NCT02364544

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
461

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 18, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

March 23, 2017

Status Verified

March 1, 2017

Enrollment Period

2.2 years

First QC Date

January 30, 2015

Last Update Submit

March 22, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Total Number of Hospitalization and Emergency Room Visits

    Captures the number of hospital and ER visits each month

    Baseline, Month 1, Month2, Month 3, Month4, Month 5, and Month 6

Secondary Outcomes (2)

  • Service Utilization Resource Form

    Baseline, month 3, month 6

  • Change from Baseline Heinrich's Quality of Life Scale

    Baseline and month 6

Study Arms (1)

Health Technology Program

OTHER

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.

Behavioral: Relapse Prevention PlanBehavioral: Daily Support WebsiteBehavioral: Computer CBT for voices and paranoiaBehavioral: FOCUSOther: Prescriber Decision Assistant

Interventions

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

Health Technology Program

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

Health Technology Program

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

Health Technology Program
FOCUSBEHAVIORAL

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

Health Technology Program

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

Health Technology Program

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Henderson Mental Health Center

Fort Lauderdale, Florida, 33319, United States

Location

Community Mental Health Center, Inc.

Lawrenceburg, Indiana, 47025, United States

Location

Cherry Street

Grand Rapids, Michigan, 49503, United States

Location

UMKC School of Pharmacy

Kansas City, Missouri, 64108, United States

Location

Burrell Behavioral Health

Springfield, Missouri, 65802, United States

Location

The Mental Health Center of Greater Manchester

Manchester, New Hampshire, 03101, United States

Location

University of New Mexico Department of Psychiatry UNM Health Sciences Center

Albuquerque, New Mexico, 87131, United States

Location

PeaceHealth Oregon/Lane County Behavioral Health Services

Eugene, Oregon, 97401, United States

Location

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersMental Disorders

Interventions

Voice

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders

Intervention Hierarchy (Ancestors)

Respiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • John Kane

    Northwell Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Vice President, Behavioral Health Services

Study Record Dates

First Submitted

January 30, 2015

First Posted

February 18, 2015

Study Start

April 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

March 23, 2017

Record last verified: 2017-03

Locations