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Adapting Critical Time Intervention to Support Inpatient Medical Care Transition

Primary Purpose

Schizophrenia, Medical Complication

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Critical time intervention
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

21 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 21 to 64 years old
  • Diagnosis of schizophrenia
  • Admitted to medical unit at collaborating hospital
  • Admission diagnosis of Ambulatory Care Sensitive Condition

Exclusion Criteria:

  • Not enrolled in Healthfirst Medicaid Managed Care plan for 12 months prior to admission

Sites / Locations

  • Bronx Care Health System
  • Montefiore Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Critical time intervention

Treatment as usual

Arm Description

Individuals who receive intensive care management during and following discharge from the inpatient medical unit.

Individuals who receive routine care management during and following discharge from the inpatient medical unit.

Outcomes

Primary Outcome Measures

7 Days Hospital Inpatient All-cause Readmission Rates
Rates of hospital inpatient readmission within 7 days following discharge
30 Days Hospital Inpatient All-cause Readmission Rates
Rates of hospital inpatient readmission within 30 days following discharge

Secondary Outcome Measures

Number of Participants Who Follow up With Outpatient Medical Within 7 Days of Hospital Discharge
Number of Participants who follow-up with outpatient medical attendance within 7 days of hospital discharge at follow-up appointments
Number of Participants Who Follow-up With Outpatient Medical Within 30 Days of Hospital Discharge
Number of Participants who follow-up with outpatient medical attendance within 30 days of hospital discharge at follow-up appointments
Number of Participants Who Follow-up With Outpatient Mental Health Services Within 7 Days of Hospital Discharge
Number of Participants who follow-up with Outpatient Mental Health Services attendance within 7 days of hospital discharge at follow-up appointments
Number of Participants Who Follow-up With Outpatient Mental Health Services Within 30 Days of Hospital Discharge
Number of Participants who follow-up with Outpatient Mental Health Services attendance within 30 days of hospital discharge at follow-up appointments

Full Information

First Posted
August 14, 2018
Last Updated
September 26, 2021
Sponsor
New York State Psychiatric Institute
Collaborators
Healthfirst, Montefiore Medical Center, Bronx-Lebanon Hospital Center Health Care System
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1. Study Identification

Unique Protocol Identification Number
NCT03637296
Brief Title
Adapting Critical Time Intervention to Support Inpatient Medical Care Transition
Official Title
Adapting Critical Time Intervention to Support Inpatient Medical Care Transition
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
This study is terminated due to COVID-19 pandemic
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
Healthfirst, Montefiore Medical Center, Bronx-Lebanon Hospital Center Health Care System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
We are pursuing a pilot study to assess the feasibility and preliminary effectiveness of adapting a critical time intervention (CTI) approach for adults with schizophrenia who have been admitted for the inpatient treatment of ambulatory care sensitive conditions. These are common health conditions, such as chronic obstructive pulmonary disease or short-term complications from diabetes mellitus, in which appropriate ambulatory care prevents or reduces the need for inpatient treatment. A 2-arm pilot study will randomize 80 eligible inpatients to receive either: 1) treatment as usual (TAU) (N=20); or 2) CTI and TAU (N=40). Participants assigned to CTI will meet with a CTI care manger during their inpatient stay and over a 3-month period following hospital discharge. CTI care managers will assess and address patient needs and barriers to outpatient medical and mental health care and provide support and assistance with health and mental health care management. 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. Patients receiving CTI will also receive 6 and 12 week assessments to evaluate secondary outcomes including satisfaction with CTI services, psychiatric symptoms, community function, and involvement in medical care decisions.
Detailed Description
For adults with schizophrenia, the transition from hospital inpatient to outpatient care poses substantial risks of treatment disengagement. Traditional case management approaches for patients with schizophrenia have involved telephonic follow-up after discharge from inpatient mental health care and have yielded poor results. Much less information exists regarding outcomes for patients with schizophrenia discharged following inpatient medical care. Given that these patients often have difficulty accessing and adhering to medical treatments, patients with schizophrenia who are admitted to a hospital for treatment of a medical condition are especially vulnerable to failed care transitions. Intensive interventions involving home visits, social support, motivational interviewing, and accompanying patients to outpatient appointments have shown positive results for patients discharged following inpatient mental health care, and may therefore be effective for patients with schizophrenia discharged following inpatient medical care. Critical Time Intervention (CTI) is a novel evidence based time-limited intervention that involves ongoing community-based contacts with patients from trained care managers to facilitate connections to aftercare providers and community and support systems following hospital discharge. This pilot study will adapt CTI for use with patients with schizophrenia who are admitted to one of 2 safety net hospitals in Bronx, New York, for treatment of ambulatory care sensitive conditions (medical conditions for which appropriate ambulatory care should limit the need for inpatient treatment). We will randomize 80 eligible inpatients to receive either: 1) treatment as usual (TAU) (n=20); or 2) CTI and TAU (n=40). During a 3-month period prior to randomization, an Adaptation Team of research and hospital staff will review data from qualitative interviews of clinical staff and patients to identify factors likely to facilitate and impede CTI implementation. The team will then adapt the CTI to increase the likelihood of successful implementation. In the randomization phase, participants assigned to CTI will meet with a CTI care manger during their inpatient stay and over a 3-month period following hospital discharge. CTI care managers will assess and address patient needs and barriers to outpatient medical and mental health care and provide support and assistance with medical and mental health care management. For quantitative analyses, the primary outcome measures will be all-cause hospital readmissions at 7 and 30 days following discharge. Secondary outcomes will include follow-up with medical and mental health outpatient care at 7 and 30 days following hospital discharge. Patients receiving CTI will also be assessed to evaluate satisfaction with CTI services, psychiatric symptoms, community function, and involvement in medical care decisions. The proposed study will test whether a time-limited novel intervention helps overcome common barriers to adherence with outpatient medical and mental health care and reduces hospital readmissions for a vulnerable population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Medical Complication

