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SchizophreniaNCT03637296

Adapting Critical Time Intervention to Support Inpatient Medical Care Transition

A study testing Critical time intervention in people with Schizophrenia and Medical Complication, run by New York State Psychiatric Institute at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 64 years
Conditions the study is for
Schizophrenia, Medical Complication
What is being tested?
Critical time intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
2 sitesUnited States
Study dates
1 May 2019to 31 Dec 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 21 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Bronx Care Health System

    The Bronx, New York, 10457

  • Montefiore Medical Center

    The Bronx, New York, 10467

Other trials in United States

About this study

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.

Read the 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.

Being tested
Critical time intervention
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Critical time interventionOther

    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.

Study groups in NCT03637296
Study groupRoleWhat they receive
Critical time interventionExperimentalIndividuals who receive intensive care management during and following discharge from the inpatient medical unit.
Receives: Other: Critical time intervention
Treatment as usualNo interventionIndividuals who receive routine care management during and following discharge from the inpatient medical unit.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 7 Days Hospital Inpatient All-cause Readmission Rates

    Rates of hospital inpatient readmission within 7 days following discharge

    Measured: Within 7 days following discharge

  2. 30 Days Hospital Inpatient All-cause Readmission Rates

    Rates of hospital inpatient readmission within 30 days following discharge

    Measured: Within 30 days following discharge

Secondary outcomes (4)
  1. 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

    Measured: Within 7 days after discharge

  2. 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

    Measured: Within 30 days after discharge

  3. 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

    Measured: Within 7 days after discharge

  4. 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

    Measured: Within 30 days after discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2018
  2. Study start1 May 2019
  3. Primary completion31 Dec 2020
  4. Study completion31 Dec 2020

Why it stopped: This study is terminated due to COVID-19 pandemic

Resources

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
Non-randomised
Intervention model
Parallel groups
Model description
Prospective cohort with comparison group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03637296
Sponsor's protocol ID
7657
Status last verified
Sep 2021
First submitted
14 Aug 2018
Last updated
28 Sep 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Critical time intervention in people with Schizophrenia and Medical Complication, run by New York State Psychiatric Institute at 2 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 4 inclusion and 1 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: stopped early, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

Yes. Results are posted in the registry (first posted 28 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

7 Days Hospital Inpatient All-cause Readmission Rates (time frame: Within 7 days following discharge). The study lists 2 primary outcomes in all. 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 28 Sep 2021.

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