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Adapting Critical Time Intervention to Support Inpatient Medical Care Transition

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ClinicalTrials.gov Identifier: NCT03637296
Recruitment Status : Not yet recruiting
First Posted : August 17, 2018
Last Update Posted : August 17, 2018
Sponsor:
Collaborators:
Healthfirst
Montefiore Medical Center
Bronx-Lebanon Hospital Center Health Care System
Information provided by (Responsible Party):
Tom Smith, New York State Psychiatric Institute

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=40); 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.

Condition or disease Intervention/treatment Phase
Schizophrenia Ambulatory Care Sensitive Conditions Other: Critical time intervention Not Applicable

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=40); 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective cohort with comparison group
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adapting Critical Time Intervention to Support Inpatient Medical Care Transition
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Critical time intervention
Individuals who receive intensive care management during and following discharge from the inpatient medical unit.
Other: Critical time intervention
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.

No Intervention: Treatment as usual
Individuals who receive routine care management during and following discharge from the inpatient medical unit.



Primary Outcome Measures :
  1. 7- and 30-day hospital inpatient all-cause readmission rates [ Time Frame: Within 7 and 30 days following discharge ]
    Rates of readmission following discharge


Secondary Outcome Measures :
  1. Follow-up with outpatient medical and mental health services within 7 days and 30 days of hospital discharge [ Time Frame: Within 7 and 30 days after discharge ]
    Attendance at follow-up appointments



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03637296


Contacts
Contact: Thomas Smith, MD 646 774-8442 thomas.smith@nyspi.columbia.edu
Contact: Leslie Marino, MD 646 774-8442 leslie.marino@nyspi.columbia.edu

Sponsors and Collaborators
New York State Psychiatric Institute
Healthfirst
Montefiore Medical Center
Bronx-Lebanon Hospital Center Health Care System

Responsible Party: Tom Smith, Clinical Psychiatrist, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT03637296     History of Changes
Other Study ID Numbers: 7657
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: 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.
URL: http://

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders