Improving Care and Reducing Cost Study

NCT ID: NCT02364544

Last Updated: 2017-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

461 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-06-30

Brief Summary

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The goal of the Improving Care and Reducing Cost (ICRC) Program, is to improve disease management and the overall process of care in treating the chronic illness schizophrenia in order to reduce ER visits and hospital days while providing better care, better health and increased patient satisfaction. This will be done by fostering innovation in the use of technology and by training and deploying a new cadre of personnel in the behavioral health field: Mental Health/Health Technology (MH/HT) Case Managers.

Detailed Description

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The goal of the Improving Care and Reducing Cost (ICRC) Program, is to improve disease management and the overall process of care in treating the chronic illness schizophrenia in order to reduce ER visits and hospital days while providing better care, better health and increased patient satisfaction. This will be done by fostering innovation in the use of technology and by training and deploying a new cadre of personnel in the behavioral health field: Mental Health/Health Technology (MH/HT) Case Managers. The specific treatments we propose to use are evidence based, but their dissemination has been limited because of lack of trained personnel and cost. The model we propose, the Health Technology Program (HTP), will address these problems through use of the web and mobile phone based training and interventions.

The components of the HTP program that are being tested in the pilot program include: 1) evidence-based pharmacological treatment facilitated by a web-based prescriber decision support system-Prescriber Decision Assistant (PDA) 2) brief, in-person, relapse prevention counseling with supplemental web-based learning modules, 3) a daily support website that offers web- and phone-based resources to support persons with schizophrenia and their family members or others. The resources include a patient and family Psycho-Education Treatment program, which includes electronic peer groups facilitated by mental health professionals, providing medication reminders via web and phone, and conducting monitoring of early warning signs of relapse via web and phone 4) an interactive smart phone text-messaging application to support medication adherence, facilitate coping with symptoms and improve daily functioning in individuals with schizophrenia 5) a web-based, self-administered cognitive-behavioral therapy (CBT) program for the management of hallucinations. All patients will be provided with pharmacological treatment (PDA), brief in-person relapse prevention counseling, and an Android mobile phone. The other program components will be provided to patients using a shared decision-making approach to assess need and preference.

Conditions

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Schizophrenia Schizoaffective Disorder Psychosis NOS

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Health Technology Program

The components of the treatment model include: 1) Prescriber Decision Assistant (PDA) 2) relapse prevention plan, 3) the daily support website 4) FOCUS, an interactive smart phone text-messaging application 5) a web-based, cognitive-behavioral therapy (CBT) program

All patients will be provided with pharmacological treatment (PDA), brief in-person relapse prevention counseling, and an Android mobile phone. The other program components will be provided to patients using a shared decision-making approach to assess need and preference.

Group Type OTHER

Relapse Prevention Plan

Intervention Type BEHAVIORAL

brief, in-person, relapse prevention counseling with supplemental web-based learning modules,

Daily Support Website

Intervention Type BEHAVIORAL

web-based program for patients and families that provides psychoeducation about schizophrenia and its treatments to improve knowledge, increase problem-solving skills and offer social support through the use of web-based therapist facilitated sessions

Computer CBT for voices and paranoia

Intervention Type BEHAVIORAL

A ten-session CBT programs, one to address voices and the other for paranoia. The web-based programs incorporate the essential elements of CBT for psychosis such as normalizing behavior and offering behavioral coping strategies

FOCUS

Intervention Type BEHAVIORAL

an interactive smart phone text-messaging application to support medication adherence, facilitate coping with symptoms and improve daily functioning in individuals with schizophrenia

Prescriber Decision Assistant

Intervention Type OTHER

is a web-based prescriber decision support system that includes a brief patient-completed assessment describing symptoms and adverse events which prompts the prescriber to conduct a detailed clinical assessment. Embedded in the program are decision supports for medication choices based on best evidence-based practices regarding symptoms, side effects, information from laboratory tests and history of prior treatment response

Interventions

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Relapse Prevention Plan

brief, in-person, relapse prevention counseling with supplemental web-based learning modules,

Intervention Type BEHAVIORAL

Daily Support Website

web-based program for patients and families that provides psychoeducation about schizophrenia and its treatments to improve knowledge, increase problem-solving skills and offer social support through the use of web-based therapist facilitated sessions

Intervention Type BEHAVIORAL

Computer CBT for voices and paranoia

A ten-session CBT programs, one to address voices and the other for paranoia. The web-based programs incorporate the essential elements of CBT for psychosis such as normalizing behavior and offering behavioral coping strategies

Intervention Type BEHAVIORAL

FOCUS

an interactive smart phone text-messaging application to support medication adherence, facilitate coping with symptoms and improve daily functioning in individuals with schizophrenia

Intervention Type BEHAVIORAL

Prescriber Decision Assistant

is a web-based prescriber decision support system that includes a brief patient-completed assessment describing symptoms and adverse events which prompts the prescriber to conduct a detailed clinical assessment. Embedded in the program are decision supports for medication choices based on best evidence-based practices regarding symptoms, side effects, information from laboratory tests and history of prior treatment response

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* • Age 18 to 60, (patients age 51-60 require review from the coordinating site)

* Clinical diagnosis of:

* schizophrenia
* schizoaffective disorder
* psychosis NOS
* Has had two or more inpatient hospitalizations for treatment of a psychotic disorder
* Currently in the hospital or up to 30 days of inpatient hospitalization for a psychotic disorder

o If patients are sent to a partial, or day hospital following an inpatient hospitalization, the 30 day window begins at the time of discharge from the day or partial hospital
* Any ethnicity
* Ability to participate in research assessments in English
* Ability to provide fully informed consent

Exclusion Criteria

* • Individuals who cannot understand what research participation entails, or correctly answer the questions about research participation that are part of the Study Information Review and provide fully informed consent will be excluded

* More than 30 days since discharge from a psychiatric hospitalization
* Any other serious medical condition that in the opinion of the investigator would seriously impair functioning making the patient unsuitable for the trial
* Patients who would likely find it burdensome and/or have difficulty sustaining the use of a laptop computer and /or smart phone due to issues of security, consistent connectivity or other factors.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pittsburgh

OTHER

Sponsor Role collaborator

Boston University

OTHER

Sponsor Role collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role collaborator

Northwell Health

OTHER

Sponsor Role lead

Responsible Party

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John Kane

Senior Vice President, Behavioral Health Services

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John Kane

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Locations

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Henderson Mental Health Center

Fort Lauderdale, Florida, United States

Site Status

Community Mental Health Center, Inc.

Lawrenceburg, Indiana, United States

Site Status

Cherry Street

Grand Rapids, Michigan, United States

Site Status

UMKC School of Pharmacy

Kansas City, Missouri, United States

Site Status

Burrell Behavioral Health

Springfield, Missouri, United States

Site Status

The Mental Health Center of Greater Manchester

Manchester, New Hampshire, United States

Site Status

University of New Mexico Department of Psychiatry UNM Health Sciences Center

Albuquerque, New Mexico, United States

Site Status

PeaceHealth Oregon/Lane County Behavioral Health Services

Eugene, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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ICRC

Identifier Type: -

Identifier Source: org_study_id

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