Improving Care and Reducing Cost Study (ICRC)

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

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.

Condition or disease	Intervention/treatment	Phase
Schizophrenia; Schizoaffective Disorder; Psychosis NOS	Behavioral: Relapse Prevention Plan; Behavioral: Daily Support Website; Behavioral: Computer CBT for voices and paranoia; Behavioral: FOCUS; Other: Prescriber Decision Assistant	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 461 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Improving Care and Reducing Cost (ICRC) Program
• Study Start Date: April 2013
• Actual Primary Completion Date: June 2015
• Actual Study Completion Date: June 2015

Arms and Interventions

Arm

Intervention/treatment

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.

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Florida

Henderson Mental Health Center

Ft Lauderdale, Florida, United States, 33319

United States, Indiana

Community Mental Health Center, Inc.

Lawrenceburg, Indiana, United States, 47025

United States, Michigan

Cherry Street

Grand Rapids, Michigan, United States, 49503

United States, Missouri

UMKC School of Pharmacy

Kansas City, Missouri, United States, 64108

Burrell Behavioral Health

Springfield, Missouri, United States, 65802

United States, New Hampshire

The Mental Health Center of Greater Manchester

Manchester, New Hampshire, United States, 03101

United States, New Mexico

University of New Mexico Department of Psychiatry UNM Health Sciences Center

Albuquerque, New Mexico, United States, 87131

United States, Oregon

PeaceHealth Oregon/Lane County Behavioral Health Services

Eugene, Oregon, United States, 97401

Sponsors and Collaborators

Northwell Health

University of Pittsburgh

Boston University

Dartmouth-Hitchcock Medical Center

Investigators

• Principal Investigator: John Kane; Northwell Health

More Information

• Responsible Party: John Kane, Senior Vice President, Behavioral Health Services, Northwell Health
• ClinicalTrials.gov Identifier: NCT02364544
• Other Study ID Numbers: ICRC
• First Posted: February 18, 2015
• Last Update Posted: March 23, 2017
• Last Verified: March 2017

Additional relevant MeSH terms:

Schizophrenia; Psychotic Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders