Clinical trial NCT03637296: 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
Overall status: TERMINATED
Phase: NA
Conditions: Schizophrenia
Medical Complication
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: Healthfirst
name: Montefiore Medical Center
name: Bronx-Lebanon Hospital Center Health Care System
First posted: 2018-08-17
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective cohort with comparison group
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 7 Days Hospital Inpatient All-cause Readmission Rates
timeFrame: Within 7 days following discharge
measure: 30 Days Hospital Inpatient All-cause Readmission Rates
timeFrame: Within 30 days following discharge
Secondary outcomes:
measure: Number of Participants Who Follow up With Outpatient Medical Within 7 Days of Hospital Discharge
timeFrame: Within 7 days after discharge
measure: Number of Participants Who Follow-up With Outpatient Medical Within 30 Days of Hospital Discharge
timeFrame: Within 30 days after discharge
measure: Number of Participants Who Follow-up With Outpatient Mental Health Services Within 7 Days of Hospital Discharge
timeFrame: Within 7 days after discharge
measure: Number of Participants Who Follow-up With Outpatient Mental Health Services Within 30 Days of Hospital Discharge
timeFrame: Within 30 days after discharge
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Bronx Care Health System
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Thomas Smith, MD
role: PRINCIPAL_INVESTIGATOR
References: