A Study of Strategies to Improve Schizophrenia Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00156637
First received: September 7, 2005
Last updated: October 25, 2013
Last verified: April 2008
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Study of Strategies to Improve Schizophrenia Treatment

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient functional status ?Improvement in schizophrenia symptoms Service Use [ Designated as safety issue: No ]

Enrollment: 106
Study Start Date: June 2005
Study Completion Date: March 2008
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00156637

Locations
United States, Arkansas
Fayetteville, AR
Fayetteville, Arkansas, United States, 72703
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
No. Little Rock, Arkansas, United States, 72114-1706
United States, Ohio
Dayton, OH
Dayton, Ohio, United States, 45428
United States, Texas
Michael E DeBakey VA Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Investigators
Principal Investigator: Richard R. Owen, MD Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00156637     History of Changes
Other Study ID Numbers: MNT 02-210
Study First Received: September 7, 2005
Last Updated: October 25, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
schizophrenia
quality of health care
quality indicators
intervention studies

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on September 16, 2014