Adapting Critical Time Intervention to Support Inpatient Medical Care Transition
Phase: NA
Conditions: Schizophrenia, Medical Complication
Sponsor: New York State Psychiatric Institute

Protocol Summary Form
7657
Smith, Thomas
Page 1 of 13
Protocol Title:
Adapting Critical Time Intervention to 
Support Inpatient Medical Care Transition
Protocol Number:
7657
First Approval:
07/11/2018
Expiration Date:
06/17/2020
Version Date:
06/20/2019
Contact Principal Investigator:
Thomas Smith, MD
Email: thomas.smith@nyspi.columbia.edu
Telephone: 646-774-8442
Co-Investigator(s):
Mark Olfson, MD
Scott Stroup, MD, MPH
Leslie Marino, MD, MPH
Research Chief:
Lisa Dixon, MD, MPH
Cover Sheet
Choose ONE option from the following that is applicable to your study
If you are creating a new protocol, select "I am submitting a new protocol." As 5 Year Renewals are no 
longer required, this option remains for historical purposes.
I am submitting an annual continuation with modifications
Division & Personnel
Division
What Division/Department does the PI belong to?
Behavioral Health Services and Policy Research
Within the division/department, what Center or group are you affiliated with, if any? 
N/A
Unaffiliated Personnel
List investigators, if any, who will be participating in this protocol but are not affiliated with New York 

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State Psychiatric Institute or Columbia University. Provide: Full Name, Degrees and Affiliation.
Susan Beane, MD - Site PI
Ian Shaffer, MD
HealthFirst
 
Ketki Shah, MD - Site PI
Andreas Evdokas, MD
BronxCare Health System
 
Mary-Alice Dowd, MD - Site PI
Henry Chung, MD
Montefiore Medical Center
Daniel Herman, MSW, PhD - Co-I
Hunter College, City University of New York 
 
Leo Cabassa, MD - Co-I
University of Washington 
Amendment
Describe the change(s) being made 
1. We are adding an additional field to the permission to contact form 
 
2. We are submitting the data sharing document for IRB approval to share with NDS at NIMH 
Provide the rationale for the change(s) 
1. We need to collect the Medicaid ID number to link with HealthFirst data.  
 
2. Required by NIMH as part of this study 
Comment on the extent to which the proposed change(s) alter or affect risks/benefits to subjects 
1. None       
 
2. None 
 
Comment on if the proposed change(s) require a modification to the Consent Form (CF)

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1. None 
 
2. This process is already described in detail in the consent forms. 
 
Application for Continuation of Research
Status
Current Status of Study: 
Subject enrollment is ongoing.
Summary of Experiences to Date
Please provide a summary of scientific progress of the study and the experience of research participants, to 
date. This requirement is designed to allow for the investigator and the IRB to reassess the study’s risks and 
benefits in terms of developments in the field, changing practice patterns, and new IRB policies and 
procedures.
The study was delayed 3 months in beginning recruitment due to logistical issues with partners. We have 
recently begun enrollment and are still on target to reach our goals. We have enrolled 3 subjects so far with 
no issues. 
Funding
Have there been any changes in funding status since the prior approval? 
No
Have the principal investigator and other investigators made all required disclosures of financial interest in 
the study sponsor/product?
Yes
Summary
Have there been any study findings, recent literature, or untoward events occuring here or at other sites in 
the past year which might affect the analysis of the safety, risks or benefits of study participation? 
No
Have there been any serious adverse events (serious and/or unanticipated problems involving risks to 
subjects or others at this site which occured in the past year)? 
No
Have all study staff with a significant role in the design or implementation of the human subject components 
of this study received required training in human research subject protections?
Yes
Is the study covered by a certificate of confidentiality? 
Yes

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Certificate expiration date (mm/dd/yyyy) 
04/30/2020
Overall Progress
Approved sample size
60
Total number of participants enrolled to date
3
Number of participants who have completed the study to date 
0
Have there been any significant deviations from the anticipated study recruitment, retention or completion 
estimates? 
No
Comments / additional information 
We did not ultimately recruit any patients for the qualitative study as we were able to get enough 
information to adapt the model using other, non-research stakeholders. 
Sample Demographics
Specify population
CTI feasability pilot
Total number of participants enrolled from this population to date 
3
Gender, Racial and Ethnic Breakdown 
Male: 3/3, 100%
Black: 2/3, 67%
Hispanic: 1/3, 33% 
Summary of Current Year's Enrollment and Drop-out 
Number of participants who signed consent in the past year
3
Number of participants currently enrolled
3
Did the investigator withdraw participants from the study? 
No
Did participants decide to discontinue study involvement? 
No

