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.

Condition	Intervention
Schizophrenia Schizoaffective Disorder	Behavior: Team-Based Quality Improvement Intervention  Behavior: Opinion Leader Intervention

Further Study Details: 

Primary Outcomes: Antipsychotic dose above guideline-recommended range Side effect monitoring 30 days before/after new antipsychotic Clozapine prescribing for treatment-refractory schizophrenia
Secondary Outcomes: Patient functional status ?Improvement in schizophrenia symptoms Service Use
Expected Total Enrollment:  50

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 will employ 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 3-4 different VA health care networks (VISNs) will be 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 12 months, and 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.

Findings:

Qualitative survey assessments to characterize the structure and operation of network mental heath service lines have been completed with mental health leaders in VISNs meeting preliminary study criteria. Most of the VISNs were organized into task force models of mental health service line implementation (8/15; 53.3%). Other models observed were teams/councils (3/15; 20.0%), matrix models (3/15; 20.0%), and a modified division model (1/15; 6.7%). Almost all respondents reported that the network service line monitored performance measures and worked to promote improvement in performance measures when needed (14/15; 83.3%). The project is ongoing.

Status:

Sites in VISNs 8, 10, 16 and 17 are confirmed partners in the project. The ASSIST project team is developing and adapting an assortment of clinical tools and training materials designed to facilitate quality improvement in antipsychotic medication management. Work is ongoing to develop a reliable, computerized algorithm that can be used by participating sites to identify pa

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00156637

Arkansas
      Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock, No Little Rock,  Arkansas,  72114-1706,  United States; Recruiting
      Fayetteville, AR, Fayetteville,  Arkansas,  72703,  United States; Not yet recruiting
Florida
      Bay Pines, FL, Bay Pines,  Florida,  33708,  United States; Not yet recruiting
Louisiana
      VA Medical Center, New Orleans,  Louisiana,  70146,  United States; Not yet recruiting
Nevada
      VA Sierra Nevada Health Care System, Reno,  Nevada,  89502,  United States; Not yet recruiting
Texas
      Houston VA Medical Center, Houston,  Texas,  77030,  United States; Not yet recruiting

Study chairs or principal investigators

Richard R. Owen, MD,  Principal Investigator,  Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock   

Study ID Numbers:  MNT 02-210
Last Updated:  September 9, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00156637
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-13