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Completed

NCT Number: NCT02364544

Improving Care and Reducing Cost Study

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henderson Mental Health Center, Fort Lauderdale, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Relapse Prevention Plan

Behavioral

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

Daily Support Website

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

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

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

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

Primary outcomes

  1. Total Number of Hospitalization and Emergency Room Visits

    Time frame: Baseline, Month 1, Month2, Month 3, Month4, Month 5, and Month 6

    Captures the number of hospital and ER visits each month

Secondary outcomes

  1. Service Utilization Resource Form

    Time frame: Baseline, month 3, month 6

    Captures services received in the last 30 days

  2. Change from Baseline Heinrich's Quality of Life Scale

    Time frame: Baseline and month 6

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Collaborators

  • Boston University
  • Dartmouth-Hitchcock Medical Center
  • University of Pittsburgh

Registry information

Official study title

The Improving Care and Reducing Cost (ICRC) Program

Acronym: ICRC

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Feb 18, 2015
Registry last updated
Mar 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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