跳至主要内容
临床试验/NCT00466323
NCT00466323已完成不适用

The Effectiveness of FMPO in Improving the Quality of Care for Persons With Severe Mental Illness

US Department of Veterans Affairs4 个研究点 分布在 1 个国家目标入组 238 人开始时间: 2007年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
238
试验地点
4
主要终点
Family-Clinician Contact (Including Contact With FMPO Clinician)

研究概览

简要总结

The purpose of this study is to learn how to help veterans play a stronger role in shaping their mental health care. Specifically we want to see if we can help veterans improve their mental health treatment by helping them decide if they want to involve family in their mental health treatment, and if so, how. The study will compare a "family member provider" program to an "enhanced treatment as usual approach" in achieving these goals.

详细描述

Previous research demonstrates that when families are active participants in the clinical care of persons with SMI, veterans experience improved outcomes, including treatment retention, vocational services participation, and empowerment. Numerous controlled trials show that when family involvement achieves the level of intensity and family psychoeducation (FPE), relapse rates are cut in half, and treatment adherence, clinical symptoms, and patient functioning are improved. However, despite these demonstrated benefits, rates of family involvement in the VA are unacceptably low. Even minimal family-clinician contact occurs for only one third of VA SMI patients, a lower rate than in non-VA systems of care. Therefore, it is not surprising that FPE, an intensive form of family-clinician contact, is almost never offered in the VA. In fact, a national VA survey conducted within the last three years indicated that 0% of VAs offer FPE programs conforming to EBP guidelines. Our previous experience further suggests that these deficits in care are due to combinations of provider, patient, and family factors, and that the VA presents specific challenges to implementing existing model programs, including FPE. We therefore believe it is necessary to approach the challenge of increasing family involvement in a step-wise fashion, first by engaging families in the processes of care, before trying to enlist them in more intensive programs such as FPE. Further, family engagement would likely be most effective if it builds on a foundation that empowers consumers to make informed choices regarding the involvement of relatives in care. Our group has developed and piloted a new, family-engagement approach that is gradual, patient-centered, recovery-based, and can address various barriers to improving care. It is manualized and thus replicable. The proposed study will implement and further evaluate this intervention, the brief Family Member Provider Outreach (FMPO).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-70 years
  • Diagnosis of a psychotic disorder in keeping with criteria established by the Serious Mental Illness Treatment Research and Evaluation Center (SMITREC){{646}} (schizophrenic disorders (295.0-295.9), affective psychoses (296.1, 296.4-296.8) and other psychotic diagnoses (297.0-298.9)) or diagnosis of Major Depression with psychotic features (296.xx)
  • Decisional capacity to provide informed consent
  • At least two outpatient visits within last six months
  • At least monthly face-to-face contact for one hour or more with a patient-identified family member or caregiver
  • Assessment by the treating therapist or psychiatrist that the patient is clinically stable enough to participate in the program.
  • Family Member/Caregiver Inclusion Criteria
  • Age 18-80 years
  • Decisional capacity to provide informed consent
  • Permission from veteran to be contacted

排除标准

  • Patients whose families have attended the FPE group within the last six months
  • Patients whose families have had at least monthly clinician contact in the last six months
  • Patients who are currently homeless
  • Patients who participated in the FMPO pilot.
  • Family Member/Caregiver Exclusion Criteria:
  • Individuals who do not meet the inclusion criteria
  • Individuals who participated in the FMPO pilot.

结局指标

主要结局

Family-Clinician Contact (Including Contact With FMPO Clinician)

时间窗: Within 6 months of intervention

Chart review looking at the any clinician contact with veteran's family members

Family-Clinician Contact (Not Including Notes From FMPO Clinicians)

时间窗: Within 6 months of intervention

Chart review looking at the any clinician contact with veteran's family members

次要结局

  • Consumer's Recovery Rating - MHRM - Overcoming Stuckness Sub Score(Within 6 month of the intervention)
  • Consumer's Recovery Rating - MHRM Total Score(Within 6 months of intervention)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (4)

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