Patient-Centered Medication Adherence Intervention for Schizophrenia (AMAIS)
April 6, 2015 updated by: US Department of Veterans Affairs
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Actual)
75
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arkansas
-
No. Little Rock, Arkansas, United States, 72114-1706
- Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
The control group will receive treatment as usual; meaning patients in the control group will not receive the medication adherence intervention.
|
|
|
Experimental: Antipsychotic adherence intervention
Antipsychotic Medication Adherence Intervention which included the Barriers, Facilitators, and Motivators Checklist summary and Adherence tips provided in hard copy to patient and electronic copy to mental health provider.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Antipsychotic Medication Adherence
Time Frame: 6-months
|
The self-report adherence measure asked patients to think about the past four weeks and report to what extent they took their medication for mental, emotional, or nervous problems and report the result on a 5-point Likert scale ranging from 'I never missed taking my medicine' to 'I stopped taking the medicine altogether'.
Patients who received depot injections were asked to think about the past six months.
Self-report adherence was defined as 1=I never missed taking my medicine' and 0=any other response to the medication adherence question.
|
6-months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jeffrey M. Pyne, MD, Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2004
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
July 1, 2009
Study Registration Dates
First Submitted
September 1, 2005
First Submitted That Met QC Criteria
September 1, 2005
First Posted (Estimate)
September 2, 2005
Study Record Updates
Last Update Posted (Estimate)
April 24, 2015
Last Update Submitted That Met QC Criteria
April 6, 2015
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIR 03-257
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.