NCT00156637

Brief 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 effects of newer antipsychotic medication, and 2) increasing the appropriate use of clozapine for treatment-refractory patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Jun 2005

Geographic Reach
1 country

4 active sites

Status
completed

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

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

April 7, 2015

Status Verified

April 1, 2008

Enrollment Period

1.6 years

First QC Date

September 7, 2005

Last Update Submit

April 6, 2015

Conditions

SchizophreniaSchizoaffective Disorder

Keywords

schizophreniaquality of health carequality indicatorsintervention studies

Outcome Measures

Primary Outcomes (1)

  • Antipsychotic dose above guideline-recommended range Side effect monitoring 30 days before/after new antipsychotic Clozapine prescribing for treatment-refractory schizophrenia

    6 months

Secondary Outcomes (1)

  • Patient functional status ?Improvement in schizophrenia symptoms Service Use

Study Arms (2)

Arm 1

OTHER
Behavioral: Team-Based Quality Improvement InterventionBehavioral: Team Based Quality Improvement

Arm 2

ACTIVE COMPARATOR

Dosing \& Side Effect Monitoring

Behavioral: Opinion Leader Intervention

Interventions

Team-Based Quality Improvement InterventionBEHAVIORAL

Intervention to improve recommended dosing and side effect monitoring of antipsychotic medications using a team-based quality improvement effort

Arm 1
Opinion Leader InterventionBEHAVIORAL

Intervention to improve recommended dosing and side effect monitoring of antpsychotic medications using an Opion leader quality improvement effort

Arm 2
Team Based Quality ImprovementBEHAVIORAL

Intervention to increase appropriate use of clozapine through a team based quality intervention.

Arm 1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Veterans Health Care System of the Ozarks, Fayetteville, AR

Fayetteville, Arkansas, 72703, United States

Location

Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR

No. Little Rock, Arkansas, 72114-1706, United States

Location

Dayton VA Medical Center, Dayton, OH

Dayton, Ohio, 45428, United States

Location

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030, United States

Location

Related Publications (2)

  • 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.

    PMID: 23117443RESULT

  • Young 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.

    PMID: 20658320RESULT

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Richard R. Owen, MD

    Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 12, 2005

Study Start

June 1, 2005

Primary Completion

January 1, 2007

Study Completion

March 1, 2008

Last Updated

April 7, 2015

Record last verified: 2008-04

Locations

US(4)