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Procedures
To create the protocol summary form, first indicate if this research will include any of the following 
procedures
   Psychiatric Assessment
   Audio or Videotaping
Population
Indicate which of the following populations will be included in this research
   Medically Ill Subjects
   Adults
   Individuals with Psychosis
   Inpatients
Research Support/Funding
Will an existing internal account be used to support the project?
No
Is the project externally funded or is external funding planned?
Yes
Select the number of external sources of funding that will be applicable to this study
Funding Source #1
Is the PI of the grant/contract the same as the PI of the IRB protocol? 
No
Who is the PI of the grant/contract?
Stroup, Scott, MD
Select one of the following
The grant/contract is currently funded
Source of Funding
Federal
Institute/Agency
NIMH
Grant Name
Optimizing and Personalizing Interventions for Schizophrenia Across the Lifespan
Grant Number
1 P50 MH 115843 – 01
Select one of the following
Multicenter(NYSPI is the lead site)
Business Office

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RFMH
Does the grant/contract involve a subcontract? 
Yes
Subcontracted?
To
Name institution(s)
City University of New York at Hunter College
 
Healthfirst Management Services LLC
 
Columbia University 
Study Location
Indicate if the research is/will be conducted at any of the following
   NYSPI
This protocol describes research conducted by the PI at other facilities/locations
Yes
   Hospital, clinics and other healthcare facilities
Hospitals,clinics and other healthcare facilities 
Select from the list
or type in location(s).. 
BronxCare Health System
 
Montefiore Medical Center 
 
Some research assessments may be conducted in the community 
Uploaded Protocol Summary Form
Upload Document
Select file to upload.
Word PSF_v4.pdf

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Lay Summary of Proposed Research 
Lay Summary of Proposed Research
Critical Time Intervention (CTI) is a promising evidence-based time-limited intervention that mobilizes 
support for highly vulnerable individuals during transition periods, for example following discharge from a 
hospital inpatient unit. CTI facilitates community integration and continuity of care by helping patients 
develop enduring connections to their community and support systems during periods of transition. Our 
adaptation of the CTI model is a time-limited (3 month) targeted service coordination intervention and is 
delivered in two phases: 1) Bridging the transition to outpatient care, and 2) Facilitating ongoing 
engagement in community-based services. In the first phase, the CTI care manager maintains a high level of 
contact with both the participant and those involved in providing and supporting his/her treatment (doctor, 
therapist, family, etc). The care manager initially meets with the participant prior to discharge from the 
hospital, building rapport and appraising needs. After discharge the care manager maintains regular phone 
and in-person contact with the participant, visits him/her in his/her residence, continues assessment and care 
plan development, coordinates care with identified providers, and meets with people who support their 
treatment and well-being. In the second phase, the care manager continues assessment of the participant’s 
treatment and service needs and ongoing collaboration with the participant to fine tune the various supports 
and treatments identified and implemented in the first phase. Priority is placed on strengthening their skills 
and sense of autonomy in managing service engagement and use. During each phase, CTI considers 7 target 
areas that are important to individual well-being, medical and psychiatric stability and treatment linkages: 
(a) Systems Engagement and Coordination; (b)Sus taining Motivation in Substance Abuse Treatment; (c) 
Medication Adherence; (d) Family Involvement/Social Network Support; (e) Housing and Income; (f) 
Integration of Medical Care; and (g) Practical Needs Assistance. 
This pilot study will assess the feasibility and preliminary effectiveness of adapting CTI for adults with 
schizophrenia who have been medically admitted for the inpatient treatment of ambulatory care sensitive 
conditions (ACSCs) which are common health conditions, such as chronic obstructive pulmonary disease or 
short-term complications from diabetes mellitus, in which appropriate outpatient care should prevent or 
reduce the need for inpatient treatment. We will conduct the study at two large hospital centers in the Bronx 
(Montefiore Medical Center and BronxCare Health System and collaborate with Healthfirst, a NYC 
Medicaid Managed Care, to identify patients who are admitted to either of these hospitals and who meet 
study criteria. In the first phase we will conduct a qualitative study with eight hospital staff stakeholders and 
two patients with schizophrenia to help inform the adaptation of CTI to this population and intervention. We 
will then conduct a 2-arm pilot study which will randomize 60 eligible inpatients to receive either: 1) 
treatment as usual (TAU) (N=20); or 2) CTI and TAU (N=40). The primary outcome measure will be 
all-cause hospital readmissions at 7 and 30 days following discharge. Secondary outcomes will include 
follow-up with medical and mental health at 7 and 30 days following hospital discharge. All consented 
subjects will receive 6 and 12-week assessments to evaluate secondary outcomes including satisfaction 
with CTI services (only those in CTI group), psychiatric symptoms, community function, and 
involvement in medical care decisions.

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Description of Subject Population
Sample #1
Specify subject population
CTI Feasibility pilot
Number of completers required to accomplish study aims
60
Projected number of subjects who will be enrolled to obtain required number of completers
75
Age range of subject population
21-64
Sample #2
Specify subject population
CTI Stakeholder interviews - Patients
Number of completers required to accomplish study aims
2
Projected number of subjects who will be enrolled to obtain required number of completers
2
Age range of subject population
21-64
Gender, Racial and Ethnic Breakdown
We expect that the gender, racial and ethnic breakdown for the patient samples (1, 2) will match the 
characteristics of individuals admitted to the hospitals meeting eligibility criteria as shown below. 
 
Characteristics of admissions between Jan 2015 – June 2016 ACSC and Schizophrenia 
Age, years, mean (SD) 50.8 (10.8) 
Sex, % Male (54.0%) 
Race 
   White, non-Hispanic (11.3%) 
   Black, non-Hispanic (47.2%) 
   Hispanic (32.4%) 
    
 
Description of subject population
Sample 1: CTI Feasibility Pilot (N=60)

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Newly admitted Healthfirst BCHS and MMC inpatients ages 21 to 64 years with ≥2 outpatient and ≥1 
inpatient claims for schizophrenia during the past 12 months and an admitting ACSC diagnosis  will be 
eligible to participate in the study. 
 
Sample 2: Patient Stakeholder interviews (N=2)
Patient with a diagnosis of schizophrenia and co-morbid medical illness who are either admitted to the 
inpatient medical service, or who attend one of the outpatient psychiatry clinics at the participating 
hospitals 
 
 
Recruitment Procedures
Describe settings where recruitment will occur
Recruitment will occur at each of the participating hospital sites.
How and by whom will subjects be approached and/or recruited? 
CTI Patient Stakeholder Interviews
Patients eligible for qualitative interviews will be identified and informed of the study by hospital clinical 
staff familiar with the study’s target population (patients with schizophrenia who have co-occurring medical 
conditions) and who have been admitted to the medical inpatient unit or attend the psychiatry outpatient 
clinic. Patients who are identified by hospital staff will sign a permission to be contacted form that will be 
faxed to the PI by hospital staff upon completion. Once identified, the study PI (Tom Smith), Co-PI (Leslie 
Marino), or RA (TBD) will contact the stakeholder to discuss the study and schedule a time to complete the 
interview.
 
CTI Feasibility Pilot Study
Healthfirst data system algorithms will identify patients eligible for the study. Healthfirst care managers will 
then contact the potential subject’s treatment team to review the patient's appropriateness for research and if 
the team and if the team agrees the patient is appropriate, the care manager and treatment team will 
determine the most appropriate way to introduce the patient to the study. The care manager and/or clinical 
team will share the information sheet with the patient and ask the patient to sign a permission to contact 
form if they agree to be contacted by the research team to participate. This form will be faxed directly to the 
PI, at which time the research assistant will be sent to the hospital to discuss the study procedures and obtain 
consent. 
 
How will the study be advertised/publicized? 
Neither phase of the study will be advertised. 
Do you have ads/recruitment material requiring review at this time? 
Yes
Does this study involve a clinical trial?
Yes

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Please provide the NCT Registration Number
NCT03637296
Concurrent Research Studies
Will subjects in this study participate in or be recruited from other studies? 
No
Waiver of Consent/Authorization
Indicate if you are requesting any of the following consent waivers
Waiver of consent for use of records that include protected health information (a HIPAA waiver of 
Authorization) 
No
Waiver or alteration of consent
No
Waiver of documentation of consent 
No
Waiver of parental consent 
No
Consent Procedures
Is eligibility screening for this study conducted under a different IRB protocol?
No
Describe procedures used to obtain consent during the screening process 
CTI Patient Stakeholder Interviews
Once potential patient stakeholders have been identified by hospital staff, they will provide written 
permission to by contacted by research staff to complete the interviews. Research staff (either trained RA, or 
Dr. Marino) will speak with the patient by phone to arrange a time that is convenient for them to complete 
the interview. 
 
