Patient-Centered Medication Adherence Intervention for Schizophrenia (AMAIS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00144027
First received: September 1, 2005
Last updated: July 29, 2014
Last verified: July 2014
  Purpose

Efficacious antipsychotic medication treatments for schizophrenia are available; however , antipsychotic regimens frequently do not achieve their potential because of poor medication adherence. To date, medication adherence interventions have not been widely adopted or sustained in "real-world" practice settings. One reason for this is the substantial resource investment necessary to implement and sustain available interventions. In response to these problems, we developed a patient-centered adherence intervention based on patient-identified barriers, facilitators, and motivators (BFMs) for medication adherence. The intervention includes a BFM survey (checklist and preference weighting exercise to determine the patient's most important BFM) and a brief list of adherence enhancing suggestions (Options List) tailored to the patient-identified BFMs and compatible with CPRS. The long-term objective of this proposed research is to improve antipsychotic medication adherence and clinical outcomes for patients with schizophrenia using a cost-effective medication adherence intervention. The short-term objectives are to refine and test a patient-centered medication adherence intervention for VA patients with schizophrenia and specifically to: 1. Enhance the feasibility and acceptability of the BFM intervention by reducing the burden on patients and mental health providers through BFM checklist item reduction, provider intervention input, and patient intervention input. We hypothesize that our use of end-user input will result in at least 80% of intervention patients having documentation of a BFM intervention in CPRS. 2. Compare the effects of the BFM intervention versus usual care on changes in medication adherence and schizophrenia symptom severity. We hypothesize that the intervention will result in a) greater medication adherence and b) lower schizophrenia symptom severity than usual care. 3. Exploratory objective: compare the effects of the BFM intervention versus usual care on changes in patient health-related quality of life. We hypothesize that the intervention will result in greater health-related quality of life than usual care.


Condition Intervention Phase
Schizophrenia
Behavioral: Antipsychotic medication adherence intervention
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Official Title: Patient-Centered Medication Adherence Intervention for Schizophrenia

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Antipsychotic medication adherence, psychosis symptom severity, and health related quality of life at baseline and 6-months [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cost-effectiveness analysis of intervention versus usual care [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: December 2004
Study Completion Date: July 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Arm 1
The control group will receive treatment as usual; meaning patients in the control group will not receive the medication adherence intervention.
Behavioral: Antipsychotic medication adherence intervention
The medication adherence intervention will include using a computer to complete a brief set of questions related to medication adherence before mental health clinic visits.

Detailed Description:

BFM intervention refinement will be accomplished in five phases. Phase one will include reducing the number of items in the BFM checklist by administering the expanded checklist to at least 50 patients with schizophrenia and using the standard psychometric item-reduction strategies to create a shorter checklist. In phase two we will conduct mental health provider focus groups to discuss the content of the Options List and the delivery of the intervention. In phase three we will automate the BFM intervention using an existing web-based computer touch-screen platform. In phase four we will conduct individual patient debriefing interviews with 30 patients to evaluate the understandability of the BFM survey. In phase five we will evaluate the test/re-test reliability of the survey in a new sample of 30 patients. BFM intervention implementation will include a stratified randomization of patients to the BFM intervention or usual care. BFM intervention evaluation will include testing the feasibility, acceptability, and outcomes associated with the intervention versus usual care in a single trial with 200 patients (100 intervention and 100 usual care).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • medical chart diagnosis of schizophrenia or schizoaffective disorder;
  • currently prescribed outpatient antipsychotic medication (oral or depot);
  • patient must have adequate capacity to provide informed consent, understand the nature of the study, and sign an informed consent document.

Exclusion Criteria:

- significant cognitive impairment as indicated by a score > 10 on the Blessed Orientation-Memory-Concentration (BOMC) Test.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00144027

Locations
United States, Arkansas
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
No. Little Rock, Arkansas, United States, 72114-1706
Sponsors and Collaborators
Investigators
Principal Investigator: Jeffrey M. Pyne, MD Central Arkansas Veterans Healthcare System (North Little Rock)
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00144027     History of Changes
Other Study ID Numbers: IIR 03-257
Study First Received: September 1, 2005
Last Updated: July 29, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
patient non-adherence
intervention studies

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on August 01, 2014