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临床试验/NCT03637296
NCT03637296终止不适用

Adapting Critical Time Intervention to Support Inpatient Medical Care Transition

New York State Psychiatric Institute4 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2019年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
15
试验地点
4
主要终点
7 Days Hospital Inpatient All-cause Readmission Rates

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

7 Days Hospital Inpatient All-cause Readmission Rates

时间窗: Within 7 days following discharge

Rates of hospital inpatient readmission within 7 days following discharge

30 Days Hospital Inpatient All-cause Readmission Rates

时间窗: Within 30 days following discharge

Rates of hospital inpatient readmission within 30 days following discharge

次要结局

  • 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 Within 30 Days of Hospital Discharge(Within 30 days after discharge)
  • 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 Within 30 Days of Hospital Discharge(Within 30 days after discharge)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tom Smith

Clinical Psychiatrist

New York State Psychiatric Institute

研究点 (4)

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