CTI Feasibility Pilot Study 
Prior to approaching prospective study participants, research staff or the Healthfirst care manager will ask a 
member of the clinical team whether the patient is a good candidate for the study and able to understand 
study procedures. We will not approach the patient if the treatment team does not feel that the patient would 
be appropriate for research. We will determine with the primary team the most appropriate way to contact 
the patient and discuss study participation. The individual who initially meets with the patient will introduce 
the study with an information sheet and ask for the patient's permission to invite a research assistant to 
discuss the study and consent process. Patient's documented permission and contact info will be faxed to the 

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study PI who will notify the research assistant. The research assistant will then go to the hospital and 
consent the patient. The CTI team will meet the patient 24 hours prior to discharge.
 
Describe Study Consent Procedures
CTI Patient Stakeholder Interviews
The interview will be conducted on-site at the hospital and consent will be reviewed and documented with 
the patient at that time. Consent will be obtained by either the trained RA, Dr. Smith or Dr. Marino. 
 
CTI Feasibility Pilot Study 
The trained bachelors level research assistant will approach the patient at the bedside in the hospital and will 
introduce themselves to the patient. They will ask the patient if this is a good time to discuss the study and 
with patient's permission, they will explain study procedures, risks, benefits, compensation, and 
confidentiality. They will ask the patient if they consent to participation and have patient sign consent 
document. 
 
 
Indicate which of the following are employed as a part of screening or main study consent procedures
   Consent Form
   Information Sheet
Persons designated to discuss and document consent
Select the names of persons designated to obtain consent/assent
Marino, Leslie, MD
Smith, Thomas, MD
Styke, Sarah
Type in the name(s) not found in the above list
Once patients are identified by Healthfirst staff, the project research assistant Sarah Styke will be 
dispatched to the hospital to obtain consent. 
 
For the stakeholder interviews, Dr. Marino and Dr. Smith may also obtain consent.  
Independent Assessment of Capacity
You have indicated that your study involves subjects who MAY LACK capacity to consent.
Does this study require an independent assessment of capacity?

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No
Methods to Protect Confidentiality
Will the study be conducted under a certificate of confidentiality?
Yes, we have already received a Certificate of Confidentiality
Compensation and/or Reimbursement 
Will compensation or reimbursement for expenses be offered to subjects?
Yes
Please describe and indicate total amount and schedule of payment(s). 
Include justification for compensation amounts and indicate if there are bonus payments.
Participants enrolled in the CTI feasibility pilot study will receive $40 for each completed assessment 
(baseline, 6 weeks and 12 weeks post-discharge) for a potential total amount compensation equal to $120. 
They will receive the compensation in the form of a cash card at the time of the assessment, after it is 
completed. 
Patients enrolled in the stakeholder interviews will received $25 for their time participating in the qualitative 
interview. will receive the compensation in the form of a cash card at the time of the interview, after it is 
completed. 
 
Participant compensation represents support for their time and effort involved in participating in these 
research activities. 
Uploads
Upload the entire grant application(s)
OPAL FINAL RESEARCH PROPOSAL.pdf
Upload copy(ies) of unbolded Consent Form(s)
Consent_Form_CTI feasibility pilot_unbolded_BXCare_v2.pdf
Consent_Form_CTI feasibility pilot_unbolded_Monte_v2.pdf
Upload copy(ies) of bolded Consent Form(s)
Consent_Form_CTI feasibility pilot_bolded_BXCare_v2.pdf
Consent_Form_CTI feasibility pilot_bolded_Monte_v2.pdf
Upload copy(ies) of unbolded Information Sheet(s)
Information sheet_v2.pdf
Upload copy(ies) of bolded Information Sheet(s)
Upload copy(ies) of recruitment materials/ads to be reviewed

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Permission for contact_v3.pdf
Upload a copy of Certificate of Confidentiality
Upload copy(ies) of the HIPAA form
HIPAA (2).pdf
Upload any additional documents that may be related to this study
Data.RequestforUse_of_De-Identified_Data_Project2_5-8-19.pdf
IRB Response Memo 2019.06.06, 7657.CONT.appr_pend.en.060519 (3).pdf