Adapting Critical Time Intervention to Support Inpatient Medical Care Transition

NCT03637296 | Terminated Results

• 1 other identifier: 7657
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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.

Conditions

Schizophrenia; Medical Complication

Outcome Measures

Primary Outcomes (2)

• 7 Days Hospital Inpatient All-cause Readmission Rates

  Rates of hospital inpatient readmission within 7 days following discharge

  Within 7 days following discharge

• 30 Days Hospital Inpatient All-cause Readmission Rates

  Rates of hospital inpatient readmission within 30 days following discharge

  Within 30 days following discharge

Secondary Outcomes (4)

• Number of Participants Who Follow up With Outpatient Medical Within 7 Days of Hospital Discharge

  Within 7 days after discharge

• Number of Participants Who Follow-up With Outpatient Medical Within 30 Days of Hospital Discharge

  Within 30 days after discharge

• Number of Participants Who Follow-up With Outpatient Mental Health Services Within 7 Days of Hospital Discharge

  Within 7 days after discharge

• Number of Participants Who Follow-up With Outpatient Mental Health Services Within 30 Days of Hospital Discharge

  Within 30 days after discharge

Study Arms (2)

Critical time intervention

EXPERIMENTAL

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

Other: Critical time intervention

Treatment as usual

NO INTERVENTION

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

Interventions

Critical time intervention OTHER

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.

Critical time intervention

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• Healthfirst: collaborator
• Montefiore Medical Center: collaborator
• Bronx-Lebanon Hospital Center Health Care System: collaborator

Study Sites (2)

Bronx Care Health System

The Bronx, New York, 10457, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Thomas Smith, MD
• Organization: New York State Psychiatric Institute

thomas.smith@nyspi.columbia.edu

(646)774-8442

Study Officials

• Thomas Smith, MD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychiatrist

Model Details: Prospective cohort with comparison group

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 17, 2018
• Study Start: May 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: September 28, 2021
• Results First Posted: September 28, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.
• Access Criteria: Data in NIH repositories may be accessed through the NIH Data Access Committee which reviews data access and submission requests.

Locations

US (2)