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Improving Care and Reducing Cost Study (ICRC)

Primary Purpose

Schizophrenia, Schizoaffective Disorder, Psychosis NOS

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Relapse Prevention Plan
Daily Support Website
Computer CBT for voices and paranoia
FOCUS
Prescriber Decision Assistant
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Henderson Mental Health Center
  • Community Mental Health Center, Inc.
  • Cherry Street
  • UMKC School of Pharmacy
  • Burrell Behavioral Health
  • The Mental Health Center of Greater Manchester
  • University of New Mexico Department of Psychiatry UNM Health Sciences Center
  • PeaceHealth Oregon/Lane County Behavioral Health Services

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Health Technology Program

Arm Description

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.

Outcomes

Primary Outcome Measures

Total Number of Hospitalization and Emergency Room Visits
Captures the number of hospital and ER visits each month

Secondary Outcome Measures

Service Utilization Resource Form
Captures services received in the last 30 days
Change from Baseline Heinrich's Quality of Life Scale

Full Information

First Posted
January 30, 2015
Last Updated
March 22, 2017
Sponsor
Northwell Health
Collaborators
University of Pittsburgh, Boston University, Dartmouth-Hitchcock Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02364544
Brief Title
Improving Care and Reducing Cost Study
Acronym
ICRC
Official Title
The Improving Care and Reducing Cost (ICRC) Program
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health
Collaborators
University of Pittsburgh, Boston University, Dartmouth-Hitchcock Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder, Psychosis NOS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
461 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Health Technology Program
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Relapse Prevention Plan
Intervention Description
brief, in-person, relapse prevention counseling with supplemental web-based learning modules,
Intervention Type
Behavioral
Intervention Name(s)
Daily Support Website
Intervention Description
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
Intervention Name(s)
Computer CBT for voices and paranoia
Intervention Description
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
Intervention Name(s)
FOCUS
Intervention Description
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
Other
Intervention Name(s)
Prescriber Decision Assistant
Intervention Description
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
Primary Outcome Measure Information:
Title
Total Number of Hospitalization and Emergency Room Visits
Description
Captures the number of hospital and ER visits each month
Time Frame
Baseline, Month 1, Month2, Month 3, Month4, Month 5, and Month 6
Secondary Outcome Measure Information:
Title
Service Utilization Resource Form
Description
Captures services received in the last 30 days
Time Frame
Baseline, month 3, month 6
Title
Change from Baseline Heinrich's Quality of Life Scale
Time Frame
Baseline and month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Kane
Organizational Affiliation
Northwell Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henderson Mental Health Center
City
Ft Lauderdale
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Community Mental Health Center, Inc.
City
Lawrenceburg
State/Province
Indiana
ZIP/Postal Code
47025
Country
United States
Facility Name
Cherry Street
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
UMKC School of Pharmacy
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Burrell Behavioral Health
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65802
Country
United States
Facility Name
The Mental Health Center of Greater Manchester
City
Manchester
State/Province
New Hampshire
ZIP/Postal Code
03101
Country
United States
Facility Name
University of New Mexico Department of Psychiatry UNM Health Sciences Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
PeaceHealth Oregon/Lane County Behavioral Health Services
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States

12. IPD Sharing Statement

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