component intervention improved use of guideline-recommended antipsychotic doses. This project will build on results and lessons learned from MHQ's previous translation project. The scope of translation will be expanded from an ongoing focus on reducing high antipsychotic doses to include two additional aspects of medication management that are directly linked to patient outcomes: 1) increasing monitoring for potentially serious side effects of newer antipsychotic medication, and 2) increasing the appropriate use of clozapine for treatment-refractory patients.
Methods:
The project is employing a multi-component intervention for improving antipsychotic prescribing while comparing the use of two different interpersonal marketing/influence strategies for translation. The primary objective is to compare the effectiveness of a team-based QI approach and a strategy using a clinical opinion leader augmented by an implementation coordinator to improve antipsychotic medication management. In addition, MHQ will determine the impact of a support and consultation program to promote clozapine prescribing. A total of ten VA Medical Centers from 4 different VA health care networks (VISNs) have been selected to participate on the basis of number of patients with schizophrenia, baseline performance on quality indicators, and organizational characteristics. Six of these sites will focus on side effect monitoring and antipsychotic dosing (two team-based QI, two clinical opinion leader, and two control), while two will receive the clozapine consultation program, with two matched control sites. Selected clinicians and staff (opinion leaders) will be identified and trained, and will implement the multi-component intervention consisting of educational materials and programs, information system tools, and performance monitoring and feedback. The intervention will take place for 6 months, and will be assessed with regard to improvement in side effect monitoring, high dose antipsychotic prescribing, and clozapine use. In addition, MHQ will assess impact of the intervention on patient outcomes at five of the sites.
Status:
In partnership with clinical stakeholders, the project team is implementing, adapting and evaluating an assortment of clinical tools and training materials designed to improve antipsychotic medication management. All, sites, except 1, have completed the intervention. All subject recruitment had been completed. The project team is also working with participating VAMC IT staff and Clinical Coordinators to fully automate the project's VISTA data extraction reoutines and performance monitoring reporting system for local implmentation and maintainence
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Team-Based Quality Improvement Intervention, Opinion Leader Intervention, Team Based Quality Improvement
- Keywords
- schizophrenia, quality of health care, quality indicators, intervention studies
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Team-Based Quality Improvement InterventionBehavioural
Intervention to improve recommended dosing and side effect monitoring of antipsychotic medications using a team-based quality improvement effort
Opinion Leader InterventionBehavioural
Intervention to improve recommended dosing and side effect monitoring of antpsychotic medications using an Opion leader quality improvement effort
Team Based Quality ImprovementBehavioural
Intervention to increase appropriate use of clozapine through a team based quality intervention.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: Behavioral: Team-Based Quality Improvement Intervention; Behavioral: Team Based Quality Improvement |
| Arm 2 | Active comparator | Dosing \& Side Effect Monitoring Receives: Behavioral: Opinion Leader Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antipsychotic dose above guideline-recommended range Side effect monitoring 30 days before/after new antipsychotic Clozapine prescribing for treatment-refractory schizophrenia
Measured: 6 months
Secondary outcomes (1)
Patient functional status ?Improvement in schizophrenia symptoms Service Use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionJan 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Richard R. Owen, MD, Principal investigator, Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00156637
- Sponsor's protocol ID
- MNT 02-210
- Status last verified
- Apr 2008
- First submitted
- 7 Sep 2005
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Rosen CS, Tiet QQ, Harris AH, Julian TF, McKay JR, Moore WM, Owen RR, Rogers S, Rosito O, Smith DE, Smith MW, Schnurr PP. Telephone monitoring and support after discharge from residential PTSD treatment: a randomized controlled trial. Psychiatr Serv. 2013 Jan;64(1):13-20. doi: 10.1176/appi.ps.201200142.
PubMed 23117443Young AS, Niv N, Chinman M, Dixon L, Eisen SV, Fischer EP, Smith J, Valenstein M, Marder SR, Owen RR. Routine outcomes monitoring to support improving care for schizophrenia: report from the VA Mental Health QUERI. Community Ment Health J. 2011 Apr;47(2):123-35. doi: 10.1007/s10597-010-9328-y. Epub 2010 Jul 25.
PubMed 20658320
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
- A Study of Strategies to Improve Schizophrenia Treatment
- ClinicalTrials.gov ID
- NCT00156637
- Acronym / sponsor ID
- MNT 02-210
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- schizophrenia, quality of health care, quality indicators, intervention studies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jun 2005
- Primary completion
- Jan 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 12 Sep 2005 (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.
The goal of this project is to translate research findings about key aspects of antipsychotic treatment into routine care through a multi-component intervention, focusing on improving two aspects of medication management that are directly linked to patient outcomes: 1) monitoring for potentially serious metabolic side effects of newer antipsychotic medication, and 2) increasing the appropriate use of clozapine for treatment-refractory patients.
Detailed description
Background:
Antipsychotic medication is by far the most widely utilized treatment for schizophrenia in VA settings, and the VA has established guidelines for the appropriate use of these medications. The recent introduction of a new generation of antipsychotic medications has also offered great hope to persons with schizophrenia, but also may adversely affect health due to metabolic side effects. Improving all aspects of antipsychotic medication management is necessary to improve outcomes for persons with schizophrenia.
