SchizophreniaICRCNCT02364544
Improving Care and Reducing Cost Study
A study testing Relapse Prevention Plan, Daily Support Website and Computer CBT for voices and paranoia in people with Schizophrenia and Schizoaffective Disorder, run by Northwell Health at 8 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Psychosis NOS
- What is being tested?
- Relapse Prevention Plan, Daily Support Website and Computer CBT for voices and paranoia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 461 participants
- Where
- 8 sitesUnited States
- Study dates
- Apr 2013to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • 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
Show all 11Show fewer
- 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
Who cannot join
- • 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of New Mexico Department of Psychiatry UNM Health Sciences Center
Albuquerque, New Mexico, 87131
PeaceHealth Oregon/Lane County Behavioral Health Services
Eugene, Oregon, 97401
Henderson Mental Health Center
Fort Lauderdale, Florida, 33319
Cherry Street
Grand Rapids, Michigan, 49503
UMKC School of Pharmacy
Kansas City, Missouri, 64108
Community Mental Health Center, Inc.
Lawrenceburg, Indiana, 47025
The Mental Health Center of Greater Manchester
Manchester, New Hampshire, 03101
Burrell Behavioral Health
Springfield, Missouri, 65802
About this study
Official title: The Improving Care and Reducing Cost (ICRC) Program
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.
Read the 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.
- Conditions
- Schizophrenia, Schizoaffective Disorder, Psychosis NOS
- Being tested
- Relapse Prevention Plan, Daily Support Website, Computer CBT for voices and paranoia, FOCUS, Prescriber Decision Assistant
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relapse Prevention PlanBehavioural
brief, in-person, relapse prevention counseling with supplemental web-based learning modules,
Daily Support WebsiteBehavioural
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 paranoiaBehavioural
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
FOCUSBehavioural
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 AssistantOther
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 group | Role | What they receive |
|---|---|---|
| Health Technology Program | Other | 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. Receives: Behavioral: Relapse Prevention Plan; Behavioral: Daily Support Website; Behavioral: Computer CBT for voices and paranoia; Behavioral: FOCUS; Other: Prescriber Decision Assistant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Number of Hospitalization and Emergency Room Visits
Captures the number of hospital and ER visits each month
Measured: Baseline, Month 1, Month2, Month 3, Month4, Month 5, and Month 6
Secondary outcomes (2)
Service Utilization Resource Form
Captures services received in the last 30 days
Measured: Baseline, month 3, month 6
Change from Baseline Heinrich's Quality of Life Scale
Measured: Baseline and month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study startApr 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 461 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh, Boston University, Dartmouth-Hitchcock Medical Center
- Responsible party
- Principal investigator, John Kane, Northwell Health
- Investigators
- John Kane, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02364544
- Sponsor's protocol ID
- ICRC
- Acronym
- ICRC
- Status last verified
- Mar 2017
- First submitted
- 30 Jan 2015
- Last updated
- 23 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Improving Care and Reducing Cost (ICRC) Program
- ClinicalTrials.gov ID
- NCT02364544
- Acronym / sponsor ID
- ICRC / ICRC
- Conditions
- Schizophrenia, Schizoaffective Disorder, Psychosis NOS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 461 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- University of Pittsburgh, Boston University, Dartmouth-Hitchcock Medical Center
- Study start
- Apr 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 18 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health Technology Program | Other | Behavioral: Relapse Prevention Plan, Behavioral: Daily Support Website, Behavioral: Computer CBT for voices and paranoia, Behavioral: FOCUS, Other: Prescriber Decision AssistantThe 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- • Age 18 to 60, (patients age 51-60 require review from the coordinating site)
- 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
Key exclusion criteria (4 listed)
- • 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relapse Prevention Planbrief, in-person, relapse prevention counseling with supplemental web-based learning modules, | Behavioural | Health Technology Program |
| Daily Support Websiteweb-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 | Behavioural | Health Technology Program |
| Computer CBT for voices and paranoiaA 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 | Behavioural | Health Technology Program |
| FOCUSan interactive smart phone text-messaging application to support medication adherence, facilitate coping with symptoms and improve daily functioning in individuals with schizophrenia | Behavioural | Health Technology Program |
| Prescriber Decision Assistantis 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 | Other | Health Technology Program |
Primary outcome
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
2 secondary outcomes
Service Utilization Resource Form
Time frame: Baseline, month 3, month 6
Change from Baseline Heinrich's Quality of Life Scale
Time frame: Baseline and month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Kane principal investigator
Northwell Health
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relapse Prevention Plan, Daily Support Website and Computer CBT for voices and paranoia in people with Schizophrenia and Schizoaffective Disorder, run by Northwell Health at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Number of Hospitalization and Emergency Room Visits (time frame: Baseline, Month 1, Month2, Month 3, Month4, Month 5, and Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2017.