Outcomes of Psychiatric Case Manager Training on Medication Adherence, Progression Through the Four Phases of the MAPP Recovery Model, and Quality of Life in Patients With Schizophrenia
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Medication Adherence
研究概览
简要总结
This nested design clinical outcome study of psychiatric case manager education on disease state, psychopharmacology of schizophrenia, relapse, motivational interviewing, and the process of psychological adjustment post-psychosis (Milestones of Adjustment Post-Psychosis Recovery Model-MAPP) will test the following hypotheses:
- Medication non-adherence in patients with schizophrenia assigned to case managers who receive MAPP training will decrease from their pre-study rate and from the reported national average after one year enrollment compared to consumers not enrolled in the MAPP arm of the study.
- Consumers in the MAPP intervention will have higher Quality of Life Enjoyment and Satisfaction Questionnaire (Q-Les-Q (53) scores than consumers not enrolled in the MAPP at quarterly measures.
- Consumers enrolled in the MAPP intervention arm of the study will successfully complete the first two phases of the MAPP Recovery Model in one year.
- Consumers in the MAPP intervention arm will have greater symptom reductions at quarterly data points compared to consumers not enrolled in the MAPP intervention arm.
详细描述
52 psychiatric case managers will receive manualized training in the disease state of schizophrenia, psychotropic medications, motivational interviewing, and relapse prevention. After randomization, 26 case managers will receive additional manualized training in the process of post-psychotic adjustment. Outcomes of 130 consumers (5 per case manager) related to medication adherence, relapse rates, symptom intensity, and quality of life will be evaluated at quarterly intervals over a two-year period. Outcomes of 130 consumers related to medication adherence, relapse rates, symptom intensity, quality of life, and progression through the phases of postpsychotic adjustment (MAPP-Milestones of Adjustment Post-Psychosis Recovery Model) will be evaluated at quarterly intervals via rating scales over a two-year period and the two groups compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Case Managers
- •Voluntary basis-includes willingness to administer study tools quarterly for two years to at least five consumers from their assigned caseloads and to keep a log of their activities and reactions.
- •Inclusion Criteria for consumer subjects: 130 in each treatment arm
- •A diagnosis of a schizophrenia spectrum disorder as defined by DSMIV TR (63)
- •Males and females at least 21 years of age assigned to case managers
- •Able to understand the requirements of the study
排除标准
- •Case Managers
- •None, all case managers are eligible for the study
- •Exclusion Criteria: Consumers
- •Any DSM-IV Axis I disorder not defined in the inclusion criteria
研究组 & 干预措施
MAPP Trained Case Managers
Consumers assigned to case managers who receive training in the Milestones of Adjustment Post-Psychosis Recovery Model
干预措施: Training in all modules including MAPP Recovery Model (Behavioral)
Non-MAPP trained case managers
Consumers of case managers not trained in the Milestones of Adjustment Post-Psychosis Recovery Model
干预措施: Training in all modules except MAPP Recovery Model (Behavioral)
结局指标
主要结局
Medication Adherence
时间窗: Two years
Specific consumer medication adherence outcome data will be collected quarterly for both groups for two years targeting two specific analyses of change: pharmacy records of prescription refills one year before and quarterly after the educational intervention. These records will be obtained by informed consent from the consumer and respective pharmacies.
次要结局
- Psychological Adjustment Post-Psychosis(2 years)
- Quality of Life(2 years)
- Symptom Management(2 years)