Improving Care and Reducing Cost Study

Schizophrenia Clinical Trial

— ICRC  

Official title:

The Improving Care and Reducing Cost (ICRC) Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02364544
• Other study ID #: ICRC
• Status: Completed
• Phase: N/A
• First received: January 30, 2015
• Last updated: March 22, 2017
• Start date: April 2013
• Est. completion date: June 2015

Study information

• Verified date: March 2017
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 461
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis NOS
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Behavioral:
• Relapse Prevention Plan
brief, in-person, relapse prevention counseling with supplemental web-based learning modules,
• 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
• 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
• 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

Locations

Country	Name	City	State
United States	University of New Mexico Department of Psychiatry UNM Health Sciences Center	Albuquerque	New Mexico
United States	PeaceHealth Oregon/Lane County Behavioral Health Services	Eugene	Oregon
United States	Henderson Mental Health Center	Ft Lauderdale	Florida
United States	Cherry Street	Grand Rapids	Michigan
United States	UMKC School of Pharmacy	Kansas City	Missouri
United States	Community Mental Health Center, Inc.	Lawrenceburg	Indiana
United States	The Mental Health Center of Greater Manchester	Manchester	New Hampshire
United States	Burrell Behavioral Health	Springfield	Missouri

Sponsors (4)

Lead Sponsor	Collaborator
Northwell Health	Boston University, Dartmouth-Hitchcock Medical Center, University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Service Utilization Resource Form	Captures services received in the last 30 days	Baseline, month 3, month 6
Secondary	Change from Baseline Heinrich's Quality of Life Scale		Baseline and month 6