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective cohort with comparison group
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Critical time intervention
Arm Type
Experimental
Arm Description
Individuals who receive intensive care management during and following discharge from the inpatient medical unit.
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
Individuals who receive routine care management during and following discharge from the inpatient medical unit.
Intervention Type
Other
Intervention Name(s)
Critical time intervention
Intervention Description
Care management offered by individual with experience working with individuals with serious mental illness. The care managers engage individuals before they are discharged from the hospital and work with them in the community to support linkages with medical and behavioral health care providers. Care managers provide problem-solving, advice, and support to maximize patients' engagement in care.
Primary Outcome Measure Information:
Title
7 Days Hospital Inpatient All-cause Readmission Rates
Description
Rates of hospital inpatient readmission within 7 days following discharge
Time Frame
Within 7 days following discharge
Title
30 Days Hospital Inpatient All-cause Readmission Rates
Description
Rates of hospital inpatient readmission within 30 days following discharge
Time Frame
Within 30 days following discharge
Secondary Outcome Measure Information:
Title
Number of Participants Who Follow up With Outpatient Medical Within 7 Days of Hospital Discharge
Description
Number of Participants who follow-up with outpatient medical attendance within 7 days of hospital discharge at follow-up appointments
Time Frame
Within 7 days after discharge
Title
Number of Participants Who Follow-up With Outpatient Medical Within 30 Days of Hospital Discharge
Description
Number of Participants who follow-up with outpatient medical attendance within 30 days of hospital discharge at follow-up appointments
Time Frame
Within 30 days after discharge
Title
Number of Participants Who Follow-up With Outpatient Mental Health Services Within 7 Days of Hospital Discharge
Description
Number of Participants who follow-up with Outpatient Mental Health Services attendance within 7 days of hospital discharge at follow-up appointments
Time Frame
Within 7 days after discharge
Title
Number of Participants Who Follow-up With Outpatient Mental Health Services Within 30 Days of Hospital Discharge
Description
Number of Participants who follow-up with Outpatient Mental Health Services attendance within 30 days of hospital discharge at follow-up appointments
Time Frame
Within 30 days after discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 21 to 64 years old Diagnosis of schizophrenia Admitted to medical unit at collaborating hospital Admission diagnosis of Ambulatory Care Sensitive Condition Exclusion Criteria: Not enrolled in Healthfirst Medicaid Managed Care plan for 12 months prior to admission
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Smith, MD
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bronx Care Health System
City
Bronx
State/Province
New York
ZIP/Postal Code
10457
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Raw data will be made available for research to investigators working under a Federal Wide Assurance who meet security measures and data use agreement criteria associated with public repositories including the National Database for Clinical Trials related to Mental Illness (NDCT). Data will include baseline demographic data, and baseline and post raw data derived from functioning and symptom measures.
IPD Sharing Time Frame
A list of all data expected to be collected in the project will be submitted within 6 months of award. Subsequently, descriptive and raw data will be submitted on a semi-annual basis. Unpublished de-identified data will be submitted prior to study completion and will be shared within one year after project completion, or when the data are published, whichever is earlier.
IPD Sharing Access Criteria
Data in NIH repositories may be accessed through the NIH Data Access Committee which reviews data access and submission requests.

Learn more about this trial

Adapting Critical Time Intervention to Support Inpatient Medical Care Transition

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