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Improving Care and Reducing Cost Study (ICRC)

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ClinicalTrials.gov Identifier: NCT02364544
Recruitment Status : Completed
First Posted : February 18, 2015
Last Update Posted : March 23, 2017
Sponsor:
Collaborators:
University of Pittsburgh
Boston University
Dartmouth-Hitchcock Medical Center
Information provided by (Responsible Party):
John Kane, Northwell Health

Tracking Information
First Submitted Date  ICMJE January 30, 2015
First Posted Date  ICMJE February 18, 2015
Last Update Posted Date March 23, 2017
Study Start Date  ICMJE April 2013
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2015)
  • Service Utilization Resource Form [ Time Frame: Baseline, month 3, month 6 ]
    Captures services received in the last 30 days
  • Change from Baseline Heinrich's Quality of Life Scale [ Time Frame: Baseline and month 6 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving Care and Reducing Cost Study
Official Title  ICMJE The Improving Care and Reducing Cost (ICRC) Program
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Schizophrenia
  • Schizoaffective Disorder
  • Psychosis NOS
Intervention  ICMJE
  • Behavioral: Relapse Prevention Plan
    brief, in-person, relapse prevention counseling with supplemental web-based learning modules,
  • 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
  • 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
  • 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
  • Other: 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
Study Arms  ICMJE 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.

Interventions:
  • Behavioral: Relapse Prevention Plan
  • Behavioral: Daily Support Website
  • Behavioral: Computer CBT for voices and paranoia
  • Behavioral: FOCUS
  • Other: Prescriber Decision Assistant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 2, 2015)
461
Original Estimated Enrollment  ICMJE
 (submitted: February 10, 2015)
770
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02364544
Other Study ID Numbers  ICMJE ICRC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party John Kane, Northwell Health
Study Sponsor  ICMJE Northwell Health
Collaborators  ICMJE
  • University of Pittsburgh
  • Boston University
  • Dartmouth-Hitchcock Medical Center
Investigators  ICMJE
Principal Investigator: John Kane Northwell Health
PRS Account Northwell Health
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP