Clinical trial NCT02364544: Improving Care and Reducing Cost Study
Official title: The Improving Care and Reducing Cost (ICRC) Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Psychosis NOS
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
name: Boston University
name: Dartmouth-Hitchcock Medical Center
First posted: 2015-02-18
Enrollment: 461
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Total Number of Hospitalization and Emergency Room Visits
timeFrame: Baseline, Month 1, Month2, Month 3, Month4, Month 5, and Month 6
Secondary outcomes:
measure: Service Utilization Resource Form
timeFrame: Baseline, month 3, month 6
measure: Change from Baseline Heinrich's Quality of Life Scale
timeFrame: Baseline and month 6
Other outcomes:
Locations:
city: Ft Lauderdale
country: United States
facility: Henderson Mental Health Center
state: Florida
city: Lawrenceburg
country: United States
facility: Community Mental Health Center, Inc.
state: Indiana
city: Grand Rapids
country: United States
facility: Cherry Street
state: Michigan
city: Kansas City
country: United States
facility: UMKC School of Pharmacy
state: Missouri
city: Springfield
country: United States
facility: Burrell Behavioral Health
state: Missouri
city: Manchester
country: United States
facility: The Mental Health Center of Greater Manchester
state: New Hampshire
city: Albuquerque
country: United States
facility: University of New Mexico Department of Psychiatry UNM Health Sciences Center
state: New Mexico
city: Eugene
country: United States
facility: PeaceHealth Oregon/Lane County Behavioral Health Services
state: Oregon
Study officials:
affiliation: Northwell Health
name: John Kane
role: PRINCIPAL_INVESTIGATOR
References: