A Study of Strategies to Improve Schizophrenia Treatment

Sponsor

US Department of Veterans Affairs (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT00156637

Collaborator

(none)

106

Enrollment

Locations

Arms

Duration (Months)

26.5

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Schizoaffective Disorder	Behavioral: Team-Based Quality Improvement Intervention Behavioral: Opinion Leader Intervention Behavioral: Team Based Quality Improvement	N/A

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

Study Type:

Interventional

Actual Enrollment :

106 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Official Title:

A Study of Strategies to Improve Schizophrenia Treatment

Study Start Date :

Jun 1, 2005

Actual Primary Completion Date :

Jan 1, 2007

Actual Study Completion Date :

Mar 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Other: Arm 1	Behavioral: Team-Based Quality Improvement Intervention Intervention to improve recommended dosing and side effect monitoring of antipsychotic medications using a team-based quality improvement effort Behavioral: Team Based Quality Improvement Intervention to increase appropriate use of clozapine through a team based quality intervention.
Active Comparator: Arm 2 Dosing & Side Effect Monitoring	Behavioral: Opinion Leader Intervention Intervention to improve recommended dosing and side effect monitoring of antpsychotic medications using an Opion leader quality improvement effort

Arm

Intervention/Treatment

Other: Arm 1

Behavioral: Team-Based Quality Improvement Intervention

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

Behavioral: Team Based Quality Improvement

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

Active Comparator: Arm 2

Dosing & Side Effect Monitoring

Behavioral: Opinion Leader Intervention

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

Outcome Measures

Primary Outcome Measures

Antipsychotic dose above guideline-recommended range Side effect monitoring 30 days before/after new antipsychotic Clozapine prescribing for treatment-refractory schizophrenia [6 months]

Secondary Outcome Measures

Patient functional status ?Improvement in schizophrenia symptoms Service Use []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Veterans Health Care System of the Ozarks, Fayetteville, AR	Fayetteville	Arkansas	United States	72703
2	Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR	No. Little Rock	Arkansas	United States	72114-1706
3	Dayton VA Medical Center, Dayton, OH	Dayton	Ohio	United States	45428
4	Michael E. DeBakey VA Medical Center, Houston, TX	Houston	Texas	United States	77030