Schizophrenia, Medical Complication
Conditions
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
Study design
Intervention model description
Prospective cohort with comparison group
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| 7 Days Hospital Inpatient All-cause Readmission Rates | Within 7 days following discharge | Rates of hospital inpatient readmission within 7 days following discharge |
| 30 Days Hospital Inpatient All-cause Readmission Rates | Within 30 days following discharge | Rates of hospital inpatient readmission within 30 days following discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 Discharge | Within 30 days after discharge | Number 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 Discharge | Within 7 days after discharge | Number 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 Discharge | Within 30 days after discharge | Number 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
| Arm | Count |
|---|---|
| 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 |
| Total | 15 |
Baseline characteristics
| Characteristic | Critical Time Intervention | Total | Treatment as Usual |
|---|---|---|---|
| Age, Continuous | 51.3 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 Participants | 6 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 9 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 12 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 3 Participants | 1 Participants |
| Region of Enrollment United States | 10 participants | 15 participants | 5 participants |
| Sex: Female, Male Female | 8 Participants | 9 Participants | 1 Participants |
| Sex: Female, Male Male | 2 Participants | 6 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 5 |
| other Total, other adverse events | 0 / 10 | 0 / 5 |
| serious Total, serious adverse events | 0 / 10 | 0 / 5 |
Outcome results
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Critical Time Intervention | 30 Days Hospital Inpatient All-cause Readmission Rates | 7 Participants |
| Treatment as Usual | 30 Days Hospital Inpatient All-cause Readmission Rates | 0 Participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Critical Time Intervention | 7 Days Hospital Inpatient All-cause Readmission Rates | 3 Participants |
| Treatment as Usual | 7 Days Hospital Inpatient All-cause Readmission Rates | 0 Participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Critical Time Intervention | Number of Participants Who Follow-up With Outpatient Medical Within 30 Days of Hospital Discharge | 9 Participants |
| Treatment as Usual | Number of Participants Who Follow-up With Outpatient Medical Within 30 Days of Hospital Discharge | 4 Participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Critical Time Intervention | Number of Participants Who Follow up With Outpatient Medical Within 7 Days of Hospital Discharge | 7 Participants |
| Treatment as Usual | Number of Participants Who Follow up With Outpatient Medical Within 7 Days of Hospital Discharge | 4 Participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Critical Time Intervention | Number of Participants Who Follow-up With Outpatient Mental Health Services Within 30 Days of Hospital Discharge | 4 Participants |
| Treatment as Usual | Number of Participants Who Follow-up With Outpatient Mental Health Services Within 30 Days of Hospital Discharge | 1 Participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Critical Time Intervention | Number of Participants Who Follow-up With Outpatient Mental Health Services Within 7 Days of Hospital Discharge | 1 Participants |
| Treatment as Usual | Number of Participants Who Follow-up With Outpatient Mental Health Services Within 7 Days of Hospital Discharge | 0 Participants |