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Adapting Critical Time Intervention to Support Inpatient Medical Care Transition

Adapting Critical Time Intervention to Support Inpatient Medical Care Transition

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03637296
Enrollment
15
Registered
2018-08-17
Start date
2019-05-01
Completion date
2020-12-31
Last updated
2021-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia, Medical Complication

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.

Interventions

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.

Sponsors

Healthfirst
CollaboratorOTHER
Montefiore Medical Center
CollaboratorOTHER
Bronx-Lebanon Hospital Center Health Care System
CollaboratorOTHER
New York State Psychiatric Institute
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Prospective cohort with comparison group

Eligibility

Sex/Gender
ALL
Age
21 Years to 64 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
7 Days Hospital Inpatient All-cause Readmission RatesWithin 7 days following dischargeRates of hospital inpatient readmission within 7 days following discharge
30 Days Hospital Inpatient All-cause Readmission RatesWithin 30 days following dischargeRates of hospital inpatient readmission within 30 days following discharge

Secondary

MeasureTime frameDescription
Number of Participants Who Follow up With Outpatient Medical Within 7 Days of Hospital DischargeWithin 7 days after dischargeNumber 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 DischargeWithin 30 days after dischargeNumber 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 DischargeWithin 7 days after dischargeNumber 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 DischargeWithin 30 days after dischargeNumber of Participants who follow-up with Outpatient Mental Health Services attendance within 30 days of hospital discharge at follow-up appointments

Countries

United States

Participant flow

Participants by arm

ArmCount
Critical Time Intervention
Individuals who receive intensive care management during and following discharge from the inpatient medical unit. 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.
10
Treatment as Usual
Individuals who receive routine care management during and following discharge from the inpatient medical unit.
5
Total15

Baseline characteristics

CharacteristicCritical Time InterventionTotalTreatment as Usual
Age, Continuous51.3 years
STANDARD_DEVIATION 9.4
49.4 years
STANDARD_DEVIATION 8.6
45.5 years
STANDARD_DEVIATION 5.8
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants6 Participants3 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
7 Participants9 Participants2 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
8 Participants12 Participants4 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
2 Participants3 Participants1 Participants
Region of Enrollment
United States
10 participants15 participants5 participants
Sex: Female, Male
Female
8 Participants9 Participants1 Participants
Sex: Female, Male
Male
2 Participants6 Participants4 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 100 / 5
other
Total, other adverse events
0 / 100 / 5
serious
Total, serious adverse events
0 / 100 / 5

Outcome results

Primary

30 Days Hospital Inpatient All-cause Readmission Rates

Rates of hospital inpatient readmission within 30 days following discharge

Time frame: Within 30 days following discharge

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Critical Time Intervention30 Days Hospital Inpatient All-cause Readmission Rates7 Participants
Treatment as Usual30 Days Hospital Inpatient All-cause Readmission Rates0 Participants
Primary

7 Days Hospital Inpatient All-cause Readmission Rates

Rates of hospital inpatient readmission within 7 days following discharge

Time frame: Within 7 days following discharge

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Critical Time Intervention7 Days Hospital Inpatient All-cause Readmission Rates3 Participants
Treatment as Usual7 Days Hospital Inpatient All-cause Readmission Rates0 Participants
Secondary

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

Time frame: Within 30 days after discharge

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Critical Time InterventionNumber of Participants Who Follow-up With Outpatient Medical Within 30 Days of Hospital Discharge9 Participants
Treatment as UsualNumber of Participants Who Follow-up With Outpatient Medical Within 30 Days of Hospital Discharge4 Participants
Secondary

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

Time frame: Within 7 days after discharge

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Critical Time InterventionNumber of Participants Who Follow up With Outpatient Medical Within 7 Days of Hospital Discharge7 Participants
Treatment as UsualNumber of Participants Who Follow up With Outpatient Medical Within 7 Days of Hospital Discharge4 Participants
Secondary

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

Time frame: Within 30 days after discharge

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Critical Time InterventionNumber of Participants Who Follow-up With Outpatient Mental Health Services Within 30 Days of Hospital Discharge4 Participants
Treatment as UsualNumber of Participants Who Follow-up With Outpatient Mental Health Services Within 30 Days of Hospital Discharge1 Participants
Secondary

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

Time frame: Within 7 days after discharge

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Critical Time InterventionNumber of Participants Who Follow-up With Outpatient Mental Health Services Within 7 Days of Hospital Discharge1 Participants
Treatment as UsualNumber of Participants Who Follow-up With Outpatient Mental Health Services Within 7 Days of Hospital Discharge0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026