Objectives:
The goal of this project is to translate research findings about key aspects of antipsychotic treatment into routine care through a multi-component intervention. Mental Health QUERI's (MHQ) previous project for improving antipsychotic treatment demonstrated that a multi-component intervention improved use of guideline-recommended antipsychotic doses. This project will build on results and lessons learned from MHQ's previous translation project. The scope of translation will be expanded from an ongoing focus on reducing high antipsychotic doses to include two additional aspects of medication management that are directly linked to patient outcomes: 1) increasing monitoring for potentially serious side effects of newer antipsychotic medication, and 2) increasing the appropriate use of clozapine for treatment-refractory patients.
Methods:
The project is employing a multi-component intervention for improving antipsychotic prescribing while comparing the use of two different interpersonal marketing/influence strategies for translation. The primary objective is to compare the effectiveness of a team-based QI approach and a strategy using a clinical opinion leader augmented by an implementation coordinator to improve antipsychotic medication management. In addition, MHQ will determine the impact of a support and consultation program to promote clozapine prescribing. A total of ten VA Medical Centers from 4 different VA health care networks (VISNs) have been selected to participate on the basis of number of patients with schizophrenia, baseline performance on quality indicators, and organizational characteristics. Six of these sites will focus on side effect monitoring and antipsychotic dosing (two team-based QI, two clinical opinion leader, and two control), while two will receive the clozapine consultation program, with two matched control sites. Selected clinicians and staff (opinion leaders) will be identified and trained, and will implement the multi-component intervention consisting of educational materials and programs, information system tools, and performance monitoring and feedback. The intervention will take place for 6 months, and will be assessed with regard to improvement in side effect monitoring, high dose antipsychotic prescribing, and clozapine use. In addition, MHQ will assess impact of the intervention on patient outcomes at five of the sites.
Status:
In partnership with clinical stakeholders, the project team is implementing, adapting and evaluating an assortment of clinical tools and training materials designed to improve antipsychotic medication management. All, sites, except 1, have completed the intervention. All subject recruitment had been completed. The project team is also working with participating VAMC IT staff and Clinical Coordinators to fully automate the project's VISTA data extraction reoutines and performance monitoring reporting system for local implmentation and maintainence
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Behavioral: Team-Based Quality Improvement Intervention, Behavioral: Team Based Quality Improvement |
| Arm 2 | Active comparator | Behavioral: Opinion Leader InterventionDosing \& Side Effect Monitoring |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- SITE: 300 or more patients with schizophrenia diagnosis Below national VA average on high antipsychotic dosing (dosing sites) or use of clozapine (clozapine sites)?Site leader buy-in
- PATIENT: Clinical diagnosis of schizophrenia or schizoaffective disorder
- 18-65 years of age Had at least 1 inpatient stays or outpatient visits to facility in past year [Dosing Sites] Filled antipsychotic prescription at dose that exceeds guideline recommendations in past 3 months [Clozapine Sites] Scores positive on computer routine to identify potential candidates for a trial of clozapine
Key exclusion criteria (1 listed)
- SITE:No affiliation with an Institutional Review Board or Research and Development office for protocol review/approval PATIENT: No access to telephone Enrolled in a conflicting study
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 |
|---|---|---|
| Team-Based Quality Improvement InterventionIntervention to improve recommended dosing and side effect monitoring of antipsychotic medications using a team-based quality improvement effort | Behavioural | Arm 1 |
| Opinion Leader InterventionIntervention to improve recommended dosing and side effect monitoring of antpsychotic medications using an Opion leader quality improvement effort | Behavioural | Arm 2 |
| Team Based Quality ImprovementIntervention to increase appropriate use of clozapine through a team based quality intervention. | Behavioural | Arm 1 |
Primary outcome
Antipsychotic dose above guideline-recommended range Side effect monitoring 30 days before/after new antipsychotic Clozapine prescribing for treatment-refractory schizophrenia
Time frame: 6 months
1 secondary outcome
Patient functional status ?Improvement in schizophrenia symptoms Service Use
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 23117443Rosen CS, Tiet QQ, Harris AH, Julian TF, McKay JR, Moore WM, Owen RR, Rogers S, Rosito O, Smith DE, Smith MW, Schnurr PP. Telephone monitoring and support after discharge from residential PTSD treatment: a randomized controlled trial. Psychiatr Serv. 2013 Jan;64(1):13-20. doi: 10.1176/appi.ps.201200142.
- Results publication: PubMed 20658320Young AS, Niv N, Chinman M, Dixon L, Eisen SV, Fischer EP, Smith J, Valenstein M, Marder SR, Owen RR. Routine outcomes monitoring to support improving care for schizophrenia: report from the VA Mental Health QUERI. Community Ment Health J. 2011 Apr;47(2):123-35. doi: 10.1007/s10597-010-9328-y. Epub 2010 Jul 25.
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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.
Richard R. Owen, MD principal investigator
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Team-Based Quality Improvement Intervention, Opinion Leader Intervention and Team Based Quality Improvement in people with Schizophrenia and Schizoaffective Disorder, run by US Department of Veterans Affairs at 4 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 3 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 4 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?
Antipsychotic dose above guideline-recommended range Side effect monitoring 30 days before/after new antipsychotic Clozapine prescribing for treatment-refractory schizophrenia (time frame: 6 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 NCT00156637, which also lists 2 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.