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
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Yale University
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Medication Adherence
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
MAPP Trained Case Managers
Consumers assigned to case managers who receive training in the Milestones of Adjustment Post-Psychosis Recovery Model
Intervention: 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
Intervention: Training in all modules except MAPP Recovery Model (Behavioral)
Outcomes
Primary Outcomes
Medication Adherence
Time Frame: 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.
Secondary Outcomes
- Psychological Adjustment Post-Psychosis(2 years)
- Quality of Life(2 years)
- Symptom Management(2 years)